in the united states district court for the ......2016/08/12 · in the united states district...

IN THE UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF PENNSYLVANIA

JASON SILVER 2720 Chambersburg Rd. Biglerville, PA 17307 Plaintiff, v. MEDTRONIC, INC. 710 Medtronic Parkway, Minneapolis, Minnesota 55432; MEDTRONIC NEUROMODULATION, a division of Medtronic, Inc. 7000 Central Avenue NE, Fridley, Minnesota 55432; MEDTRONIC PUERTO RICO OPERATIONS, INC.; Ceiba Norte Industrial Park Road 31, Km. 24, HM 4 Call Box 4070, Junco 00777-4070, Puerto Rico; and MEDTRONIC LOGISTICS, LLC, 710 Medtronic Parkway, Minneapolis, Minnesota 55432 Defendants.

Case No.___________________ COMPLAINT JURY TRIAL DEMANDED

COMES NOW, Plaintiff Jason Silver, by and through his undersigned attorneys, and

hereby files this Complaint against the above-named Defendants, Medtronic, Inc.; Medtronic

Neuromodulation, a division of Medtronic, Inc.; Medtronic Puerto Rico Operations, Inc.; and

Case 1:16-cv-01682-JEJ Document 1 Filed 08/12/16 of 41

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Medtronic Logistics, LLC (collectively “Defendants” or “Medtronic”), and states and alleges as

follows:

I. INTRODUCTION

1. This is a products liability action seeking damages for personal injuries sustained

by Jason Silver arising from his use of a defective product designed, manufactured, labeled, and

distributed, or otherwise placed into the stream of commerce by Defendants and/or each of them.

As set forth herein, Mr. Silver suffered severe and permanent injuries and hospitalization as a

foreseeable, direct, and proximate result of defects in his Medtronic SynchroMed® II

Programmable Implantable Infusion Pump System for intrathecal drug delivery, which was

implanted in his abdomen. Mr. Silver brings this action to recover damages caused by

Defendants’ conduct.

II. THE PARTIES, JURISDICTION, AND VENUE

2. Plaintiff Jason Silver is a citizen of Pennsylvania and resides in Biglerville,

Pennsylvania. At all times relevant hereto, Plaintiff Jason Silver was a citizen of Pennsylvania

and resided in York Springs, Pennsylvania.

3. At all times relevant hereto, Defendant Medtronic, Inc., was and is a corporation

or other business entity with its principal place of business at 710 Medtronic Parkway,

Minneapolis, Minnesota 55432, and was involved in the design and/or assembly and/or

manufacture and/or testing and/or packaging and/or labeling and/or marketing and/or distribution

and/or sale and/or promotion and/or was otherwise involved in the placing in the stream of

commerce medical devices and a device specifically called the SynchroMed® II Programmable

Implantable Infusion Pump System (hereinafter referred to as “SynchroMed® II Device”).1

1 The term “SynchroMed II Device” includes the intrathecal sutureless catheter.


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4. At all times relevant hereto, Defendant Medtronic Neuromodulation, a division of

Medtronic, Inc., was and is a corporation or other business entity with its principal place of

business at 7000 Central Avenue NE, Fridley, Minnesota 55432, and was involved in the design

and/or assembly and/or manufacture and/or testing and/or packaging and/or labeling and/or

marketing and/or distribution and/or sale and/or promotion and/or was otherwise involved in the

placing in the stream of commerce medical devices and the SynchroMed® II Device.

5. At all times relevant hereto, Defendant Medtronic Puerto Rico Operations Co.,

was and is a corporation or other business entity and a wholly owned subsidiary of Defendant

Medtronic, Inc., with its principal place of business in Ceiba Norte Industrial Park Road 31, Km.

24, HM 4 Call Box 4070, Junco 00777-4070, Puerto Rico, and was involved in the design and/or

assembly and/or manufacture and/or testing and/or packaging and/or labeling and/or marketing

and/or distribution and/or sale and/or was otherwise involved in placing in the stream of

commerce medical devices and the SynchroMed® II Device.

6. At all times relevant hereto, Defendant Medtronic Logistics, LLC, was and is a

limited liability corporation or other business entity and wholly owned subsidiary of Defendant

Medtronic, Inc., with its principal place of business at 710 Medtronic Parkway, Minneapolis,

Minnesota 55432, and was involved in the design and/or assembly and/or manufacture and/or

testing and/or packaging and/or labeling and/or marketing and/or distribution and/or sale and/or

was otherwise involved in placing in the stream of commerce medical devices and the

SynchroMed® II Device.

7. At all times relevant to this action, Defendants were authorized to do business

within the Commonwealth of Pennsylvania, and manufactured, supplied, distributed, formulated,


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prescribed, marketed, and sold or otherwise placed into the stream of commerce the

SynchroMed® II Device within the Commonwealth of Pennsylvania.

8. This Court has jurisdiction over this action pursuant to 28 U.S.C. § 1332, as all

parties are citizens of different states and the amount in controversy exceeds the sum or value of

$75,000, exclusive of interests and costs.

9. Venue is proper pursuant to 28 U.S.C. § 1391(b), as a substantial part of the

events or omissions giving rise to this action occurred in this judicial district.

III. FACTUAL ALLEGATIONS

10. Jason Silver is a fifty-two (52) year old man who suffered serious injuries from a

malfunctioning and defective SynchroMed® II Device. This Device was designed, tested,

manufactured, produced, processed, assembled, inspected, distributed, marketed, labeled,

promoted, packaged, advertised for sale, placed in the stream of commerce, and sold or

otherwise provided to Mr. Silver by the Defendants.

11. Mr. Silver’s injuries alleged herein proximately resulted from the negligent and/or

reckless and/or other wrongful acts and omissions, and fraudulent representations of Defendants

and/or each of them, all of which occurred within the jurisdiction of this Court.

12. In 2012, in order to treat chronic pain associated with his diagnosed cervical

radiculopathy and cervicalgia, Mr. Silver was persuaded to have a SynchroMed® II Device

implanted in his abdomen to administer pain medication into the intrathecal space of his spine.

13. On December 7, 2012, Mr. Silver had a SynchroMed® II Device, comprised of a

Model #8637-40 pump (Serial #NGV471492H) and an intrathecal catheter, implanted in his

body. This procedure took place at WellSpan York Hospital in York, Pennsylvania. The


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SynchroMed® II Device implanted in his body was intended to deliver a programmed amount of

pain medication into his spine, reducing or eliminating the need for oral medications.

14. For several months after Mr. Silver had his SynchroMed® II Device implanted,

his pain improved. However, in the summer of 2014, Mr. Silver suffered a severe overdelivery

of pain medication from his Device. This resulted in severe pain, nausea, and lack of mobility.

Mr. Silver was accordingly taken to the hospital.

15. On August 12, 2014, Jason Silver underwent a procedure to remove his

malfunctioning SynchroMed® II Device due to its malfunctions.

16. As a result of the aforementioned defects and malfunctions, Jason Silver’s

defective SynchroMed® II Device failed to deliver the prescribed medication as programmed.

These defects and malfunctions resulted a complete failure to deliver medication, causing severe

damage and injury to Mr. Silver.

17. In addition, Mr. Silver’s defective and malfunctioning SynchroMed® II Device

necessitated a removal surgery. The removal of the defective device and replacement of a new

device is a serious, invasive, and dangerous procedure.

18. Throughout the history of the manufacture of the SynchroMed® II Device, the

U.S. Food & Drug Administration (FDA) has repeatedly notified Medtronic that their

manufacture of the SynchroMed® II Device failed to conform to manufacturing requirements

enumerated in federal regulations and statutes. These federal violations caused the defects and

malfunctions in Jason Silver’s SynchroMed® II Device, which caused his injuries and damages

alleged herein

19. Throughout the history of the manufacture of the SynchroMed® II Device,

Medtronic has shown an indifference to federal manufacturing requirements. Further,


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Medtronic, with full knowledge that they were manufacturing the SynchroMed® II Device in

violation of law, nonetheless demonstrated a pattern of delayed responses or complete failures to

respond to reported and known safety issues with the SynchroMed® II Device.

20. Because of Medtronic’s years-long pattern of indifference to regulatory authority,

noncompliance with federal manufacturing requirements, and violations of federal law, the U.S.

Department of Justice and the U.S. Department of Health and Human Services on April 27, 2015

filed a Complaint against Medtronic requesting a Consent Decree for Permanent Injunction

against the manufacture, distribution, and sale of the SynchroMed® II Device.

21. As a foreseeable, direct and proximate result of Medtronic’s conduct described

herein, Jason Silver has suffered and will continue to suffer damages, including lost wages and

benefits, diminished wages and future earnings, mental anxiety and anguish, loss of self-esteem,

and medical bills in amounts to be proven at trial.

A. The SynchroMed® II Device

22. The SynchroMed® II Device is a programmable drug infusion system implanted

in the body for drug delivery. The SynchroMed® II Device includes an infusion pump connected

to a thin, flexible catheter attached to the intrathecal space (spinal canal) of the patient, into

which the Device delivers medication. The relevant SynchroMed® II Device was used to

administer pain medication to Jason Silver.

23. The SynchroMed® II Device is a Class III medical device, approved by the FDA

through the Pre-Market Approval (PMA) process in 1988. Since the initial approval under PMA

860004, Medtronic sought FDA approval of at least one hundred ninety-one (191) supplements

or changes to the originally-approved Device.


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24. The pump of the SynchroMed® II Device is supplied in twenty (20) and forty

(40) ml reservoir sizes, Models #8637-20 and 8637-40 respectively, and the Device is approved

solely for the following uses:

a. the chronic epidural/intrathecal infusion of Infumorph (preservative-free

morphine sulfate sterile solution) and Prialt® (preservative-free ziconotide sterile

solution) for the management of pain;

b. the chronic intrathecal infusion of Baclofen (Lioresal) for the management of

severe spasticity; and

c. the chronic intravascular infusion of floxuridine (FDUR) and methotrexate for the

treatment of primary or metastatic cancer.

25. The entire SynchroMed® II Device is implanted and remains under the skin. A

clinician measures a precise amount of medication and injects the medication into the pump’s

reservoir fill port. The medication passes through a reservoir valve and into the pump reservoir.

At normal body temperatures, pressurized gas, used as a propellant, is stored below the reservoir

and it expands and exerts constant pressure on the reservoir. This pressure pushes the

medication into the pump tubing. The battery-powered electronics and motor gears deliver a

programmed dose of medication through the tubing out through a catheter port and into a

catheter. Medication delivery then continues through the catheter tubing and into the intrathecal

space of a patient.

26. The intrathecal catheters and sutureless revision kits of the SynchroMed® II

Device are designed to connect the pump with the patient’s intrathecal space. Each catheter has

a pre-attached strain relief sleeve, a connector pin, and a sutureless pump connector that connects

to the SynchroMed® II pump.


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27. In their marketing, Medtronic represented the SynchroMed® II Device as “safe

effective, reliable medical devices; implanted by safe and effective, minimally invasive surgical

techniques for the treatment of medical conditions, including the controlled release of Morphine

for the treatment of patients suffering from chronic and severe pain.”

28. Medtronic marketed the SynchroMed® II Device directly to patients through

conversations with Medtronic employees, patient testimonials, and colorful brochures with

images of individuals smiling and pain medication patients riding motorcycles. Medtronic’s

representations to patients include:

a. “a safer way to receive pain medication”;

b. “help you rejoin life so you can get back to the activities and people that make

you happiest”;

c. “allows you to ‘Tame your Pain’ ”;

d. “reduce your need for oral pain medications”;

e. “provide peace of mind knowing that you’ve selected a drug delivery system that

was manufactured by Medtronic . . .”

f. “give reassurance because only Medtronic offers a programmable drug delivery

system that is FDA approved for MRI scans . . .”;

g. “increase your confidence when you consider that more than 150,000 people

worldwide have used Medtronic drug delivery therapy to manage their chronic

pain”;

h. “drug delivery therapy from Medtronic is a proven safe and effective therapy”;

i. “Medtronic drug delivery therapy has been tested, is shipped sterile, and is FDA

approved”; and


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j. “more doctors trust Medtronic than any other company offering drug delivery

therapy.”

B. FDA Pre-Market Approval (PMA) of the SynchroMed® II Device

29. Premarket approval (PMA) is the FDA process of scientific and regulatory review

to evaluate the safety and effectiveness of Class III medical devices. Class III medical devices

are those that 1) support or sustain human life, 2) are of substantial importance in preventing

impairment of human health, or 3) which present a potential, unreasonable risk of illness or

injury. Due to the level of risk associated with Class III devices, these devices require a

premarket approval (PMA) application under Section 515 of the Federal Food Drug and

Cosmetic Act (FD&C Act) before they can be sold in the United States. As mentioned, the

SynchroMed® II Device is a Class III medical device.

30. In a PMA application, the applicant is required to supply information to the FDA.

The information required includes: a) device description, b) clinical safety trials, c) methods of

its product testing, d) design of the device and specific manufacturing controls, e) outcome

evaluation, and f) proposed labeling. The FDA does not conduct independent testing on a

medical device in a PMA application. The FDA reviews the documentation provided to them by

the PMA applicant and relies on the veracity of the company. The PMA applicant (in this

circumstance, Medtronic) is solely responsible for submitting all truthful and necessary

documentation to the FDA.

31. Once an application for PMA is approved, the holder (Medtronic) must comply

with any and all post approval requirements established by the FDA and federal regulations. The

legal requirements include but are not limited to: post marketing monitoring, evaluating and

reporting adverse events, and compliance with Current Good Manufacturing Practices (CGMPs).


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Regulations prohibit the PMA holder from selling an adulterated or misbranded product, and

prohibit promoting a device for unapproved uses.

32. In particular, federal regulations require a PMA applicant such as Medtronic to

comply with the following requirements:

a. Review, evaluate, and report to the FDA, adverse events associated with the

medical device.

i. Report individual adverse events within thirty (30) days after becoming

aware of an adverse event or aware of a reportable death, serious injury or

malfunction (21 C.F.R. § 803.10(c)(1)), and

ii. Report individual adverse events no later than five (5) work days after

becoming aware of “a reportable event that requires remedial action to

prevent an unreasonable risk of substantial harm to the public health . . .”

(21 C.F.R. § 803.10(c)(2)(i)).

b. Quality System. Establish and maintain a quality system that is appropriate for

the specific medical devices designed or manufactured and that meets the

requirement of this part. (21 C.F.R. § 820.5).

c. Management Responsibility. Management with executive responsibility shall

establish its policy and objectives for, and commitment to quality. (21 C.F.R. §

820.20).

d. Qualified Personnel. Have sufficient personnel with the necessary educational

background, training, and experience to assure that all activities required by this

part are correctly performed. (21 C.F.R. § 820.25).


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e. Corrective and Preventative Action (CAPA). Establish and maintain

procedures for implementing corrective and preventive action, and document all

activities under this section. (21 C.F.R. § 820.100).

f. Complaint Files. Maintain complaint files, processed in a uniform and timely

manner, oral complaints must be documents and must be evaluated to determine

whether the complaint represents a reportable event under Medical Device

Reporting. (21 C.F.R. § 820.198).

g. Statistical Techniques. Establish and maintain procedures for identifying valid

statistical techniques required for establishing controlling and verifying the

acceptability of process capability and product characteristics. (21 C.F.R.§

820.250).

h. Misbranded Drugs and Devices Prohibited. A device shall be deemed to be

“misbranded” if its label is false or misleading in any particular. (21 C.F.R. §

820, et al.).

i. Adulterated Products Prohibited. If the manufacturer fails to ensure that the

methods used in, or the facilities or controls used for, their manufacture, packing,

storage, or installation are not in conformity with applicable requirements,

including but not limited to the Current Good Manufacturing Practice (CGMP)

requirement of the Quality System regulations found at Title 21 Code of Federal

Regulations Section 820, then such products are considered “adulterated.” (21

U.S.C. § 351 (h) (emphasis added).

j. Prohibition of Off-Label Promotion. A product may not be manufactured

packaged, stored, labeled, distributed, advertised, or promoted in a manner that is


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inconsistent with any conditions to approval specified in the PMA approval order

for the device. (21 C.F.R. § 814.80).

C. Violations of federal law resulting in Jason Silver’s defective and malfunctioning SynchroMed® II Device

33. Medtronic, in their manufacture of the SynchroMed® II Device, violated federal

law governing manufacture and quality control of PMA medical devices, which was discovered

during a series of inspections by the FDA at Medtronic’s SynchroMed® II Device manufacturing

and quality control plants in Minneapolis, Minnesota and Puerto Rico.

34. The inspections were followed by a series of Warning Letters to Medtronic that

identified federal manufacturing and quality control violations at the plants, ultimately leading to

an April 27, 2015 Complaint Requesting a Permanent Injunction filed against Medtronic by the

U.S. Department of Justice and U.S. Department of Health and Human Services, and a Court-

Ordered Consent Decree imposing a moratorium on the manufacture, sale, and distribution of the

SynchroMed® II Device in violation of federal law.2

35. The Warning Letters, agency action, and Court Order speak to the seriousness of

Defendants’ violations of federal law and general negligence in the manufacture of the


36. In a 2006 Warning Letter, after an inspection of Medtronic’s manufacturing plant

located at 800 53rd Avenue NE, Minneapolis, Minnesota, the FDA identified “Significant

Deviations” from CGMPs committed by Medtronic while manufacturing their SynchroMed® II

Devices, including that which was implanted in Jason Silver’s body. Given these “significant

deviations,” the SynchroMed® II Devices were found to be “adulterated.” These “significant

deviations” include, but are not limited to, the following:

2 Complaint for Permanent Injunction, attached as Exhibit 1.


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a. Failure to control production processes to ensure that a device conforms to its

specification. (21 C.F.R. § 820.70(a));

b. Failure to implement corrective and preventive action procedures addressing the

investigation of the cause of nonconformities. (21 C.F.R. § 820.100(a)(2));

c. Failure to implement changes in methods and procedures needed to correct and

prevent identified quality problems. (21 C.F.R. § 820.100(a)(5));

d. Failure to identify all of the actions needed to correct and prevent the recurrence

of nonconforming product and other quality problems. (21 C.F.R. §

820.100(a)(3)); and

e. Failure to implement procedures to ensure that device history records for each

batch, or unit are maintained to demonstrate that the device is manufactured in

accordance with regulations. (21 C.F.R. § 820.184).

The FDA Warning Letter continued: “The specific violations noted in this letter and the Form

FDA-483 . . . may be symptomatic of serious underlying problems in your firm’s manufacturing

quality assurance systems.”3

37. The FDA inspected the same Minneapolis Medtronic facility less than a year

later, and on July 3, 2007 issued another Warning Letter concerning the SynchroMed® II

Device. The FDA again warned Medtronic that their devices manufactured at the Minneapolis

facility were “adulterated” and “misbranded.” A partial list of the violations the FDA found

during the 2007 inspection includes:

3 August 29, 2006 FDA Warning Letter and Form FDA 483, dated January 24, 2007, attached collectively as Exhibit 2.


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a. Medtronic failed to implement complaint handling procedures to ensure that all

complaints are evaluated to determine whether the complaint represents an event

that must be filed as a Medical Device Report (MDR).

b. Medtronic failed to enter several medical and/or scientific literature articles

discussing adverse events relating to devices the plant manufactured in the

reporting system and failed to evaluate whether the adverse event related articles

were required to be reported to the FDA under 21 C.F.R. § 803.50.

c. Medtronic failed to submit MDR reports within thirty (30) days of receiving or

otherwise becoming aware of information that reasonably suggests that a

marketed device may have caused or contributed to a death or serious injury (21

C.F.R. § 803.50(a)(1)).

d. In that Letter, the FDA warned Medtronic: “[y]our firm has several procedures for

Medical Device Reporting and Adverse Drug Experience Reporting. These

procedures, in turn reference several other procedures. You firm’s current

problems regarding MDR reporting, as discussed above in this Warning letter,

may be exacerbated by the complexity of your procedures and might have

contributed to your firm’s deviations from the regulations regarding MDR

reporting.”4

38. The FDA inspection also revealed several ongoing violations at Medtronic’s

Minneapolis Plant’s Quality System that were noted in a Form 483, stating “[t]he specific

violations noted in this letter and Form FDA 483 may be symptomatic of serious underlying

4 July 3, 2007 FDA Warning Letter, attached as Exhibit 3.


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problems in your firm’s manufacturing and Quality Assurance systems.” Specifically, the FDA

warned that Medtronic:

a. failed to achieve consistent compliance in areas such as design controls. (21

C.F.R. § 820.30); and

b. failed to achieve consistent compliance in Corrective and Preventative Action

(CAPA). (21 C.F.R. § 820.100).5

39. On June 1, 2009, the FDA issued a “Warning Letter” to Medtronic concerning

their manufacturing facility in Juncos, Puerto Rico, detailing multiple violations of “Current

Good Manufacturing Practice (CGMP) requirement of the Quality System (QS) regulation found

at Title 21, Code of Federal Regulations (C.F.R.) part 820” based on inspections conducted in

late 2008. Based upon those violations, the FDA determined that Medtronic’s SynchroMed® II

Devices were “adulterated” within the meaning of 831(h) of the Federal Food, Drug, and

Cosmetic Act, 21 U.S.C. et seq. “in that the methods used in, or the facilities or controls used for,

their manufacture, packing, sorting, or installation are not in conformity with the Current Good

Manufacturing Practice (CGMP) requirements of the Quality System regulation found at Title 21

Code of Federal Regulations (C.F.R.) Part 820.”6

40. The 2009 FDA Warning Letter concerning the Puerto Rico manufacturing plant

specifically cited Medtronic for the following with regard to the SynchroMed® II Device:

a. Failure to establish and maintain process control procedures that describe any

process controls necessary to ensure conformance to specifications, which shall

5 Id.

6 June 1, 2009 FDA Warning Letter, attached as Exhibit 4.


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include monitoring and control of process parameters and component and device

characteristics during production;

b. Failure to establish and maintain procedures for implementing corrective and

preventive actions that include identifying the actions needed to correct and

prevent recurrence of non-conforming product and other quality problems as

required by 21 C.F.R. § 820.100(a);

c. Failure to establish and maintain procedures that ensure the Device History

Records (DHRs) for each batch, lot or unit are maintained to demonstrate that the

device is manufactured in accordance with the DHR as required by 21 C.F.R. §

820.184;

d. Failure to review, evaluate and investigate complaint involving the possible

failure of a device, labeling or packaging to meet any of its specifications as

required by 21 C.F.R. § 820.198(c);

e. Failure to report to FDA no later than thirty (30) calendar days after the day that

Medtronic received or otherwise became aware of information from any source,

that reasonably suggests that a device Medtronic marketed: 1) may have caused or

contributed to a death or serious injury; or 2) has malfunctioned and this device or

a similar device that Medtronic marketed would be likely to cause or contribute to

a death or serious injury, if the malfunction were to recur, as required by 21

C.F.R. § 803.50(a);

f. Failure to have a person who is qualified to make a medical judgment reasonably

conclude that a device did not cause or contribute to a death of serious injury, or


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that a malfunction would not likely to cause or contribute to a death or serious

injury if it were to recur, as required by 21 C.F.R. § 803(c)(2); and

g. Failure to ensure that persons qualified to make a medical judgment include

physicians, nurses, risk managers, and biomechanical engineers under 21 C.F.R. §

803.20(c)(2): “[O]ur investigators determine that a product reporting specialist

was making decisions about MDR reportability for the Medtronic SynchroMed®

II Implantable Pump Infusion System. The training record for this particular

employee showed that this person only had a high school diploma with some

additional in-house training.”7

41. At the time of inspection, the FDA informed Medtronic of the following

manufacturing defects in the SynchroMed® II Device:

a. Pumps manufactured without propellant. The FDA noted that while Medtronic

identified this problem in May of 2006, and initiated a corrective and preventative

action (CAPA) investigation in January 2007, Medtronic did not voluntarily recall

the thirteen thousand five hundred fifteen (13,515) devices affected by this defect

until May 2008, a full two (2) years after the defect was identified.

b. Pumps did not show evidence of perforated septum;

c. Pumps were missing a safety mechanism that served to assure that pumps are

never overfilled; and

d. A critical step was left out of the manufacturing process, which is the calculation

of drug reservoir levels and drug dispensing rates. Despite numerous complaints

7 Id.


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that Medtronic received regarding accuracy rates, Medtronic failed to conduct any

type of investigation into this problem.

42. The FDA determined that the SynchroMed® II Device was “misbranded” by

virtue of the cited violation involving the failure or refusal to furnish material or information

required under the statute and regulations relating to information that the devices may have either

caused or contributed to death or serious bodily injury, or malfunctions in such a way that if it

were to recur would be likely to cause or contribute to a death or serious injury.

43. Additionally, while the FDA observed generally that the adequacy of Medtronic’s

responses could not be determined at the time, the FDA noted “the adequacy of your corrective

and preventative measures will be determined during the next inspection.” It specifically noted

that Medtronic’s response to the violation related to the “failure to establish and maintain

procedures for implementing Corrective and Preventive Action (CAPA) procedures at [the

Puerto Rico facility] will be conducted by July 31, 2009.”8

44. In 2012, Medtronic’s Minneapolis manufacturing plant was again inspected by

the FDA. As a result of that inspection, the FDA issued a Warning Letter dated July 17, 2012

identifying Medtronic’s specific violations of federal regulations in the manufacture of

SynchroMed® II Devices including violations of CGMPs and Quality Systems requirements.

The FDA informed Medtronic that the SynchroMed® II Devices were “adulterated.”

45. The FDA cited Medtronic for incomplete complaint data and incorrect coding

decision. The FDA stated this violation “may have compromised Medtronic’s ability to detect

and investigate [safety] signals.”9

8 Id.

9 July 17, 2012 FDA Warning Letter, attached as Exhibit 5.


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46. From February 14, 2013 through April 3, 2013, the FDA again inspected

Medtronic’s Neuromodulation manufacturing plant in Minneapolis. In April 2013, based on its

inspection, the FDA informed Medtronic that the plant failed to manufacture devices that

adequately conform to specifications and instead manufactured devices that were not adequately

controlled. Specifically, Medtronic failed to establish procedures for corrective and preventative

action for problems including:

a. “Feed through shorting” resulting in motor stalls, whereby at least two hundred

ninety-eight (298) serious adverse events have resulted from this defect;

b. Based upon a reported problem with their device, Medtronic failed to implement a

recommendation from its Risk Evaluation Board and delayed any action taken.

Since the decision to delay the action, at least thirty-seven (37) serious adverse

events have been possibly related to the problem; and

c. Medtronic detected signals showing a problem with catheter occlusion, but failed

to update a Health Hazard Assessment for this defect since 2008, with over three

hundred (300) complaints occurring since that time.10

47. Further, the FDA notified Medtronic of the following:

Regulatory approval was received for Supplement 136 to PMA P860004 on December 15, 2011 to change the design of SC Catheter models 8709 SC, 8731 SC, 8596 SC, and Revision Kit model 8578 to mitigate a known field issue associated with CAPA 1507-SC Catheter Occlusion. This design change was implemented via ECO 12-00985, date March 6, 2012, and the new revisions of Catheter models were released to the field in September 2012. However, the previous SC catheter models which do not conform to the current design have continued to be distributed and have been attributed to 60 complaints of catheter occlusion since September 2012.11

10 FDA Form 483, Inspection Observations, Dated Feb. 14, 2013 – April 3, 2013, attached as Exhibit 6.

11 Id.


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D. SynchroMed® II Device recalls initiated by the U.S. Food & Drug Administration

48. Since 2008, the FDA has issued nineteen (19) Class I Recall Actions for the

SynchroMed® II Device. A recall is an action taken to address a problem with a medical device

that violates federal law. Recalls occur when a medical device is defective, when it could be a

risk to health, or when it is both defective and a risk to health.

49. A Class I recall is the most serious recall category issued when there is a

probability that the use of the product could cause serious health consequences or death. Any

drug or medical device that has been the subject of a Class I recall can be deadly or cause serious

life-long injury.

50. Up to December 13, 2012, The Class I and Class II recalls issued for the

SynchroMed® II Device include, but are not limited to:

a. Formation of inflammatory masses near the tip of the intrathecal catheters (Class

I, March 22, 2008);

b. Pumps manufactured without propellant (Class II, September 3, 2008);

c. Battery failure (Class II, September 29, 2009);

d. Inadequate instruction for filling/refilling of pumps causing injection of all or

some of the prescribed drug into the patient’s subcutaneous tissue (Class I,

August 29, 2011);

e. Reduced battery performance leading to sudden loss of therapy (Class I, August

29, 2011);

f. Software failure resulting in incorrectly displayed “scheduled to replace the pump

by” date (Class II, March 30, 2012); and


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g. Use of unapproved (off-label) drugs in the pumps leading to permanent motor

stall and cessation of infusion (December 13, 2012).

51. On June 3, 2013, the FDA issued two (2) Class I recalls related to the Medtronic

SynchroMed® II Implantable Infusion Pump System.

a. The first 2013 recall covers all of the SynchroMed® II pumps implanted

worldwide manufactured from May 1998 through June 2013 and distributed from

April 1999 through June 2013. In the letter, the FDA warned that the following

would happen with the defective pumps:

i. Unintended delivery of drugs during the priming bolus procedure can

result in drug underdelivery and overdelivery, leading to respiratory

depression, coma or death, and

ii. Potential for electrical shorting, internal to the SynchroMed® II

infusion pump, leading to a loss of or reduction in therapy, resulting in

serious adverse health consequences including death. At the time of

the 2013 recalls, there were two hundred sixty-one thousand, one

hundred nine (261,109) SynchroMed® II Implantable Infusion Pumps

System implanted worldwide.

b. The second 2013 recall affects all Sutureless Connector Intrathecal Catheters in

the SynchroMed® II Device, Models #8709SC, 8731SC, and Sutureless Revision

Kits, Models #8596SC, and 8578 with a “use by” date of August 25, 2014. In the

recall, the FDA noted the reasons for the recall:

i. “The sutureless Connector Intrathecal Catheter connector has been

redesigned to reduce the potential for occlusion, which is the blockage


22

or stoppage of drug flow due to misalignment at the point where the

catheter connects to an implantable pump. Medtronic is removing all

unused products that were manufactured with the previous design.

Medtronic recommends the previous design of Sutureless connector

Intrathecal Catheter Products no longer be used due to greater potential

for misalignment and subsequent occlusion.”

ii. “This product may cause serious adverse health consequences,

including drug under dose, loss of symptom relief, drug withdrawal

symptoms caused by the lack of drug delivery to the intrathecal space,

and/or death.”

E. The United States of America files a Complaint for Permanent Injunction against Medtronic, Inc. and individuals S. Omar Ishrak and Thomas M. Tefft

52. On April 27, 2015, the United States Department of Justice and United States

Department of Health and Human Services filed a Complaint for Permanent Injunction against

Medtronic, Inc. and S. Omar Ishrak and Thomas M. Tefft with respect to their manufacture of

the SynchroMed® II Device.12

53. The Complaint alleges that Medtronic, S. Omar Ishrak, and Thomas M. Tefft “are

well aware that their practices violate the Act. FDA has repeatedly warned Defendants, both

orally and in writing, about their violative conduct, and has emphasized the importance of

Defendants’ compliance with the Act.”

54. In addition to the cited Warning Letters, the Complaint alleges that

representatives of Medtronic attended a meeting with FDA’s Center for Devices and

Radiological Health and Minneapolis District Office on January 31, 2013. At this meeting,

12 See Exhibit1.


23

“Defendants stated that they were aware of the violations at their facilities and were taking steps

to correct them.”

55. The Complaint further alleges Medtronic made promises to correct their

violations in written responses to each inspection; however, the Complaint alleged that none of

the responses contained adequate evidence that Medtronic corrected their deviations.

56. The United States Attorney stated in the Complaint that, “[b]ased upon

Defendants’ conduct, Plaintiff believes that, unless restrained by order of this Court, Defendants

will continue to violate 21 U.S.C. §§ 331(a) and (k) [introducing into interstate commerce any

article of device that is adulterated, or causing any article of device to become adulterated

within the meaning of 21 U.S.C. § 351 (h) while such devices are held for sale after shipment in

interstate commerce].”

57. The United States of America’s Complaint requested a permanent injunction to

restrain Medtronic, in their manufacture of the SynchroMed® II Device, from their continued

violation of federal regulations, and,

That the Court order Defendants and each of their directors, officers, agents, representatives, employees, attorneys, successors, and assigns, and any and all persons in active concert or participation with any of them, to cease directly and indirectly manufacturing, packing, labeling, and distributing (domestically and internationally) SynchroMed II implantable infusion pumps at or from its Medtronic’s Neuromodulation faculties, unless and until Defendants’ methods, facilities, and controls used to manufacture, process, pack, label, hold and distribute the SynchroMed II implantable infusion pumps are established, operated, and administered in compliance with 21 USC 360j(f)(1) and the Quality System regulation prescribed in 21 C.F.R. Part 820, and in a manner that has been found acceptable to FDA.13

13 Id.


24

58. On April 27, 2015, United States District Court Judge Joan N. Erickson signed a

Consent Decree of Permanent Injunction against Medtronic preventing the manufacture and

distribution of the Medtronic SynchroMed® Implantable Infusion Pump systems in violation of

the terms of the Consent Decree.14

59. Under the Consent Decree, Medtronic is “permanently restrained and enjoined,

pursuant to 21 U.S.C. § 332(a), from directly or indirectly designing, manufacturing, processing,

packing, labeling, holding, storing, and distributing, importing into or exporting from the United

States of America, at or from any Medtronic Neuromodulation facilities, any model of, or

components or accessories for, its SynchroMed devices.” Under the Consent Decree, the

permanent injunction would be lifted only in the event that Medtronic complies with a series of

enumerated requirements to ensure that it would cease violating federal law in the production of

its SynchroMed® II Device.

60. Upon information and belief, Medtronic continues to produce, distribute, and sell

their SynchroMed® II Device in violation of the Decree.

IV. CAUSES OF ACTION

COUNT I MANUFACTURING DEFECT

61. Plaintiff incorporates by reference, as if fully set forth herein, each and every

allegation contained in the preceding paragraphs of this Complaint.

62. Plaintiff herein asserts claims under Pennsylvania law that parallel Defendants’

duties under federal law governing the manufacture of Plaintiff’s SynchroMed II Device.

14 Consent Decree of Permanent Injunction, attached as Exhibit 7.


25

Plaintiff’s state law claims are based upon and arise from Defendants’ violations of and

deviations from federal requirements in the manufacture of Plaintiff’s Device.

63. Defendants, and each of them, are medical device companies engaged in the

design and/or research and/or manufacture and/or production and/or testing and/or assembling

and/or labeling and/or packaging and/or distribution and/or sale and/or otherwise placing into the

stream of commerce various medical devices intended for human use, as set forth herein,

including the SynchroMed® II Device.

64. At all times relevant hereto, Defendants, and each of them, held themselves out as

knowledgeable and possessing the requisite skill peculiar to the research and/or manufacture

and/or production and/or testing and/or assembling and/or labeling and/or packaging and/or

distribution and/or sale of such product(s).

65. Defendants manufactured, distributed, and sold Plaintiff’s SynchroMed® II

Device. At all times relevant hereto, Plaintiff used his SynchroMed® II Device for its intended

purpose, which is intrathecal delivery of opioid medication for pain.

66. At all times relevant hereto, Medtronic had a duty under federal law to

manufacture Plaintiff’s Device in compliance with specifications imposed during the Pre-Market

Approval for the device, and in compliance with Post Approval federal regulations, including but

not limited to those set out in 21 C.F.R. § 801, et seq., 21 C.F.R. § 803, et seq., 21 C.F.R. § 814,

et seq., 21 C.F.R. § 806, et seq., 21 C.F.R. § 820, et seq., and 21 U.S.C. §§ 351-52. Such

regulations are promulgated to ensure that a manufactured device is free from defects.

67. At all times relevant hereto, Medtronic had a duty under Pennsylvania law to use

reasonable care in the manufacture of their products, which includes a duty to manufacture

Plaintiff’s SynchroMed® II Device in compliance with Medtronic’s own specifications, a duty to


26

prevent non-conforming devices from entering into the stream of commerce, and a duty to

comply with safety regulations applicable to the manufacture of the device. Such duties are

parallel to those imposed under federal law and are expressly excepted from preemption under

21 C.F.R. § 808.1(d)(2), according to which “state or local requirements that are equal to, or

substantially identical to, requirements imposed by or under the [MDA]” are not preempted.

68. Medtronic breached its duty under Pennsylvania law to use reasonable care in that

it failed to ensure that Plaintiff’s SynchroMed® II Device complied with its own specifications

and applicable safety regulations, including federal manufacturing requirements imposed by the

Device’s Pre-Market Approval (PMA) requirements and Post Approval Regulations, and failed

to test and inspect plaintiff’s SynchroMed® II Device before placing it into the stream of

commerce and making it available for sale to Plaintiff.

69. As a result of Medtronic’s violations of federal statutory and regulatory standard

of care and device specific regulations, the SynchroMed® II Device implanted in Jason Silver’s

abdomen failed and required revision and removal surgeries.

70. At the time the SynchroMed® II Device implanted into Jason Silver’s abdomen

left the control of Medtronic, it was unreasonably dangerous due to Medtronic’s violations of the

Federal Food, Drug, and Cosmetic Act, and the regulations promulgated pursuant to it in one or

more of the following ways:

a. The SynchroMed® II Device was introduced or delivered for introduction into

interstate commerce as adulterated in violation of 21 U.S.C. §§ 331, 351(h) and

21 C.F.R. Part 820;

b. The SynchroMed® II Device was adulterated in interstate commerce in violation

of 21 U.S.C. §§ 331, 351 (h) and 21 C.F.R. Part 820;


27

c. The SynchroMed® II Device was received in interstate commerce adulterated

and was delivered for pay or otherwise, in violation of 21 U.S.C. §§ 331, 351(h)

and 21 C.F.R. Part 820; and

d. The SynchroMed® II Device implanted in Jason Silver was adulterated because

it was manufactured in deviation from the manufacturing specifications approved

by the FDA in Medtronic’s PMA application in violation of the Federal Food,

Drug, and Cosmetic Act.

71. At all times relevant hereto, federal law required Defendants to manufacture the

SynchroMed® II Device in compliance with federal specifications and requirements imposed

through the PMA process for the device, and in compliance with post-approval federal

regulations, including but not limited to those set out in 21 C.F.R. § 801, et seq., 21 C.F.R. 803,

et seq., 21 C.F.R. § 814, et seq., 21 C.F.R. § 806, et seq., 21 C.F.R. § 820, et seq., and 21 U.S.C.

§§ 351-352. Such regulations are promulgated to ensure a manufactured device is free from a

defective condition unreasonably dangerous to the consumer.

72. Jason Silver suffered injury due to his non-conforming, adulterated, and defective


73. As a result of Medtronic’s failure to use reasonable care in complying with

federal law in the manufacture of Jason Silver’s SynchroMed® II Device, Mr. Silver’s Device

was manufactured out of specification, was non-conforming, adulterated, and had the propensity

for failure and malfunction and did fail and malfunction.

74. As a foreseeable, direct and proximate result of Defendants’ negligence in

manufacturing Jason Silver’s SynchroMed® II Device, Mr. Silver experienced severe pain and

suffering which continues through present day and will continue into the future, a surgery to


28

explant his defective SynchroMed® II Device, extensive hospitalization and medical procedures,

and other damages compensable by law.

COUNT II FAILURE TO WARN




duties under federal law governing Plaintiff’s Device. Plaintiff’s state law claims are based

upon and arise from Defendants’ violation of and deviation from federal regulations regarding

Plaintiffs’ Device as set forth herein.

77. Defendants are medical device entities engaged in the design and/or research

and/or manufacture and/or production and/or testing and/or assembling and/or labeling and/or

packaging and/or distribution and/or sale and/or otherwise placing into the stream of commerce

various medical devices intended for human use, including the SynchroMed® II Device, which

is a surgically implanted device that delivers medication into the intrathecal space of patients for

the treatment of chronic pain, and as an alternative to oral pain medication.

78. At all times relevant hereto, Medtronic had a continuing duty under federal law

and under Pennsylvania law to monitor the SynchroMed® II Device placed into the stream of

commerce, to discover and report to the FDA any complaints about the product’s performance

and any adverse health consequences of which Medtronic became aware, and that are or may be

attributable to the product. (FD&C Act, Medical Device Reporting Title 21, Code of Federal

Regulations (C.F.R.), Part 803)) “[R]equires manufacturers, distributors, and initial distributors

of medical devices to establish, maintain a record of and report the result to FDA certain adverse

events that they receive from any source, and to establish and maintain reports.”


29

79. At all times relevant hereto, under Pennsylvania law, Defendants had a duty to

disclose to users and purchasers, including the FDA, of potentially dangerous risks involved in

their product’s use. Such duty imposes an obligation on Medtronic to timely inform the FDA

when Medtronic learned of the propensity for defects

80. Medtronic breached their duty under federal and Pennsylvania law, in that it:

a. Failed to report known problems with Devices;15

b. Failure to report consumer generated adverse events;

c. Failed to report under 21 CFR 803, a “malfunction” event for an adverse event;16

and

d. Failed to submit FDA-mandated Medical Device Reports (MDRs) within 30 days

of becoming aware that the SynchroMed® II Device caused or contributed to a

death or serious injury, under 21 C.F.R. § 803.50(a)(1), thereby resulting in the

devices being “misbranded.”17

81. Medtronic knew at all times before Jason Silver was implanted with his

SynchroMed® II Device that his Device was defective in that it would not deliver the

programmed rate of medication, yet it failed to inform the FDA of the danger.

82. Because Medtronic failed to comply with their duty under federal law, they

breached their “duty to use reasonable care” under Pennsylvania law to disclose material risks of

the SynchroMed® II Device to the FDA and the public, including Jason Silver. This duty

15 See Exhibit 3.

16 Id.

17 Id.


30

parallels Medtronic’s requirements under federal law to timely and properly report adverse

events and safety issues relating to the SynchroMed® II Device.

83. Had the FDA been properly and timely warned of the known problems and

defects associated with Jason Silver’s Device, Jason Silver and his medical providers would have

learned of the dangers and heeded that warning, thereby avoiding use of the Device.

84. As a foreseeable, direct and proximate result of Medtronic’s failure to warn, as set

forth above, about the defective condition of the SynchroMed® II Device, Jason Silver

experienced severe pain and suffering which continues through present day and will continue

into the future, a surgical procedure to explant his defective SynchroMed® II Device, extensive

hospitalization and medical procedures, and other damages compensable by law.

COUNT III NEGLIGENCE




duties under federal law governing Plaintiff’s Device. Plaintiff’s state law claims are based

upon and arise from Defendants’ violation of and deviation from federal regulations regarding

Plaintiffs’ Device as set forth herein.

87. Defendants, and each of them, are medical device entities engaged in the design

and/or research and/or manufacture and/or production and/or testing and/or assembling and/or

labeling and/or packaging and/or distribution and/or sale and/or otherwise placing into the stream

of commerce various medical devices intended for human use, including the SynchroMed® II

Device, which is a surgically implanted device that delivers medication into the intrathecal space

of patients for the treatment of chronic pain, and as an alternative to oral pain medication.


31

88. At all times relevant hereto, Defendants manufactured, distributed and sold Jason

Silver’s SynchroMed® II Device, comprising of a pump and catheter. Mr. Silver used his

SynchroMed® II Device as intended by the Medtronic.

89. Under Pennsylvania law, every manufacturer, including Medtronic has a duty to

use reasonable care to avoid foreseeable dangers in their products. Specifically, Medtronic at all

relevant times hereto had a duty to use reasonable care in the manufacturer, testing, monitoring,

inspection, assembly, and sale of Jason Silver’s SynchroMed® II Device. Such duties are

parallel to those imposed under federal law.

90. Federal law imposes post-market requirement on Medtronic, including those

found under 21 C.F.R. § 820, et seq., which promulgates Current Good Manufacturing Practices

(CGMPs). The quality control requirements of the CGMPs are designed to ensure Medtronic’s

products conform to manufacturing specifications, that non-conforming products do not reach

the market, and that problems with products in the field are properly monitored, tracked and

reported. The CGMPs require Medtronic to evaluate signals of unexpected or serious events of

injury in the field and report to the FDA when a device causes, or is suspected to cause, injury in

the field. A device that has been manufactured, monitored, packed, stored, inspected, or installed

in violation of this requirement is deemed to be adulterated. 21 C.F.R. § 351 (h). A manufacturer

is prohibited from introducing, delivering, or selling an adulterated device into interstate

commerce. 21 C.F.R. § 331(a),(k).

91. As a result of numerous FDA inspections from 2006-2013 to Medtronic’s

manufacturing plants in Minneapolis, Minnesota and Juncos Puerto Rico, as alleged herein, the

FDA determined the SynchroMed® II Device was “adulterated” and “misbranded” and thereby

violated specific CGMPs as outlined supra in paragraphs herein.


32

92. Medtronic violated their duty to comply with their obligations to manufacture

their SynchroMed® II Device in conformity with CGMPs and therefore could not ensure the

safety and effectiveness of the SynchroMed® II Device received by Jason Silver.

93. As a foreseeable, direct and proximate result of the Medtronic’s failure to use due

care to avoid foreseeable dangers in their SynchroMed® II Device, Jason Silver’s SynchroMed®

II Device was manufactured out of specification and was misbranded and adulterated in violation

of federal law.

94. As a further foreseeable, direct and proximate result of Medtronic’s failure to use

due care to avoid foreseeable dangers in their SynchroMed® II Device, Jason Silver’s

nonconforming Device failed to deliver medication into his intrathecal space at the programmed

rate, causing severe pain and suffering which continues through present day and will continue

into the future, a surgical procedure to explant the defective SynchroMed® II Device, extensive

hospitalization and medical procedures, and other damages compensable by law.

COUNT V BREACH OF EXPRESS WARRANTY

95. Plaintiff incorporates by reference as if fully set forth herein, each and every


96. At all times relevant hereto, Medtronic expressly warranted and promised by way

of written literature, advertisements, and/or other documents and/or promotional materials

directed to Jason Silver and his medical providers, that despite the significant cost difference in

therapy, the use of an implanted SynchroMed® II Device designed to deliver medication to the

intrathecal space was a superior and safer method than oral medication and/or alternative means

of therapy to treat his muscle spasticity.


33

97. Jason Silver and his medical providers received, heard, and/or read Medtronic’s

express warranties that the SynchroMed® II Device conformed to FDA regulations and

specifications, and was safe, effective, and fit and proper for its intended uses and foreseeable

uses.

98. Based upon Medtronic’s representations of the significant benefits of the

SynchroMed® II Device as compared to other forms of pain medication delivery, Jason Silver

purchased and underwent surgery for implantation of the SynchroMed® II Device.

99. Jason Silver and his medical providers received, heard, and/or read Medtronic’s

express warranties that the SynchroMed® II Device conformed to FDA regulations and

specifications, and was safe, effective, and fit and proper for its intended uses and foreseeable

uses.

100. Jason Silver and his medical providers relied upon Medtronic’s express warranties

that the SynchroMed® II Device conformed to FDA regulations and specifications, and was safe,

effective, and fit and proper for its intended uses and foreseeable uses, when in fact it was

manufactured in violation of federal regulations and specifications and was unsafe and unfit for

such uses.

101. Defendants breached their express warranties because the warranty and

representations were untrue in that:

a. The FDA had determined that the Medtronic SynchroMed® II Device implanted

in Jason Silver was manufactured in violation of federal regulations and

specifications, including CGMPs;

b. The FDA violations of CGMPs committed by Medtronic meant that Medtronic

was unable to confirm that the SynchroMed® II Device implanted in Jason Silver


34

was safe and effective, fully conformed to specifications, and was free of defects

that could lead to malfunctions having the potential to cause or contribute to

serious bodily injury; and

c. The FDA had determined that the SynchroMed® II Device implanted in Jason

Silver was manufactured at a time when SynchroMed® II Devices were labeled

“adulterated” and “misbranded.”

102. The implanted SychroMed® II Device’s intrathecal infusion delivery of pain

medication is not a superior method to oral pain medication or alternative therapy.

103. As a result of the aforementioned breach of their express warranties by

Medtronic, Jason Silver experienced severe pain and suffering which continues through present

day and will continue into the future, a surgical procedure to explant his defective SynchroMed®

II Device, extensive hospitalization and medical procedures, and other damages compensable by

law.

COUNT VI BREACH OF IMPLIED WARRANTIES

104. Plaintiff incorporates by reference as if fully set forth herein, each and every


105. Prior to purchasing the Medtronic’s SynchroMed® II Device, Defendants

provided Jason Silver and his physicians written advertising materials (which were not part of

the pre-approval process) describing the SynchroMed® II Device as a better alternative to

receiving oral medications in that it was:

a. “a safer way to receive pain medication”;

b. “Help you rejoin life so you can get back to the activities and people that make

you happiest”;


35

c. “allows you to ‘Tame your Pain’”;

d. “reduce your need for oral medications”;

e. “provide peace of mind knowing that you’ve selected a drug delivery system that

was manufactured by Medtronic . . .”;

f. “give reassurance because only Medtronic offers a programmable drug delivery

system that is FDA approved for MRI scans . . .”;

g. “drug delivery therapy from Medtronic is proven safe and effective therapy”;

h. “Medtronic drug delivery therapy has been tested, is shipped sterile, and is FDA

approved”; and

i. “More doctors trust Medtronic than any other company offering drug delivery

therapy.”

106. Jason Silver and his physicians relied on the written advertisements of Medtronic

related to the SynchroMed® II Device, leading to the implantation of the Device into Jason

Silver’s body.

107. The SynchroMed® II Device implanted in Jason Silver failed to perform its

essential purpose, which was to deliver programmed pain medication into his intrathecal space.

108. Jason Silver’s SynchroMed® II Device was not reasonably fit for ordinary use or

use in the manner ordinarily contemplated in that it failed to deliver medication to Mr. Silver

according to its programmed rate. Accordingly, Medtronic breached its implied warranty of

merchantability with respect to Jason Silver’s SynchroMed® II Device.

109. At the time and place that Jason Silver purchased and used the SynchroMed® II

Device, Mr. Silver relied upon Medtronic’s implied warranties, not knowing that Medtronic

knew, that in fact the SynchroMed® II Device was unfit and unsafe for its ordinary use, and had


36

been found by the FDA to be “adulterated” and “misbranded” in that it was not manufactured,

and/or packaged, and/or labeled in accordance with FDA regulations, did not perform in

accordance with approved specifications, and was therefore not safe nor effective for the

intended, known, or foreseeable uses, nor of merchantable quality, as warranted by Medtronic.

110. As a result of Medtronic’s aforementioned breach of their implied warranties,

Jason Silver, after purchasing and being implanted with, and utilizing Medtronic’s non-

conforming, defective products, experienced severe pain and suffering which continues through

present day and will continue into the future, underwent a surgical procedure to explant the

defective SynchroMed® II Device, and suffered extensive hospitalization and medical

procedures.

COUNT VII NEGLIGENT MISREPRESENTATION

111. Plaintiff incorporates by references, as if fully set forth herein, each and every


112. At all times relevant hereto, Medtronic had a duty under Pennsylvania law to

advertise and represent correct information regarding the SynchroMed® II Device, as such

information involves public welfare and safety.

113. At all times relevant hereto, Defendants negligently misrepresented to Jason

Silver and his medical providers that the SynchroMed® II Device implanted in Mr. Silver was

safe and effective, despite knowing that the SynchroMed® II Device was defective and capable

of causing the injuries described herein.

114. Defendants made the aforesaid representations with no reasonable ground for

believing them to be true when Defendants possessed data showing the SynchroMed® II Device

to be defective and dangerous when used in the intended manner.


37

115. The aforesaid representations were made to the medical providers prescribing the

SynchroMed® II Device prior to the dates prescribed to Jason Silver and used by Mr. Silver’s

medical providers with the intent that Jason Silver and his medical providers rely upon such

misrepresentations about the safety and efficacy of the SynchroMed® II Device.

116. Defendants failed to use reasonable care or competence in obtaining the

information or communicating it to Jason Silver and his medical providers.

117. Jason Silver and his medical providers reasonably and justifiably relied upon such

representations provided by Defendants that the SynchroMed® II Device was safe for use for the

prescribed and intended purposes.

118. Representations and communication by Defendants to Jason Silver and his

medical providers were false, and thereby caused Jason Silver’s injuries described herein,

harming Mr. Silver as a result of the false representations of Defendants.

COUNT VIII VIOLATION OF PENNSYLVANIA’S UNFAIR TRADE PRACTICES AND CONSUMER

PROTECTION LAW

119. Plaintiff incorporates by references, as if fully set forth herein, each and every


120. By reason of the conduct alleged herein, Defendants violated Pennsylvania’s

Unfair Trade Practices and Consumer Protection Law (UTPCPL), 73 P.S. 18§ 201-1, et seq., by

engaging in fraudulent and deceptive conduct which created a likelihood of confusion and/or

misunderstanding.

121. At all times relevant hereto, Defendants knowingly and intentionally induced

Jason Silver to use the SynchroMed II Device through the use of false and or/misleading

representations and statements.


38

122. The SynchroMed II Device failed to perform as represented and, in fact, was

unsafe.

123. Defendants induced Jason Silver and his physicians, through the use of false

and/or misleading advertising, representations, and statements, as described above, to use and/or

implant the SynchroMed II Device, which Defendants manufactured and/or distributed and sold,

all in violation of the UTPCPL, which proscribes, among other things:

a. Engaging in unfair trade practices as defined in the statute by making false and

misleading oral and written statements that have the capacity, tendency, or effect

of deceiving or misleading consumers;

b. Engaging in unfair trade practices as defined in the statute by making

representations that its SynchroMed II Device had an approval, characteristic, use,

or benefit which it did not have, including but not limited to statements

concerning the consequences of the use of the SynchroMed II Device;

c. Engaging in unfair trade practices as defined in the statute by failing to state

material facts, the omission of which deceived or tended to deceive, including but

not limited to facts relating to the health consequences of the use of the

SynchroMed II Device; and

d. Engaging in unfair trade practices as defined in the statute through deception,

fraud, misrepresentation, and knowing concealment, suppression, and omission of

material facts with the intent that consumers rely upon the same in connection

with the use and continued use of the SynchroMed II Device.

124. As a foreseeable, direct and proximate result of Defendants’ statutory violations,

Jason Silver had the SynchroMed II Device implanted, which he would not have had implanted


39

had Defendants not issued false and/or misleading advertisements, representations, and

statements.

125. By reason of such violations and pursuant to the laws and regulations of this state,

Plaintiff is entitled to recover all of the monies paid for the products; to be compensated for the

cost of medical care arising out of the use of the SynchroMed II Device; together with any and

all actual damages recoverable under the law including, but not limited to, past medical

expenses, past pain and suffering, disability, and emotional distress.

126. In addition, Plaintiff is entitled to recover fees and disbursements, including costs

of investigation, reasonable attorneys’ fees, and any other equitable relief as determined by this

Court.

V. PUNITIVE DAMAGES

127. Defendants, through their agents, committed the acts alleged herein outrageously,

maliciously, willfully, because of Defendants’ evil motive or reckless indifference to the rights

of others, including Jason Silver. Defendants received information that long term use of

SynchroMed® II Device increased the likelihood of drug under- and overdose, leading to

respiratory depression, coma or death and potential for electrical shorting, leading to a loss of or

reduction in therapy, resulting in serious adverse health consequences including death and other

injuries, but despite this information continued to intentionally and falsely represent that using

SynchroMed® II Device was safe. Defendants failed to issue warnings until the incident rate of

injury was so high. Even after that time, Defendants downplayed the adverse effects of the

SynchroMed® II Device, and misinformed and continued to promote the SynchroMed® II

Device to the public. Defendants did so in order to preserve the lucrative and growing market

they had carefully built with deception. The failure to inform doctors and their patients of


40

material risks of the SynchroMed® II Device was intentional. Defendants acted with greed and

other improper and evil motives amounting to malice, and in conscious disregard of Jason

Silver’s rights. The acts taken toward Mr. Silver were carried out in a deliberate and intentional

or grossly reckless manner with malice and without regard of the likelihood that Defendants’

products would injure and damage Jason Silver and others. Plaintiff is entitled to recover

punitive damages from Defendants in an amount according to proof.

VI. PRAYER FOR RELIEF

Plaintiff hereby requests a trial by jury on all claims and issues so triable.

WHEREFORE, Plaintiff demands judgment against Defendants in an amount of damages in

excess of seventy-five thousand dollars ($75,000.00), individually, jointly, severally, and in the

alternative, including:

1. Awarding actual damages to Plaintiff incidental to the purchase and use of the products at

issue in an amount to be determined at trial;

2. Awarding the past and future costs of treatment for Plaintiff’s injuries caused by the

products at issue in an amount to be determined at trial;

3. Awarding damages for Plaintiff’s physical pain and suffering in an amount to be

determined at trial;

4. Awarding damages for Plaintiff’s mental and emotional anguish in an amount to be

determined at trial;

5. Awarding damages for Plaintiff’s loss of earnings and future earning capacity;

6. Awarding pre-judgment and post-judgment interest to Plaintiff;

7. Awarding injunctive relief, including disgorgement of all profits made from and monies

from and monies paid for the products at issue in an amount to be determined at trial;


41

8. Awarding punitive and/or exemplary damages;

9. Awarding the costs and expenses of this litigation incurred by Plaintiff;

10. Awarding reasonable attorneys’ fees and costs to Plaintiff as provided by law;

11. Awarding civil penalties for statutory violations as claimed above; and

12. Any other further relief in law or equity that this Court deems appropriate, necessary,

just, and proper.

Respectfully submitted by:

/s/ Kevin Haverty

Esther E. Berezofsky, Esq. (PA #50151) Kevin Haverty, Esq. (PA # 65789) WILLIAMS CUKER BEREZOFSKY, LLC 1515 Market Street, Suite 1300 Philadelphia, PA 19102 Telephone: (215) 557-0099 Facsimile: (215) 557-0673 Email: [email protected]

[email protected]

Gale D. Pearson, Esq. PEARSON, RANDALL, & SCHUMACHER, P.A. 310 Fourth Avenue South, Suite 5010 Minneapolis, Minnesota 55415 Telephone: (612) 767-7500 Facsimile: (612) 767-7501 Email: [email protected] Michelle A. Parfitt, Esq. Drew LaFramboise, Esq. ASHCRAFT & GEREL, LLP 4900 Seminary Road, Suite 650 Alexandria, Virginia 22311 Telephone: (703) 931-5500 Facsimile: (703) 820-1656 Email: [email protected] [email protected] ATTORNEYS FOR PLAINTIFFS


JS 44 (Rev. 0 /16) CIVIL COVER SHEETThe JS 44 civil cover sheet and the information contained herein neither replace nor supplement the filing and service of pleadings or other papers as required by law, except asprovided by local rules of court. This form, approved by the Judicial Conference of the United States in September 1974, is required for the use of the Clerk of Court for thepurpose of initiating the civil docket sheet. (SEE INSTRUCTIONS ON NEXT PAGE OF THIS FORM.)

I. (a) PLAINTIFFS DEFENDANTS

(b) County of Residence of First Listed Plaintiff County of Residence of First Listed Defendant(EXCEPT IN U.S. PLAINTIFF CASES) (IN U.S. PLAINTIFF CASES ONLY)

NOTE: IN LAND CONDEMNATION CASES, USE THE LOCATION OF THE TRACT OF LAND INVOLVED.

(c) Attorneys (Firm Name, Address, and Telephone Number) Attorneys (If Known)

II. BASIS OF JURISDICTION (Place an “X” in One Box Only) III. CITIZENSHIP OF PRINCIPAL PARTIES (Place an “X” in One Box for Plaintiff(For Diversity Cases Only) and One Box for Defendant)

1 U.S. Government 3 Federal Question PTF DEF PTF DEFPlaintiff (U.S. Government Not a Party) Citizen of This State 1 1 Incorporated or Principal Place 4 4

of Business In This State

2 U.S. Government 4 Diversity Citizen of Another State 2 2 Incorporated and Principal Place 5 5Defendant (Indicate Citizenship of Parties in Item III) of Business In Another State

Citizen or Subject of a 3 3 Foreign Nation 6 6 Foreign Country

IV. NATURE OF SUIT (Place an “X” in One Box Only)CONTRACT TORTS FORFEITURE/PENALTY BANKRUPTCY OTHER STATUTES

110 Insurance PERSONAL INJURY PERSONAL INJURY 625 Drug Related Seizure 422 Appeal 28 USC 158 375 False Claims Act120 Marine 310 Airplane 365 Personal Injury - of Property 21 USC 881 423 Withdrawal 376 Qui Tam (31 USC 130 Miller Act 315 Airplane Product Product Liability 690 Other 28 USC 157 3729(a))140 Negotiable Instrument Liability 367 Health Care/ 400 State Reapportionment150 Recovery of Overpayment 320 Assault, Libel & Pharmaceutical PROPERTY RIGHTS 410 Antitrust

& Enforcement of Judgment Slander Personal Injury 820 Copyrights 430 Banks and Banking151 Medicare Act 330 Federal Employers’ Product Liability 830 Patent 450 Commerce152 Recovery of Defaulted Liability 368 Asbestos Personal 840 Trademark 460 Deportation

Student Loans 340 Marine Injury Product 470 Racketeer Influenced and (Excludes Veterans) 345 Marine Product Liability LABOR SOCIAL SECURITY Corrupt Organizations

153 Recovery of Overpayment Liability PERSONAL PROPERTY 710 Fair Labor Standards 861 HIA (1395ff) 480 Consumer Credit of Veteran’s Benefits 350 Motor Vehicle 370 Other Fraud Act 862 Black Lung (923) 490 Cable/Sat TV

160 Stockholders’ Suits 355 Motor Vehicle 371 Truth in Lending 720 Labor/Management 863 DIWC/DIWW (405(g)) 850 Securities/Commodities/190 Other Contract Product Liability 380 Other Personal Relations 864 SSID Title XVI Exchange195 Contract Product Liability 360 Other Personal Property Damage 740 Railway Labor Act 865 RSI (405(g)) 890 Other Statutory Actions196 Franchise Injury 385 Property Damage 751 Family and Medical 891 Agricultural Acts

362 Personal Injury - Product Liability Leave Act 893 Environmental Matters Medical Malpractice 790 Other Labor Litigation 895 Freedom of Information

REAL PROPERTY CIVIL RIGHTS PRISONER PETITIONS 791 Employee Retirement FEDERAL TAX SUITS Act210 Land Condemnation 440 Other Civil Rights Habeas Corpus: Income Security Act 870 Taxes (U.S. Plaintiff 896 Arbitration220 Foreclosure 441 Voting 463 Alien Detainee or Defendant) 899 Administrative Procedure230 Rent Lease & Ejectment 442 Employment 510 Motions to Vacate 871 IRS—Third Party Act/Review or Appeal of240 Torts to Land 443 Housing/ Sentence 26 USC 7609 Agency Decision245 Tort Product Liability Accommodations 530 General 950 Constitutionality of290 All Other Real Property 445 Amer. w/Disabilities - 535 Death Penalty IMMIGRATION State Statutes

Employment Other: 462 Naturalization Application446 Amer. w/Disabilities - 540 Mandamus & Other 465 Other Immigration

Other 550 Civil Rights Actions448 Education 555 Prison Condition

560 Civil Detainee - Conditions of Confinement

V. ORIGIN (Place an “X” in One Box Only)1 Original

Proceeding2 Removed from

State Court 3 Remanded from

Appellate Court4 Reinstated or

Reopened 5 Transferred from

Another District(specify)

6 MultidistrictLitigation -Transfer

8 Multidistrict Litigation -

Direct File

VI. CAUSE OF ACTIONCite the U.S. Civil Statute under which you are filing (Do not cite jurisdictional statutes unless diversity):

Brief description of cause:

VII. REQUESTED INCOMPLAINT:

CHECK IF THIS IS A CLASS ACTIONUNDER RULE 23, F.R.Cv.P.

DEMAND $ CHECK YES only if demanded in complaint:JURY DEMAND: Yes No

VIII. RELATED CASE(S)IF ANY (See instructions):

JUDGE DOCKET NUMBERDATE SIGNATURE OF ATTORNEY OF RECORD

FOR OFFICE USE ONLY

RECEIPT # AMOUNT APPLYING IFP JUDGE MAG. JUDGE

IN EXCESS OF

Jason Silver

Adams

Kevin Haverty, Esq., Williams Cuker Berezofsky, LLC1515 Market Street, Suite 1300, Phila., PA 19102(215) 557-0099

Medtronic, Inc., Medtronic Neuromodulation, a division of Medtronic,Inc., Medtronic Puerto Rico Operations, Inc., and Medtronic Logistics,LLC

Hennepin, MN

28 U.S.C. § 1332

Injuries resulting from a malfunctioning and defective Medtronic SynchroMed® II Device

75,000.00

08/12/2016 /s/Kevin Haverty

Case 1:16-cv-01682-JEJ Document 1-1 Filed 08/12/16 Page 1 of 2

JS 44 Reverse (Rev. 0 /16)

INSTRUCTIONS FOR ATTORNEYS COMPLETING CIVIL COVER SHEET FORM JS 44Authority For Civil Cover Sheet

The JS 44 civil cover sheet and the information contained herein neither replaces nor supplements the filings and service of pleading or other papers asrequired by law, except as provided by local rules of court. This form, approved by the Judicial Conference of the United States in September 1974, isrequired for the use of the Clerk of Court for the purpose of initiating the civil docket sheet. Consequently, a civil cover sheet is submitted to the Clerk ofCourt for each civil complaint filed. The attorney filing a case should complete the form as follows:

I.(a) Plaintiffs-Defendants. Enter names (last, first, middle initial) of plaintiff and defendant. If the plaintiff or defendant is a government agency, useonly the full name or standard abbreviations. If the plaintiff or defendant is an official within a government agency, identify first the agency and then the official, giving both name and title.

(b) County of Residence. For each civil case filed, except U.S. plaintiff cases, enter the name of the county where the first listed plaintiff resides at the time of filing. In U.S. plaintiff cases, enter the name of the county in which the first listed defendant resides at the time of filing. (NOTE: In land condemnation cases, the county of residence of the "defendant" is the location of the tract of land involved.)

(c) Attorneys. Enter the firm name, address, telephone number, and attorney of record. If there are several attorneys, list them on an attachment, notingin this section "(see attachment)".

II. Jurisdiction. The basis of jurisdiction is set forth under Rule 8(a), F.R.Cv.P., which requires that jurisdictions be shown in pleadings. Place an "X"in one of the boxes. If there is more than one basis of jurisdiction, precedence is given in the order shown below.United States plaintiff. (1) Jurisdiction based on 28 U.S.C. 1345 and 1348. Suits by agencies and officers of the United States are included here.United States defendant. (2) When the plaintiff is suing the United States, its officers or agencies, place an "X" in this box.Federal question. (3) This refers to suits under 28 U.S.C. 1331, where jurisdiction arises under the Constitution of the United States, an amendmentto the Constitution, an act of Congress or a treaty of the United States. In cases where the U.S. is a party, the U.S. plaintiff or defendant code takesprecedence, and box 1 or 2 should be marked.Diversity of citizenship. (4) This refers to suits under 28 U.S.C. 1332, where parties are citizens of different states. When Box 4 is checked, thecitizenship of the different parties must be checked. (See Section III below; NOTE: federal question actions take precedence over diversitycases.)

III. Residence (citizenship) of Principal Parties. This section of the JS 44 is to be completed if diversity of citizenship was indicated above. Mark thissection for each principal party.

IV. Nature of Suit. Place an "X" in the appropriate box. If the nature of suit cannot be determined, be sure the cause of action, in Section VI below, issufficient to enable the deputy clerk or the statistical clerk(s) in the Administrative Office to determine the nature of suit. If the cause fits more thanone nature of suit, select the most definitive.

V. Origin. Place an "X" in one of the seven boxes.Original Proceedings. (1) Cases which originate in the United States district courts.Removed from State Court. (2) Proceedings initiated in state courts may be removed to the district courts under Title 28 U.S.C., Section 1441.When the petition for removal is granted, check this box.Remanded from Appellate Court. (3) Check this box for cases remanded to the district court for further action. Use the date of remand as the filingdate.Reinstated or Reopened. (4) Check this box for cases reinstated or reopened in the district court. Use the reopening date as the filing date.Transferred from Another District. (5) For cases transferred under Title 28 U.S.C. Section 1404(a). Do not use this for within district transfers ormultidistrict litigation transfers.Multidistrict Litigation – Transfer. (6) Check this box when a multidistrict case is transferred into the district under authority of Title 28 U.S.C.Section 1407.Multidistrict Litigation – Direct File. (8) Check this box when a multidistrict case is filed in the same district as the Master MDL docket.PLEASE NOTE THAT THERE IS NOT AN ORIGIN CODE 7. Origin Code 7 was used for historical records and is no longer relevant due tochanges in statue.

VI. Cause of Action. Report the civil statute directly related to the cause of action and give a brief description of the cause. Do not cite jurisdictionalstatutes unless diversity. Example: U.S. Civil Statute: 47 USC 553 Brief Description: Unauthorized reception of cable service

VII. Requested in Complaint. Class Action. Place an "X" in this box if you are filing a class action under Rule 23, F.R.Cv.P.Demand. In this space enter the actual dollar amount being demanded or indicate other demand, such as a preliminary injunction.Jury Demand. Check the appropriate box to indicate whether or not a jury is being demanded.

VIII. Related Cases. This section of the JS 44 is used to reference related pending cases, if any. If there are related pending cases, insert the docketnumbers and the corresponding judge names for such cases.

Date and Attorney Signature. Date and sign the civil cover sheet.


EXHIBIT 1


UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MINNESOTA

Civil No. 15 - 2168

UNITED STATES OF AMERICA, ) )

Plaintiff ) )

v. ) ) COMPLAINT FOR

MEDTRONIC INC., a corporation, and ) PERMANENT INJUNCTION S. OMAR ISHRAK and ) THOMAS M. TEFFT, individuals, )

) )

Defendants. ) _________________________________)

INTRODUCTION

Plaintiff, the United States of America, by its undersigned attorneys, respectfully

represents to this Court as follows:

1. This statutory injunction proceeding is brought under the Federal Food,

Drug, and Cosmetic Act (the "Act"), 21 U.S.C. § 332(a), to enjoin Medtronic Inc.

(“Medtronic”), a corporation, and S. Omar Ishrak, and Thomas M. Tefft, individuals

(hereinafter, collectively, “Defendants”) from violating:

A. 21 U.S.C. § 331(a), by introducing or delivering for introduction into

interstate commerce, or causing the introduction or delivery for introduction into

interstate commerce, articles of devices, as defined by 21 U.S.C. § 321(h), that are

adulterated within the meaning of the Act, 21 U.S.C. § 351(h), in that the methods used

in, or the facilities or controls used for, their manufacture, packing, storage, and

CASE 0:15-cv-02168 Document 1 Filed 04/27/15 Page 1 of 10Case 1:16-cv-01682-JEJ Document 1-2 Filed 08/12/16 Page 2 of 11

2

installation are not in conformity with current good manufacturing practice requirements

prescribed at 21 C.F.R. Part 820;

B. 21 U.S.C. § 331(k), by causing devices to become adulterated within

the meaning of 21 U.S.C. § 351(h), as described in paragraph A above, while such

devices are held for sale after shipment in interstate commerce.

JURISDICTION AND VENUE

2. This Court has jurisdiction under 21 U.S.C. § 332(a) and 28 U.S.C. §§ 1331

and 1345.

3. Venue in this District is proper pursuant to 28 U.S.C. § 1391(b) and (c).

DEFENDANTS

4. Medtronic is incorporated under the laws of Minnesota. Medtronic

Neuromodulation (“Medtronic Neuro”), a business unit of Medtronic, manufactures

medical devices, including but not limited to, SynchroMed II implantable infusion

pumps. The headquarters of Medtronic Neuro is located at 7000 Central Ave. NE,

Minneapolis, MN 55432, and its manufacturing facility is located at 53rd Avenue, NE,

Columbia Heights, MN 55421.

5. S. Omar Ishrak is Medtronic’s Chairman and CEO. He is the most

responsible person at the firm, and oversees the firm's product development, product

management, and international relations and sales. He performs his duties at 710

Medtronic Parkway, Minneapolis, MN 55432.

6. Thomas M. Tefft is the Senior Vice President of Medtronic, and the

President of Medtronic Neuro. He is the most responsible person at Medtronic Neuro,


3

and oversees the business unit’s product development, research, regulatory compliance

and marketing. He performs his duties at 7000 Central Ave. NE, Minneapolis, MN

55432.

7. Defendants have been, and are now, manufacturing and distributing in

interstate commerce various articles of devices, as defined by 21 U.S.C. § 321(h),

including, but not limited to, SynchroMed II implantable infusion pumps, the subject of

this injunction.

8. Defendants’ products are devices, within the meaning of 21 U.S.C. §

321(h), in that they are intended to affect the structure or any function of the body of

man.

LEGAL STANDARDS

9. A device must be manufactured, packed, stored, and installed in conformity

with good manufacturing practice to ensure its safety and effectiveness. 21 U.S.C.

§ 360j(f). The statutory good manufacturing practice requirement is set out in the quality

system ("QS") regulation for devices, 21 C.F.R. Part 820. A device that has been

manufactured, packed, stored, or installed in violation of this requirement is deemed to be

adulterated. 21 U.S.C. § 351(h).

10. The introduction or delivery for introduction into interstate commerce of an

adulterated article of device is a violation of the Act, 21 U.S.C. § 331(a).

11. The adulteration of a device while it is held for sale after shipment in

interstate commerce constitutes a violation of the Act, 21 U.S.C. § 331(k).


4

APRIL 2013 INSPECTION

12. FDA inspected Medtronic Neuro’s manufacturing facility on February 14 –

April 3, 2013 (“April 2013 inspection”). During the April 2013 inspection, the FDA

investigators documented numerous violations of the QS regulation at Medtronic Neuro.

Many of these violations related directly to the manufacture of the SynchroMed II

implantable infusion pump. FDA investigators observed the following violations of the

QS regulation set forth in 21 C.F.R. Part 820:

A. Defendants fail to establish and maintain adequate design validation

procedures to ensure that devices conform to defined user needs and intended uses, to

complete proper risk analysis, and to document the results of the validation, in violation

of 21 C.F.R. § 820.30(g);

B. Defendants fail to establish and maintain adequate procedures to

include requirements for identifying the action(s) needed to correct and prevent

recurrence of nonconforming product and other quality problems, in violation of 21

C.F.R. § 820.100(a)(3);

C. Defendants fail to establish and maintain adequate procedures to

include requirements for verifying or validating the corrective and preventive action to

ensure that such action is effective and does not adversely affect the finished device, in

violation of 21 C.F.R. § 820.100(a)(4);

D. Defendants fail to establish and maintain procedures for

implementing corrective and preventive action, in violation of 21 C.F.R. § 820.100(a);


5

E. Defendants fail to establish and maintain procedures for verifying

the device design, in violation of 21 C.F.R. § 820.30(f);

F. Defendants fail to establish and maintain procedures for the

identification, documentation, validation or where appropriate verification, review, and

approval of design changes before their implementation, in violation of 21 C.F.R.

§ 820.30(i); and

G. Defendants fail to establish and maintain procedures to control

product that does not conform to specified requirements, in violation of 21 C.F.R.

§ 820.90(a).

PRIOR INSPECTIONS

13. FDA inspected Medtronic Neuro’s facilities previously in May 2012,

January 2011, January 2007, and June 2006. At these inspections, FDA repeatedly

observed and documented violations of the QS regulations similar to those cited above

during the April 2013 inspection, including, but not limited to, violations involving:

design controls (21 C.F.R. § 820.30) and corrective and preventive action (21 C.F.R.

§ 820.100).

14. At the conclusion of each of the prior inspections, the FDA investigators

issued a Form FDA 483 detailing Defendants' numerous violations of the Act to

Defendants, and discussed the documented observations with them. Defendants

promised corrections at the conclusion of each inspection.


6

PRIOR NOTICE OF VIOLATIONS

15. Defendants are well aware that their practices violate the Act. FDA has

repeatedly warned Defendants, both orally and in writing, about their violative conduct,

and has emphasized the importance of Defendants' compliance with the Act.

16. FDA issued a Warning Letter dated July 17, 2012 to Defendants, following

the May 2012 inspection of the Medtronic Neuro facility. The letter discussed the QS

violations involving corrective and preventive actions and complaint handling (21 C.F.R.

§ 820.198) observed at the inspection. The letter also warned Defendants that further

enforcement actions, including injunction, could occur if they did not correct the

violations.

17. Defendants also received Warning Letters, dated July 3, 2007 and August

29, 2006, following the January 2007 and June 2006 inspections. These letters also

addressed the numerous QS violations, including but not limited to design controls and

corrective and preventive action, observed during the inspections and warned of further

enforcement actions if corrections were not made.

18. Representatives of Medtronic also attended a meeting with FDA’s Center

for Devices and Radiological Health and Minneapolis District Office on January 31,

2013. At this meeting, Defendants stated that they were aware of the violations at their

facilities and were taking steps to correct them.

19. At the conclusion of each of FDA's inspections of the firm, the FDA

investigators issued a Form FDA 483 detailing Defendants' various violations of the Act


7

to a responsible individual at the firm and discussed the documented observations with

the recipient.

20. Defendants made promises to correct their violations in written responses to

the April 2013 inspection, dated April 24, and several follow-up responses, detailing

how and when the corrections promised in the April 24 letter had been made. None of

these responses contained adequate evidence that Defendants have corrected their

deviations.

21. Based on Defendants' conduct, Plaintiff believes that, unless restrained by

order of this Court, Defendants will continue to violate 21 U.S.C. §§ 331(a) and (k).

WHEREFORE, Plaintiff prays:

I. That Defendants and each of their directors, officers, agents,

representatives, employees, attorneys, successors, and assigns, and any and all persons in

active concert or participation with any of them, be permanently restrained and enjoined

pursuant to 21 U.S.C. § 332(a) from directly or indirectly:

A. violating 21 U.S.C. § 331(a), by introducing or delivering for

introduction into interstate commerce, or causing the introduction or delivery for

introduction into interstate commerce, any article of device that is adulterated within the

meaning of 21 U.S.C. § 351(h); or

B. violating 21 U.S.C. § 331(k), by causing any article of device to

become adulterated within the meaning of 21 U.S.C. § 351(h) while such devices are held

for sale after shipment in interstate commerce.


8

II. That the Court order Defendants and each of their directors, officers,

agents, representatives, employees, attorneys, successors, and assigns, and any and all

persons in active concert or participation with any of them, to cease directly and

indirectly manufacturing, packing, labeling, and distributing (domestically and

internationally) SynchroMed II implantable infusion pumps at or from its Medtronic

Neuro facilities, unless and until Defendants' methods, facilities, and controls used to

manufacture, process, pack, label, hold, and distribute the SynchroMed II implantable

infusion pumps are established, operated, and administered in compliance with 21 U.S.C.

§ 360j(f)(1) and the Quality System regulation prescribed in 21 C.F.R. Part 820, and in a

manner that has been found acceptable to FDA; and

III. That the Court authorize FDA, pursuant to this injunction, to inspect

Defendants' Medtronic Neuro facility to ensure continuing compliance with the terms of

this injunction, with the costs of such inspections to be borne by Defendants at the rates

prevailing at the time the inspections are performed.


9

IV. That Plaintiff be granted judgment for its costs herein, and that this Court

grant such other and further relief as it deems just and proper.

ANDREW M. LUGER United States Attorney s/ Chad A. Blumenfield CHAD BLUMENFIELD Assistant U.S. Attorney Attorney ID 387296 600 Courthouse 300 South Fourth St. Minneapolis, MN 55415 Ross S. Goldstein Trial Attorney Consumer Protection Branch U.S. Department of Justice Civil Division P.O. Box 386 Washington, DC 20044 OF COUNSEL: WILLIAM B. SCHULTZ Acting General Counsel ELIZABETH DICKINSON Associate General Counsel Food and Drug Division ANNAMARIE KEMPIC Deputy Chief Counsel, Litigation


10

TARA BOLAND Associate Chief Counsel United States Department of Health and Human Services Office of the General Counsel 10903 New Hampshire Ave. Silver Spring, MD 20993-0002 (301) 796-8549


EXHIBIT 2


Archived ContentThe content on this page is provided for reference purposes only. This content has notbeen altered or updated since it was archived.

Search Archive

Medtronic, Inc. 29Aug06

Department of Health and Human ServicesPublic Health Service Food and DrugAdministration

Minneapolis District OfficeCentral Region212 Third Avenue SouthMinneapolis, MN 55401Telephone: (612) 7587133FAX: (612) 3344142

August 29, 2006WARNING LETTER

CERTIFIED MAILRETURN RECEIPT REQUESTED

Refer to MIN 06 35Arthur D . Collins, Jr.Chairman of the Board and Chief Executive OfficerMedtronic, Inc .710 Medtronic ParkwayMinneapolis, MN 55432Dear Mr. Collins:During a May 18 June 22, 2006, inspection of your establishment, Medtronic Neurological, located at 800 53rd Avenue NE, Minneapolis, MN 55421, our investigators determined that your firm manufacturesimplantable drug infusion and neurostimulation products to treat pain, movement disorders, and othermedical conditions. These products are devices as defined by Section 201(h) of the Federal Food, Drug,and Cosmetic Act (the Act) [21 U.S.C. 321(h)] because they are intended for use in the diagnosis ofdisease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intendedto affect the structure or function of the body.This inspection revealed that these devices are adulterated under Section 501(h) of the Act [21 U.S.C.351(h)], in that the methods used in, or the facilities or controls used for, their manufacture, packing,storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP)requirements for medical devices which are set forth in the Quality System regulation, found at Title 21,Code of Federal Regulations (CFR), Part 820. Significant deviations include, but are not limited to, thefollowing:1. Failure to implement procedures to ensure that a device's design input requirements are appropriateand address its intended use, including user/patient needs, as required by 21 CFR 820.30(c). Design inputwork for the 8731 Intrathecal Catheter has not resulted in development of a complete design specification

Inspections, Compliance, Enforcement, and Criminal InvestigationsHome Inspections, Compliance, Enforcement, and Criminal Investigations Compliance Actions and Activities WarningLetters 2006


http://www.fda.gov/default.htm


http://www.fda.gov/ICECI/default.htm

http://www.fda.gov/ICECI/EnforcementActions/default.htm

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2006/default.htm

for the Platinum/ Iridium (Pt/Ir) catheter tip bond. (For more detail on this deviation, see FDA483observation # 1 from the May 18 June 22, 2006, inspection. Copy of FDA483 attached.)2 . Failure to conduct design validation using production units or their equivalents, as required by 21 CFR820.30(g). Design validation testing of the Model 8731 Catheter was conducted with cathetersmanufactured with a Pt/Ir tip marker bonding process that was different than the process eventually usedin production. (See FDA483 observation #2.)3. Failure to validate a process whose results cannot be fully verified by subsequent inspection and test asrequired by 21 CFR 820.75(a). For the 8731 Catheter, the Pt/Ir tip bonding process has not been validated(See FDA483 observation #3.)4. Failure to control production processes to ensure that a device conforms to its specifications, asrequired by 21 CFR 820.70(a). For the 8731 Catheter, the tip bonding manufacturing procedures contained

an [redacted] of the tip, and

instructions to [redacted] equipment that was no longer in service. (See FDA483 observation #4.)

5. Failure to implement corrective and preventive action procedures addressing the investigation of thecause of nonconforrnities relating to product, processes, and the quality system as required by 21 CFR820.100(a)(2). Examples include:a. Corrective / Preventive Action System (C/PAS) 747 (re: 8731 tip detachments) was closed with a rootcause analysis that conflicts with information received in complaints. No additional C/PAS was opened toaddress the complaints and failures that do not fit the root cause analysis in C/PAS 747. (See FDA483observation #5a.)b. Product Comment Report (PCR) 170998 reported an 8731 catheter tip detachment and stated that " . ..postoperative the patient showed pain in the left leg, which can be related with the remaining tip ." Inconflict with this reported event, a Health Hazard Analysis and "TECH NOTE" concluded that none of the tipdetachments were associated with adverse clinical or neurological consequences. (See FDA483observation #5b.)c. System Correction Request (SCR) 877, which addresses pump motor stalls due [redacted] to failuresin Synchromed EL implantable infusion pumps, was closed without evidence to support conclusions thatwere made. (See FDA483 observation #5c.)6. Failure toimplement changes in methods and procedures needed to correct and prevent identifiedquality problems, as required by 21 CFR 820.100(a)(5). C/PAS 747 called for a redesign of the catheter tipand a new product specification defining a requirement for [redacted]. However, the productspecification was not changed, and as a result, the revised manufacturing process was not validated, andno process monitoring was conducted. As of the inspection, [redacted] complaints had been receivedinvolving tip dislodgements in catheters produced after the redesign of the tip. (See FDA483 observation#6.)7. Failure to identify all of the actions needed to correct and prevent the recurrence of nonconformingproduct and other quality problems, as required by 21 CFR 820.100(a)(3). In particular:a. C/PAS 747, which covered detachment of Pt/Ir tips in Model 8731 Catheters, did not include an action toaddress 8731 Catheters that were in finished goods or already distributed. (See FDA483 observation#7a.) (NOTE: These Model 8731 Intrathecal Catheters were eventually recalled by your firm on July 21,2006.)b. A field corrective action was not conducted until June 6, 2006, to address recurring Catheter Access Por(CAP) detachment failures in Synchromed EL implantable infusion pumps. (See FDA483 observation #7b.8 . Failure to implement procedures to ensure that device history records for each batch, lot, or unit aremaintained to demonstrate that the device is manufactured in accordance with the device master recordand the Quality Systems regulation as required by 21 CFR 820.184. Specifically:a. Traceability Cards for some Synchromed EL implantable infusion pumps did not include completerecords of operations that were conducted under Manufacturing Process Variances or Product ReviewRequests (PRR's). (See FDA483 observation #8a.)b. A copy of process variance 1955, which covered [redacted] of Synchromed EL pumps, was notmaintained in the documentation control system. (See FDA483 observation #8b.)This letter is not intended to be an allinclusive list of deficiencies at your facility . It is your responsibility


to ensure compliance with the Act and regulations. The specific violations noted in this letter and in theForm FDA483 issued at the close of the inspection may be symptomatic of serious underlying problems inyour firm's manufacturing and quality assurance systems. You are responsible for investigating anddetermining the causes of the violations identified by the FDA. You also must promptly initiate permanentcorrective and preventive action to bring your products into compliance.Federal agencies are advised of the issuance of all Warning Letters about devices so that they may takethis information into account when considering the award of contracts. Additionally, no premarket approvaapplications for Class III devices to which the Quality System regulation deficiencies are reasonablyrelated will be approved until the violations have been corrected. Also, no requests for Certificates toForeign Governments will be granted until the violations related to the subject devices have beencorrected.You should take prompt action to correct the deviations described in this letter. Failure to promptly correcthese deviations may result in regulatory action being initiated by the Food and Drug Administrationwithout further notice. These actions include, but are not limited to, seizure, injunction, and/or civil monepenalties.On July 24, 2006, we received an undated letter from George Aram, Vice President of Quality,Neurological Sector, which describes corrective actions taken and planned by your firm to address theFDA483 Inspectional Observations. Only two of the corrective actions (for FDA483 observations # 8 and9) have been completed. Mr. Aram provided target completion dates for corrective actions to address theremaining FDA483 Inspectional Observations, and he stated that monthly progress reports would beprovided to our office beginning on August 28, 2006 . At this time, based on the limited information thathas been provided, we are unable to determine whether your corrective actions are appropriate. In orderto fully assess the implementation and effectiveness of the corrections, we will need to conduct a followup inspection.[Redacted]Please notify this office in writing within 15 working days to acknowledge receipt of this letter and toprovide an update on the status of your corrective actions. Your response should be sent to Timothy G.Philips, Compliance Officer, at the address on this letterhead.Sincerely,/S/W. Charles BecoatDirectorMinneapolis District

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EXHIBIT 3



Search Archive

Medtronic, Inc. 03Jul07

Department of Health and Human ServicesPublic Health Service Food and DrugAdministration

Minneapolis District Office Central Region 212 Third Avenue South Minneapolis, MN 55401Telephone: (612) 7587133 FAX: (612) 3344142

July 3, 2007WARNING LETTER

CERTIFIED MAIL RETURN RECEIPT REQUESTED

Refer to MIN 07 1Arthur D. Collins, Jr. Chairman of the Board and Chief Executive OfficerMedtronic, Inc.710 Medtronic ParkwayMinneapolis, Minnesota 55432Dear Mr. Collins:During a limited inspection of your establishment, Medtronic Neuromodulation1, located at 800 53rdAvenue Northeast, Minneapolis, Minnesota, 55421, on November 21, 2006, through January 24, 2007,investigators from the Food and Drug Administration (FDA) determined that your establishmentmanufactures implantable drug infusion and neurostimulation products. Under section 201(h) of theFederal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices becausethey are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation,treatment, or prevention of disease, or are intended to affect the structure or any function of the body.Our inspection revealed that your devices are adulterated within the meaning of section 501(h) of the Act[21 U.S.C. § 351(h)], in that the methods used in, or the facilities or controls used for, their manufacture,packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice(CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of FederalRegulations, (21 CFR) Part 820. We received responses from Mr. George Aram, Vice President of Qualityand Compliance, dated February 23, 2007, March 30, 2007, April 30, 2007, and June 4, 2007, concerningour investigators' observations noted on the Form FDA 483, List of Inspectional Observations, that wasissued to officials at your establishment. We address these responses below, in relation to each of thenoted violations. These violations include, but are not limited to:Failure to implement complaint handling procedures to ensure that all complaints are









evaluated to determine whether the complaint represents an event that must be filed as aMedical Device Report under 21 CFR Part 803, as required by 21 CFR 820.198(a)(3).It is our understanding that your establishment documents product complaints in your Product CommentReporting (PCR) system. During the inspection, our investigators found on site several medical and/orscientific literature articles concerning adverse events relating to your devices that had not been enteredinto your PCR system and evaluated for reportability under 21 CFR Part 803 (Medical Device Reporting).See Observation #4 in the Form FDA 483 issued on January 24, 2007. A manufacturer has an obligation tosubmit an MDR report under Part 803 once it becomes aware of information, from any source, thatreasonably suggests that a device it markets may have caused or contributed to an MDR reportable event(21 CFR 803.50). Therefore, your firm should have considered whether the events described in thesemedical and/or scientific articles would represent reportable events under 21 CFR Part 803.In response to this observation, your firm drafted a new literature review SOP that includes proactivesearch methods for selecting relevant articles and reviewing them to determine their reportability. As parof your response, you also provided a new work instruction entitled "Medical Device Reporting" tofacilitate the implementation of the new literature review SOP. This portion of your response appears tobe adequate and will be further evaluated at a future inspection of your facility.Your responses also state that Medtronic Neurological met with CDRH, Office of Surveillance andBiometrics (OSB), on February 2, 2007, to discuss retrospective reporting of MDR reports based onscientific literature. Your firm states that you [redacted]Our inspection revealed that your devices are misbranded under section 502(t)(2) of the Act [21 U.S.C. §352(t)(2)], in that your firm failed or refused to furnish material or information respecting the device thatis required by or under section 519 of the Act (21 U.S.C. § 360i), and 21 CFR Part 803Medical DeviceReporting (MDR) regulation. Significant deviations include, but are not limited to:Failure to submit MDR reports within 30 days of receiving or otherwise becoming aware ofinformation that reasonably suggests that a marketed device may have caused or contributedto a death or serious injury, as required by 21 CFR 803.50(a)(1).Medtronic failed to submit MDR reports for serious injury adverse events that were reported by orconfirmed by a health care professional, or that were reported by a patient or a patient's family member.Examples of this violation include, but are not limited to, the following PCRs:58709, 235359, 258561, 234149, 183288, 202853, 267989, 55251, 94553, 119033, 180984, 246172,255091, 277026, 191620, 95901, 171432, 196649, 248557, 189519, 167978, 61760, 95681, 170773,186498, 187587, 190010, 196714, 202096, 206578, 222730, 250677, 267713, 248978, 221032, 250099, an269319.Many of these PCRs involve a granuloma or inflammatory mass at or near the distal tip of the intrathecalcatheter used with the SynchroMed pump, which are reportable as serious injuries. Some of these weresurgically removed and some of the patients reported increased pain, tingling sensation in the legs, partiaparalysis, total lower limb paralysis and other gait problems resulting from the granuloma orinflammatory mass. Some of the PCRs included a fracture of the intrathecal catheter. It is important tonote that the MDR regulation also provides for the submission of a malfunction MDR for events in whichthe information reasonably suggests that a device you market has malfunctioned and would be likely tocause or contribute to a reportable death or serious injury if the malfunction were to recur. Your firmshould have considered whether the failures reported in the PCRs referenced above would have constitutereportable events under 21 CFR Part 803.Your firm also failed to submit MDR reports within 30 days of becoming aware of literature articles thatreferenced problems to which your devices may have caused or contributed. These include, but are notlimited to, articles by Deer, McMillan et al., Hu et al., Kofler et al., and Loughrey et al. These articlesincluded, among other things, information on pump malfunctions, catheter separation or fracture, andinflammatory ma e and granuloma .In addition, during the inspection of your facility, our investigators collected abstracts of several literaturearticles. The articles associated with these abstracts must be reported as MDRs if they discuss deaths,serious injuries, or malfunctions of your devices that would be likely to cause or contribute to a death orserious injury, if the malfunction were to recur.Your firm's responses indicate that you interpreted the MDR regulation to mean that any consumer selfreported events were not MDR reportable unless separately confirmed by a Health Care Professional(HCP). This interpretation of the MDR regulation is incorrect. Consumer selfreported events do not have


to be confirmed by a HCP in order to determine reportability. Under 21 CFR 803.50, a firm has 30calendar days after the day it receives or otherwise becomes aware of information, from any source, thatreasonably suggests that a device it markets may have caused or contributed to an MDR reportable eventIf, in the process of conducting an investigation, your firm contacts an HCP for additional information, thethe additional information can be used by the firm to help make a determination about the MDRreportability of the consumer complaint.Your responses also state that the MDR Work Instruction was revised to include a requirement to assessconsumer selfreported events (whether or not confirmed by a HCP) and catheter events for MDRreportability. A copy of this revised procedure was provided as part of your responses. Your revised workinstruction appears to adequately address our concern regarding the reporting of consumer selfreportedevents. However, this corrective action will be further assessed at a future inspection of your facility.Our inspection further revealed that your devices are misbranded under section 502(t)(2) of the Act [21U.S.C. § 352(t)(2)], in that your firm failed or refused to furnish material or information respecting thedevice that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806 Reportof Corrections and Removals regulation. Significant deviations include, but are not limited to:A correction or removal conducted to reduce a risk to health posed by a device was notreported in writing to FDA, as required by 21 CFR 806.10(a)(1).In July 2003 your establishment sent a letter with an enclosed "EDUCATIONAL BRIEF," entitled"Information about Inflammatory Mass," to SynchroMed customers (physicians). Also enclosed werereprints of two articles published in the December 2002 issue of Pain Medicine and revised labeling for theSynchroMed Technical Manual. FDA defines a "correction" in 21 CFR 806.2(d) as " . . .the repair,modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a devicewithout its physical removal from its point of use to some other location." FDA believes that the July 2003Educational Brief, which was sent to all customers using SynchroMed pumps, meets the definition of"correction" in that the letter provided updated labeling to customers for devices that were already indistribution.

The FDA also believes that the July 2003 Educational Brief is a reportable correction under 21 CFR806.10(a) (1) in that the letter contained specific information intended to reduce the risk to health posedby the device. For example, the July 2003 Educational Brief specifically states that "[i]f an inflammatorymass is detected in its clinical course, prompt discontinuation of opioid delivery into the mass may causeit to shrink or disappear without the need for surgical removal." The letter also specifically recommendscatheter replacement, repositioning, and other interventional procedures, depending on the patient'sclinical condition. These recommendations were neither included in the pump's original labeling, norconveyed to customers in a January 2001 communication regarding inflammatory masses.Additionally, the July 2003 Educational Brief contained new "Post implant" warnings that suggest thatclinicians should routinely monitor patients for prodromal clinical signs or symptoms of inflammatorymass such as change in character, quality or intensity of pain; reports of new radicular pain, especially ator near the dermatomal level of the catheter tip; frequent or large escalations of daily drug dose tomaintain the analgesic effect; and dose escalations that may only temporarily alleviate the patient'sincreasing pain. These new warnings were not included in the January 2001 letter or the pump's originaltechnical manual.Furthermore, the journal articles included with the July 2003 Educational Brief stated with regard toadverse event reporting that 41 adverse events regarding inflammatory mass were identified as ofNovember 2000 (conveyed to customers in the January 2001 letter). The articles also state that anadditional 51 events were identified after the 2001 letter had been distributed to customers. The articlessuggest that the number of new adverse events has more than doubled in one year of reporting. It isnoteworthy that during the most recent inspection of your facility, your firm calculated the current rate ofinflammatory masses to be approximately [redacted] events per [redacted] implants. This figure,which has not yet been communicated to your customers, suggests that the risk of inflammatory massesoccurring at or near the tip of intrathecal catheters used with SynchroMed pumps is [redacted] greaterthan the [redacted] rate indicated in the January 2001 letter.Your firm's responses to this observation stated that the July 2003 Inflammatory Mass "Educational Brief"was based upon your judgment that the information presented in the Brief was an update to a January 19,2001, "Dear Colleague" letter that had been reviewed by FDA prior to its issuance. You further stated thatthe Agency did not consider the 2001 "Dear Colleague" letter to be a correction or removal at that time. Iaddition, you stated that the revised labeling contained in the July 2003 Educational Brief had been


previously reviewed by FDA as part of PMA Supplement P860004/S053, which was approved by FDA onOctober 9, 2002. Your firm indicated that the July 2003 Educational Brief did not constitute additionalinformation beyond the approved labeling in the PMA Supplement.FDA disagrees with your conclusion that the July 2003 Educational Brief was not a correction or removal.Although the Educational Brief contained language consistent with the approved labeling in PMASupplement P860004/S053, this new labeling had not been previously communicated to physicians whosepatients already had a SynchroMed pump implanted within them. Note that the 21 CFR Part 806 definitionsand requirements do not depend upon whether the revised labeling in the July 2003 Education Brief hadgone through the PMA supplement process or that FDA had prior knowledge of the information through aPMA supplement. Your firm is required to review each corrective action and/or removal and determinewhether the requirements of the regulation have been met and thus require a report. Providing theinformation to FDA via another requirement does not abrogate your responsibility to comply with therequirements of 21 CFR Part 806. If your firm determines that the event in question is not reportable, youmust provide an explanation of your decision not to submit a Corrections and Removals report and keep arecord of this justification, as required by 21 CFR 806.20.Our inspection also revealed that your firm has several procedures for Medical Device Reporting andAdverse Drug Experience Reporting. These procedures, in turn, reference several other procedures. Yourfirm's current problems regarding MDR reporting, as discussed above in this Warning Letter, may beexacerbated by the complexity of your procedures and might have contributed to your firm's deviationsfrom the regulations regarding MDR reporting.

In addition, the inspection revealed several ongoing violations in your quality system that were also notedin the 483. In particular, you have failed to achieve consistent compliance in areas such as design control(21 CFR 820.30) and corrective and preventive action (21 CFR 820.100). These areas had previously beenfound not to be in compliance during the inspection performed from May 18 through June 22, 2006. Thesequality system violations were also cited in an August 29, 2006, Warning Letter that was sent to you. Byletter dated June 4, 2007, George Aram, Vice President of Quality, Neurological Sector, provided anupdate on the status of the corrective actions taken and planned by your firm to address these violations.In that letter, Mr. Aram stated that the longest remediation activities extend into November 2007. Weencourage you to expedite your efforts to achieve full compliance and to keep us informed of yourprogress.In your firm's June 4, 2007 response, you also indicated that your Risk Evaluation Board (REB) met onMay 10, 2007, to [redacted]This letter is not intended to be an allinclusive list of deficiencies at your facility. It is your responsibilityto ensure compliance with the Act and regulations. The specific violations noted in this letter and in theForm FDA 483 issued at the close of the inspection may be symptomatic of serious underlying problems inyour firm's manufacturing and quality assurance systems. You are responsible for investigating anddetermining the causes of the violations identified by he FDA. You also must promptly initiate permanentcorrective and preventive action to bring your products into compliance.Federal agencies are advised of the issuance of all Warning Letters about devices so that they may takethis information into account when considering the award of contracts. Additionally, no premarket approvaapplications for Class III devices to which the Quality System regulation deficiencies are reasonablyrelated will be approved until the violations have been corrected. Also, no requests for Certificates toForeign Governments will be granted until the violations related to the subject devices have beencorrected.You should take prompt action to correct the deviations described in this letter. Failure to promptly correcthese deviations may result in regulatory action being initiated by the Food and Drug Administrationwithout further notice. These actions include, but are not limited to, seizure, injunction, and/or civil monepenalties.Please notify this office in writing within 15 working days to acknowledge receipt of this letter and toprovide an update on the status of your corrective actions. Your response should be sent to Timothy G.Philips, Compliance Officer, at the address on this letterhead.Sincerely,/S/W. Charles Becoat Director


Minneapolis District TGP/ccl______________________________________________________________________1At the time of the FDA's inspection, the establishment was known as Medtronic Neurological.





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EXHIBIT 4



Search Archive

Medtronic Puerto Rico Operations Company

Department of Health and Human ServicesPublic Health ServiceFood and Drug Administration

San Juan DistrictCompliance Branch466 Fernandez Juncos AvenueSan Juan Puerto Rico 009013223Telephone: 7874749500FAX: 7877296658

June 1, 2009

WARNING LETTERSJN200908

Certified MailReturn Receipt Requested

Mr. William A. HawkinsCEO and PresidentMedtronic Inc.710 Medtronic ParkwayMinneapolis, MN 554325604

Dear Mr. Hawkins:

Food and Drug Administration

During an inspection of your firm located at Road 31 Km 24 Ceiba Norte Industrial Park Juncos, PuertoRico, on November 12, 2008, through December 15, 2008, investigators from the United States Food andDrug Administration (FDA) determined that your firm manufactures Synchromed® II Pumps and MiniMedParadigm® Insulin Pumps. Under section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act), 21U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of diseaseor other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended toaffect the structure or function of the body.

This inspection revealed that the Synchromed® II Pumps are adulterated within the meaning of section501 (h) of the Act (21 U.S.C. §351 (h)), in that the methods used in, or the facilities or controls used for,









their manufacture, packing, storage, or installation are not in conformity with the Current GoodManufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Codeof Federal Regulations (C.F.R.), Part 820. We received written responses from Mr. Manuel Santiago, VicePresident of Medtronic Puerto Rico Operations Company (MPROC), dated January 20, 2009, and March31,2009, concerning our investigators' observations noted on the form FDA 483, List of InspectionalObservations that was issued to your firm. We address these responses below, in relation to each of thenoted violations. These violations include, but are not limited to, the following:

1) Failure to establish and maintain process control procedures that describe any process controlsnecessary to ensure conformance to specifications, which shall include monitoring and control of processparameters and component and device characteristics during production, as required by 21 CFR 820.70(a)

For example:

a) Multiple Synchromed® II Pumps were released for distribution and implanted in patients even thoughthey were not filled with propellant as required by your Process Operation Description (POD) (b) (4) Yourfirm's investigation, Nonconformance Report (NCR) (b) (4) which started in (b) (4) found that severalimplantable pumps, including serial numbers NGV300069H, NGV301133H, NGP302823H, NGV300225H,NGV401554H, NGV4022253H, NGP307091H, NGP301055H, and NGP304851H, were released to the marketwithout being filled with propellant and this was not discovered in the propellant weight check duringmanufacturing. Your firm's manufacturing step requires a (b) (4) after the propellant is added to thepump. The 100% mass check was ineffective to identify that devices lacked the propellant. You becameaware of this situation after confirming two complaints receive on (b) (4) (Product Comment Report(PCR) (b) (4) and (b) (4) (PCR (b) (4) PCR (b) (4) states that the product had to be explanted becauseof issues related to the lack of propellant. PCR (b) (4) created in (b) (4) also documented that twopumps had to be explanted on (b) (4) and (b) (4) due to lack of propellant.

b) On June 23, 2008, at the (b) (4) one Synchromed® II Pump was found that did not show evidence of perforated septum. The (b) (4) is performed at this station. The (b) (4) is performed to detectobstruction in the (b) (4) early in the manufacturing process. (b) (4)As part of your firm's assessment(Nonconformance Evaluation Request (NCER) (b) (4) that were at this manufacturing stage were visuallyinspected. This inspection revealed that (b) (4) of the (b) (4) Synchromed® II Pumps did not contain the(b) (4) indicating that the (b) (4) was not conducted on these (b) (4) Synchromed® II Pumps.

c) On June 25, 2008, at the (b) (4) one Synchromed® II Pump was found without a (b) (4) at the (b)(4) The (b) (4) needs to be perforated to test the (b) (4) The (b) (4) is a safety mechanism that servesto assure that the pump is never overfilled. As part of your firm's assessment (NCER (b) (4) ,theSynchromed® II Pumps in the firm's existing inventory at MPROC were visually inspected. (b) (4) werefound without the (b) (4) However, the electronic device history record for these devices showed entriesindicating that the (b) (4) was conducted. Your firm expanded the scope of the investigation (NCR (b) (4and found (b) (4) additional Synchromed® II Pumps where the (b) (4) pressure was not conducted and(b) (4) devices with testing discrepancies. Your firm's investigation further determined that a total of (b)(4) Synchromed® II Pumps had records that indicated that the (b) (4) was performed, when the test wanot actually conducted. Of these affected devices, (b) (4) pumps were distributed to customers.

We have reviewed your responses dated January 20, 2009, and March 31, 2009, and our conclusionsfollow:

a) Regarding the corrective actions that your firm has taken to address the Synchromed® II Pumps withthe missing propellant, you initially identified this problem in May 2006. You initiated a corrective andpreventive action (CAPA) investigation in January 2007, determined the root cause to be related to the (b(4) failing to properly fill propellant into the Synchromed® II Pump reservoir, and failure of (b) (4) toverify the fill weight of devices after being processed through the filling equipment. Your firm conducted aHealth Hazard Assessment in March 2008. In May 2008, your firm conducted a voluntary recall of theSynchromed® II Pumps that did not contain any propellant, and notified the FDA. Your firm's responseindicates that MPROC has confirmed that the corrective actions regarding the Synchromed® II Pumps withthe missing propellant were completed and effective. FDA is concerned with your failure to initiate a recal


for devices affected by the propellant problem in a timely manner. Based on the chronology identified inyour response, it took almost 2 years from when the missing propellant was initially identified to conducta recall. The adequacy of your response cannot be determined at this time. FDA will assess theeffectiveness of your firm's recall procedures and CAPA's during the next inspection.

b) Regarding the actions that your firm has taken to prevent recurrence of Synchromed® II Pumps frombeing distributed without propellant, you conducted process validation for the manufacturing processchanges between April and May 2007. Subsequently, you updated your procedures and retrained yourpersonnel on these procedures. The adequacy of your response cannot be determined at this time. FDAwill assess the effectiveness of your CAPA's during the next inspection.

c) Regarding the failure to conduct the and the (b) (4) and (b) (4) the adequacy of the response cannotbe determined at this time. Based on your response, the root cause was determined to be related to (b)(4) manufacturing instructions for the Synchromed® II Pumps. MPROC has performed detailed HealthHazard Analyses for these two problems. Your firm has established additional checkpoints in themanufacturing process to verify the (b) (4) and (b) (4) are being completed; reviewed themanufacturing process to ensure that the steps were correct and specific; retrained employees inperforming the manufacturing steps; and established additional oversight by increasing the internalprocess audits of the Synchromed® II Pump manufacturing operation. Your firm identified otherimprovement actions that will be implemented within the next year, as identified by the timetable in yourresponses. The adequacy of your corrective and preventive actions will be determined during the nextinspection.

2) Failure to establish and maintain procedures for implementing corrective and preventive action thatinclude identifying the action(s) needed to correct and prevent recurrence of nonconforming product andother quality problems, as required by 21 CFR 820.100(a).

For example:

On October 5, 2008, your firm performed a (b) (4) of data from the (b) (4) records (which stores theresults of inprocess testing) and the (b) (4) manufacturing records (which controls the manufacturingprocess for the Synchromed® II Pump). The intent of the (b) (4) was to provide another level ofoversight to ensure that inprocess tests were actually being performed on devices, as they progressedthrough manufacturing. This report, however, revealed that another step, (b) (4) for each Synchromed®II Pump, was not performed during manufacturing. (b) (4) are unique to each device and have valuesthat vary from (b) (4) This constant is used by the device in critical internal functions such as calculatingdrug reservoir levels and drug dispensing rates. Our investigators found over (b) (4) complaints in yourfirm's complaint handling system related to accuracy rates. The (b) (4), report did not reference any NCRor other type of investigation into this problem.

We have reviewed your responses dated January 20, 2009, and March 31, 2009, and our conclusionsfollow:

Your responses state that a comprehensive review of the CAPA procedures at MPROC will be conducted byJuly 31, 2009. The adequacy of your response cannot be determined at this time. The adequacy of yourfirm's corrective actions will be determined during the next inspection.

3) Failure to establish and maintain procedures to ensure that Device History Records (DHR's) for eachbatch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with theDevice Master Record (DMR), as required by 21 CFR 820.184.

Specifically, a review of thirteen (13) DHR's for the Synchromed® II Pumps revealed that your firm'sprocedure entitled (b) (4) (Procedure POD (b) (4) Revision (b) (4) is not always followed. For example

a) A comparison between DHR's for the Synchromed® II Pump serial numbers NGP319205H and


NGV416698H, and the respective (b) (4) revealed that these two devices were dispatched into thesterilizer after the (b) (4) Your procedures require that the devices be placed into the (b) (4)

b) DHR's for Synchromed® II Pump serial numbers NGV416743H, NGV404480H, NGV417063H,NGP306174H, NGV416451H, NGV416578H, NGV418943H, and NGP305847H show that the verification ofthe (b) (4) and (b) (4) and (b) (4) were recorded after the steam sterilization cycle had completed, andnot prior to initiating the cycle, as required by Procedure POD (b) (4)

We have reviewed your responses dated January 20,2009, and March 31, 2009, and our conclusionsfollow:

Your responses states that the devices described above went through the complete sterilization process,and were determined to be sterile at the conclusion of the cycle. However, your firm acknowledges thatthe sterilization process was not performed in the order specified by your procedures. The adequacy ofyour response cannot be determined at this time. The adequacy of your firm's corrective and preventiveactions will be determined during the next inspection.

4) Failure to review, evaluate, and investigate complaints involving the possible failure of a device,labeling, or packaging to meet any of its specifications, as required by 21 CFR 820.198(c).

For example: (b) (4) received on (b) (4) and (b) (4) received on (b) (4) both describe events where patients whowere implanted with the Synchromed® II Pump developed infections. A review of the DHR's for thedevices identified in the PCR's Synchromed® II Pump serial numbers NGP319205H and NGV416698H,respectively) show that the devices were dispatched into the sterilizer after the (b) (4) had alreadystarted. The complaint records stated that an investigation had been opened to assess these complaints.However, a copy of this investigation was not included as part of the complaint record, there was noreference to a specific investigation report number, and there was no documentation whether theinvestigation was successfully closed. Also, there was no record in the complaint file that Medical DeviceReports were filed by your firm with FDA for this complaint.

Your responses dated January 20, 2009 and March 31, 2009, did not address this charge because it wasnot included in the FDA 483 issued to you on December 15, 2008. The adequacy of your corrective andpreventive actions will be determined during the next inspection.

Our inspection also revealed that your MiniMed Paradigm® Insulin Pumps are misbranded under section502(t)(2) of the Act [21 U.S.C. 352(t)(2)], in that your firm failed or refused to furnish material orinformation respecting the device that is required by or under section 519 of the Act, 21 U.S.C. 360i, and21 C.F.R. Part 803 Medical Device Reporting (MDR) regulation. Significant deviations include, but are notlimited to, the following:

5) Failure to report to FDA no later than 30 calendar days after the day that you receive or otherwisebecome aware of information, from any source, that reasonably suggests that a device that you market:(1) may have caused or contributed to a death or serious injury; or (2) has malfunctioned and this deviceor a similar device that you market would be likely to cause or contribute to a death or serious injury, ifthe malfunction were to recur, as required by 21 CFR 803.50(a).

For example:

a) Complaint No. (b) (4) states that the reported complaint was not reportable as an MDR to the FDAbased on testing of the returned MiniMed Paradigm® Insulin Pump. Information in the complaint indicatedthat the patient was hospitalized for diabetic ketoacidosis allegedly following battery problems with thepump. The complaint file states that analysis of the pump did not find a battery problem. Your firmconcluded that although "information does suggest that a device malfunction occurred," the malfunction


was unlikely to result in death or injury if it were to recur.

However, a review of the MDRs submitted by your firm to the FDA through MedWatch shows that yourfirm has submitted serious injury MDRs with a diagnosis of diabetic ketoacidosis resulting from the use ofthe MiniMed Paradigm® Insulin Pump. Since your firm has previously reported these MDRs where apatient had been hospitalized for diabetic ketoacidosis from the use of the MiniMed Paradigm® InsulinPump and your firm received a complaint of a similar nature, this device malfunction, if it were to recur,would be likely to cause or contribute to the same serious injury. Furthermore, under 21 CFR 803.3,"Caused or contributed means that a death or serious injury was or may have been attributed to a medicadevice, or that a medical device was or may have been a factor in a death or serious injury...."

Based on the information in the complaint file, device failure or malfunction may have contributed to orcaused the user's hospitalization and the device's malfunction would be likely to cause or contribute to adeath or serious injury, if the malfunction were to recur. As a result, this serious injury is a reportableMDR event under 21 CFR 803.50(a). Your firm did submit MDR (b) (4) for this complaint. The "Date ofEvent" and the "Date of Report" are listed as May 30, 2007. Your firm reported this as a serious injury onthe Mandatory Reporting Form, FDA3500A, on November 14, 2008, which is 18 months after the day thatyour firm received information of an MDR reportable event.

b) Complaint (b) (4) states that the reported complaint was not reportable as an MDR to the FDA basedon testing of the returned MiniMed Paradigm® Insulin Pump. The information in the complaint indicatedthat the user contacted your firm because the user had a blood glucose level of 456, and that the user'sMiniMed Paradigm® Insulin Pump had failed to alarm when it stopped delivering insulin. The user wassubsequently hospitalized and diagnosed with diabetic ketoacidosis. Followup revealed that the user hadtrouble keeping the user's blood glucose level down, and when the user replaced infusion sets, thecannulas were bent. The complaint record states that, (b) (4) Under 21CFR 803.3, "Caused or contributed means that a death or serious injury was or may have been attributedto a medical device, or that a medical device was or may have been a factor in a death or seriousinjury...." In this instance, the patient had complained of a potential device failure, and the patient wassubsequently hospitalized for diabetic ketoacidosis. Based on the information in the complaint file, becausyour firm was aware of information that reasonably suggested that the user's MiniMed Paradigm® InsulinPump may have caused or contributed to a serious injury, you were required to report this event to FDAas an MDR within 30 calendar days of receiving or otherwisebecoming aware of this information, under 21 CFR 803.50(a).

We have reviewed your responses dated January 20,2009, and March 31, 2009, and our conclusionsfollow:

Your responses state that MDR reports were submitted for the complaints identified above. Your firm hasalso updated your procedure (b) (4) Medical Device Report (Effective Date: December 17, 2008), to reflect new criteria for MDRreporting, and retrained your employees on the new procedure on December 16, 2008. The adequacy ofyour corrective and preventive actions will be determined during the next inspection.

6) Failure to have a person who is qualified to make a medical judgment reasonably conclude that adevice did not cause or contribute to a death or serious injury, or that a malfunction would not be likely tocause or contribute to a death or serious injury if it were to recur, as required by 21 CFR 803.20(c)(2).Persons qualified to make a medical judgment include physicians, nurses, risk managers, and biomedicalengineers, under 21 CFR 803.20(c)(2).

For example:

Our investigators determined that a product reporting specialist was making decisions about MDRreportability for the MiniMed Paradigm® Insulin Pumps. The training record for this particular employeeshowed that this person only had a high school diploma with some additional inhouse training.


Your responses dated January 20,2009 and March 31, 2009, did not address this charge because it was noincluded in the FDA 483 issued to you on December 15, 2008. The adequacy of your corrective andpreventive actions will be determined during the next inspection.

You should take prompt action to correct the violations addressed in this letter. Failure to promptly correcthese violations may result in regulatory action being initiated by the Food and Drug Administrationwithout further notice. These actions include, but are not limited to, seizure, injunction, and/or civil monepenalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so thatthey may take this information into account when considering the award of contracts. Additionally,premarket approval applications for Class III devices to which the Quality System regulation deviationsare reasonably related will not be approved until the violations have been corrected. Requests forCertificates to Foreign Governments will not be granted until the violations related to the subject deviceshave been corrected.

Please notify this office in writing within fifteen (15) working days from the date you receive this letter ofthe specific steps you have taken to correct the noted violations, including an explanation of how you planto prevent these violations, or similar violations, from occurring again. Include documentation of thecorrective action you have taken. If your planned corrections will occur over time, please include atimetable for implementation of those corrections. If corrective action cannot be completed within 15working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be sent to:

U.S. Food and Drug AdministrationAttn: Mrs. Maridalia TorresDistrict Director466 Fernandez Juncos AvenueSan Juan, PR 009013223

If you have any questions about the content of this letter please contact Ms. Margarita Santiago,Compliance Officer, at (787) 4744789.

Finally, you should know that this letter is not intended to be an allinclusive list of the violations at yourfacility. It is your responsibility to ensure compliance with applicable laws and regulations administered bFDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm'smanufacturing and quality assurance systems. You should investigate and determine the causes of theviolations, and take prompt actions to correct the violations and to bring your products into compliance.

Regarding your firm's CAPA's for the Synchromed® II Pumps that did not have the (b) (4) test performeon them, your firm has not indicated how it will address product that is currently distributed to customersFDA's review of your firm's investigation report(NCR (b) (4) did not reveal any evidence to demonstratethat (b) (4) was tested in subsequent manufacturing steps to verify that the safety mechanism performeas intended. As stated in the charges above, (b) (4) Synchromed® II Pumps on which the (b) (4) wasnot performed were distributed to customers. Should your firm undertake a voluntary correction orremoval for the Synchromed® II Pumps where (b) (4) the was not performed, it must submit a writtenreport to FDA within 10 working days of initiating such an action, as specified by 21 CFR 806.10(a) & (b).See 21 CFR part 806 for additional information about correctives and removals.

In addition to the above charges, our inspection revealed that your firm uses one manufacturing processsystem for both the Synchromed® II Pumps and the MiniMed Paradigm® Insulin Pumps. To the extentthat any of the above CGMP violations for the Synchromed® II Pumps also implicate the MiniMedParadigm® Insulin Pumps, your corrective actions should address and extend to the manufacturingprocedures of the MiniMed Paradigm® Insulin Pumps.


Sincerely,/S/Maridalia Torres IrizarryDistrict DirectorSan Juan District

Enclosure: Form FDA 483

cc: Mr. Manuel SantiagoVice PresidentMedtronic Puerto Rico Operations CompanyCall Box 4070Juncos, PR 00777

cc: HFC210 (electronic via CMS)HFZ333 Nikhil Thakur, CDRHHFI35 (redacted via CMS)HFRSE1DD (MTI)DIB (VM)CSO (Marilyn Santiago)EF (3004369318)CBRFCB WL File

MS/meb: 06012009

H:\Compliance Branch\Compliance Officers\Santiago\medtronic\Medtronic WL 200908 dated 06012009.doc





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EXHIBIT 5


Medtronic, Inc. 7/17/12

Department of Health and Human ServicesPublic Health ServiceFood and Drug Administration

Minneapolis District OfficeCentral Region250 Marquette Avenue, Suite 600Minneapolis, MN 55401Telephone: (612) 3344100FAX: (612) 3344142

July 17,2012WARNING LETTER

Refer to MIN 12 39

CERTIFIED MAILRETURN RECEIPT REQUESTEDOmar S. IshrakChief Executive OfficerMedtronic, Inc.710 Medtronic ParkwayMinneapolis, Minnesota 55432Dear Mr. Ishrak:During an inspection of your firm, Medtronic Neuromodulation, located at 7000 Central Avenue NE, inMinneapolis, Minnesota, from March 14 through May 9, 2012, investigators from the United States Foodand Drug Administration (FDA) determined that your firm manufactures implantable drug infusionsystems, deep brain stimulation systems, spinal cord neurostimulation systems, nerve monitoringproducts, and other neurological medical/surgical products. Under section 201(h) of the Federal Food,Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they areintended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, orprevention of disease, or are intended to affect the structure or function of the body.This inspection revealed that these devices are adulterated within the meaning of section 501(h) of theAct, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, theirmanufacture, packing, storage, or installation are not in conformity with the Current Good ManufacturingPractice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of FederalRegulations (21 CFR), Part 820. We received a response from Thomas M. Tefft, Senior Vice President andPresident, and Jill Smith, Vice President, Quality, dated May 30,2012 (and updated on June 29, 2012)concerning our investigators' observations noted on the Form FDA 483, List of lnspectional Observations,issued to Mr. Tefft on May 9, 2012. We address the response below, in relation to each of the notedviolations. These violations include, but are not limited to, the following:1. Failure to establish adequate procedures for corrective and preventive action as required by 21 CFR820.100(a). Specifically:

A) You have not identified the actions to correct and prevent recurrence of nonconforming product.









GCAPA 1485, opened October 26, 2007, relates to motor corrosion resulting in device field failure(motor stall). Within the Investigation Report for SynchroMed II Pump Corrosion (NDHF111988863)it states "corrosion[ ... ] can result in partial or complete removal of gear teeth." This can "seize"the motor altogether or "gear wheel [ ... ]will continue to rotate, but there may be no drug deliveryin the region of missing teeth." Identified corrosion issues include wheel 3 corroded teeth, gearbinding, gear shaft binding, and bearing binding. This GCAPA includes 567 complaints and has notbeen closed.

FDA 483 Response: Your response describes actions taken to mitigate the risk of device failure throughcommunication to healthcare professionals and decreased susceptibility of the device to corrosion.However, we have concluded that your response is not adequate. Health Hazard Analysis for SynchroMedII Pump Motor Corrosion (CAPA #1485), NDHF1119101573, Version 4.0, predicts an additional (b)(4) patient injuries resulting from device failure due to motor corrosion. This analysis was based only onconfirmed failures (via returned product analysis) due to corrosion; and thus, the number of additionalpatient injuries will likely be higher than predicted.Your response also discusses the activities of your Corrosion Task Force (CTF) and your planned indepthreview of SynchroMed II complaints alleging a motor stall without a product. CAPA 1485 and the HealthHazard will be updated. (b)(4)FDA requests a prompt meeting with you to discuss the pump motor corrosion failure mode and the scopeand timing of corrective actions to address this ongoing problem. We propose Friday, September 7, 2012,at 10:00 a.m. EST for this meeting to be held at the Center for Devices and Radiological Health, 10903New Hampshire Avenue, Building 66, Silver Spring, Maryland. Please contact John Diehl, RegulatoryOperations Officer,· (301) 7960993, to confirm your participation.

B) The "Corrective and Preventive Action (CAPA) Procedure," (QMS1861) states "assess qualityissues, trends, and potential or actual product or process nonconformities." This was not completedin that data used for evaluation was incomplete per citations 2 and 3 below.

FDA 483 Response: Your response states that you updated Product Event (PE) inclusion criteria for CAPA1485 to include appropriate PEs associated with nonreturned product. The CAPA 1485 Health HazardAnalysis will be updated accordingly, and the field corrective action decision will be reevaluated.You also updated the form for PE inclusion criteria to require a documented rationale when PEs with nonreturned product will not be assigned to the applicable CAPA. Further, you stated that upon completion ofremediation activities to address FDA483 observations 2 and 3, you will reevaluate the impact to allopen productrelated CAPAs, monitors, and trends.We consider your proposed corrective actions to be appropriate; however, a followup inspection will benecessary to evaluate the implementation and effectiveness of the actions.2. Failure to establish adequate procedures for receiving, reviewing, and evaluating complaints by aformally designated unit, which is required by 21 CFR 820.198(a). Specifically, Patient and TechnicalServices (PATS) did not document complaint information for incoming calls per the procedure "CustomerResponse Team Systems [CRTS]" (PTS6026). A complaint is defined as "Any written, electronic or oralcommunication that alleges deficiencies related to the identity, quality, durability, reliability, safety,effectiveness, or performance of a device ... " and the Patient and Technical Consultant "Identifies anddocuments any report of a Complaint." Complaint information received during a call was not documentedin the written call record for the following:

Call Number Information Received in Phone Call NotDocumented on Resultant Written Call Record

2685890

A doctor requested information on whether catheterremoval is an option with a granuloma. This callwas not handled as a complaint for agranuloma/inflammatory mass.

2757084

Health care provider called to report a motor stalland that the patient experienced withdrawalsymptoms. Withdrawal symptoms were notdocumented on the written call record or resultingcomplaint.


2721299

Caller stated that Fentanyl was in pump. The drugwas not documented on the written call record andthe resulting complaint states drug description is“Unknown.”

2739594

Caller reported a motor stall with no recovery. Caller stated Baclofen as the medication in thepump. The drug was not documented on the writtencall record and the resulting complaint states drugdescription is “Unknown.”

2702294

Caller reported a vibration sensation and stated that“pump is not working.” The pump not working wasnot documented on the written call record orresulting complaint.

2724877

Caller reported a vibration sensation and that pumpis “not working for pain, like it has all theseyears.” Pump not working for pain was notdocumented on the written call record or resultingcomplaint.

2694377

Caller reported that pain became worse sincedevice implantation which was not documented onthe written call record or resulting complaint.

2579227

Caller reported Baclofen is in the pump. The drugwas not recorded on the written call record and theresulting complaint states drug description is“Unknown.”

2718965

Caller reported a granuloma and stated within thecall that “the medicine worked in the beginning, butover time, it made me worse. And I didn’t know ituntil it stopped working.” The information about themedication was not captured on the written callrecord or resulting complaint.

FDA 483 Response: Your response states that you reviewed the audio call records and revised thewritten records accordingly. The events were reviewed again to determine whether Medical DeviceReports (MDRs) or Adverse Drug Experience Reports (ADRs) should be filed or supplemented. Reportswere submitted when required. Lastly, assigned codes were reevaluated and revised if necessary.Broader corrective and preventive actions completed or promised include training, management review ofcalls and CRTS records, procedural changes, and audits of Patient and Technical Services procedures andprocesses.Your corrective actions appear to be appropriate; however, a followup inspection will be necessary toevaluate implementation and effectiveness.3. Failure to review, evaluate and investigate, where necessary, complaints involving the possible failureof a device to meet any of its specifications. This is required by 21 CFR 820.198(c). Specifically:

A) Product Performance Specialists did not adequately evaluate complaints.(1) Per the procedure "Product Performance Specialist Work Instruction," (RPMWI1666) nonreturned product with suspected nonconformance is to be formally investigated. Eleven of 11closed complaints involving motor stalls with unknown cause and no returned product were noformally investigated nor was there an adequate explanation for why no investigationoccurred. These complaints include:500073583: Motor stall, pain reported, volume discrepancy500099975: Motor stall, nausea, vomiting


500047736: Motor stall, volume discrepancy, withdrawal, pump explanted500079921: Motor stall, volume discrepancy, pain500050534: Motor stall, underdose, pump explanted500031251: Motor stall, return of symptoms500054080: Motor stall, increased pain, underdose symptoms, pump explanted500024556: Motor stall, pain reported, pump explanted500022409: Motor stall, underdose, pump explanted700099823: Motor stall, no therapeutic effect700062012: Motor stall, withdrawal symptoms

FDA 483 Response: Your response states that the Neuromodulation Complaint Evaluation Team (NCET)initiated an investigation and recommended that PEs alleging motor stall be assessed and dispositioned toopen CAPAs, CAPA monitors, Data Monitors, and/ or PITCH Events. Additional broader corrective actionsinclude development of improved criteria for complaint investigations and revisions to the Risk EvaluationBoard (REB) and Product Performance Trend Reporting procedures.Your corrective actions appear to be appropriate; however, a followup inspection will be necessary toevaluate implementation and effectiveness.

(2) An investigation into reports of vibrating pumps entitled "WATCHLISTPatient Reports of PumpVibrations" was opened on March 30, 2007, and closed February 7, 2008. This investigation included19 separate complaints. It was determined that "the likely cause for these vibrations is aphysiological sensation due to surgery and the healing process."The following complaints involving "vibration" sensations were not investigated nor was there anadequate explanation for why no investigation occurred:

Complaint Number

Implant Date Notified Date Description

700074933 6/1/2006 12/2/2011 Inflammatory mass,vibrating sensation

500083053 3/9/2010 4/29/2011

Vibrating sensation,caller reported pump"hasn't been working"

500078876 4/28/2007 7/11/2011

Vibration, caller reportedpump "not working like itused to"

500047418 8/28/2007 10/6/2011

Abdominal vibration,withdrawal,catheter punctures

500205241 1/7/2010 10/3/2011

Vibration sensation

500167917 3/7/2011 8/10/2011

Painful vibration inabdomen

700074795 11/7/2007 12/1/2011

Vibration felt in stomach

700078229 11/30/2005 12/14/2011

Vibration sensation,patient reports pump notworking

700085549 2/28/2011 1/13/2012

Vibration sensation

1/3/2011 Vibration sensation,increased


500038321 1/17/2007 weakness

500037974 4/12/2004 12/16/2010

Vibration sensation,catheter kink

500073385 12/21/2007 4/23/2010

Vibration sensation

500091223 6/30/2009 1/18/2011

Vibration sensation

500046267 5/26/2010 10/6/2011

Feeling vibration, pain,blisters, and fluid in frontof pump

500184025 3/24/2011 6/29/2011

Vibration sensation inabdomen down to lowergroin

500099975 5/22/2007 3/15/2010

Vibration sensation, 3months later patientexperienced motorstall

FDA 483 Response: Your response states that Neuromodulation initiated a PITCH (PreliminaryInvestigation and Trending for Complaint Handling) event to investigate potential causes and similarities Idifferences related to allegations of vibration with the SynchroMed II pump.Your corrective actions appear to be appropriate; however, a followup inspection will be necessary toevaluate implementation and effectiveness.

(3) The procedure "Complaint Evaluation and Investigation Process" (RPM1234) states "assignappropriate functional area(s) to further investigate the issue." Complaint 500082715 was notassigned to the functional area of Medical Safety. The complaint description states "HCP reports adeath of a patient that had a gastric stimulator implanted. He died on Monday, according to whatwas reported to us he could not swallow, he had severe acid in his body."

FDA 483 Response: Neuromodulation rereviewed the complaint and clearly documented theinvestigation activities. The complaint was reviewed by a Medical Safety physician, and an MDR was filedfor the event. In addition, you promised to implement a more detailed process for medical review ofcomplaints and develop a remediation plan for review of prior complaint flies.Your actions are appropriate; however, a followup inspection will be necessary to evaluateimplementation and effectiveness.

(4) The procedure "Product Performance Specialist Work Instruction" (RPM 1666) states "check forrelationship of issue to existing investigations (e.g. [ ... ] CAPA or Data monitor)."

a. Complaint 500037816 was a returned product due to volume discrepancies at multiplerefills. The analysis stated "corrosion and residue were seen on both sides of gear wheel." Thicomplaint was not added to GCAPA 1485 for motor corrosion.b. Complaint 500091325 stated the following on the Medical Device Report: "furtherinformation received from the healthcare provider indicated she believed the lead hadmigrated." This complaint was not added to the Data monitor for "migration" for urinaryInterStim.

FDA 483 Response: Your firm rereviewed complaints 500037816 and 500091325 and documented theinvestigations and conclusions. For complaint 500091325, coding was corrected and the monitor wasupdated.Your corrective actions appear to be appropriate; however, a followup inspection will be necessary toevaluate implementation and effectiveness.

B) Coding of similar complaints is inconsistent.Procedure "Complaint and Adverse Event Coding and Master Data Management Process"


(RPMWI1833) describes "what codes will be assigned in the PEs" (complaints) that couldsubsequently be used for trend analysis. Each complaint is to receive a (b)(4) code defined as:(b)(4)Of the following 14 complaints relating to similar motor stall issues(700062012,500082653,500024556,500099975,500073583,500047736,500079921,500052853,500054080,500050534,500075490,500031526, 700095413,500031251:

• 4 received a (b)(4)• 10 received (b)(4)• 2 received a (b)(4)• 9 received a (b)(4)• 3 received a (b)(4)Of the following 10 complaints relating to similar inflammatory mass issues(500166572,500054756,500050731,500071678,500093511,500075527, 500093970, 500043194,500074339, 700069121):• 5 received a (b)(4)• 1 received a (b)(4)• 2 received a (b)(4)• 2 received a (b)(4)• 6 received a (b)(4)• 3 received a (b)(4)• 1 received a (b)(4)

FDA 483 Response: Your response states that you implemented a secondary review of coding decisionsto ensure accuracy and consistency (b)(4). Neuromodulation committed to a comprehensive assessmentprocesses and to develop a revised coding strategy. Remediation of infusion system files will also beconducted. The specific complaints cited above involving motor stall and inflammatory mass were rereviewed, and codes were revised if necessary.Your corrective actions appear to be appropriate; however, a followup inspection will be necessary toevaluate implementation and effectiveness.

C) Trending of complaint data/ coding for evaluation was not completed per procedures:(1) Devices that are not returned are trended per the procedure "Complaint and Adverse EvenTrend Reporting" (RPMWI1832). This was not completed for 2011 and 2012 for the followingproducts: infusion systems, neurostimulation for movement disorder (DBS), neurostimulationfor pain, InterStim therapy, Enterra therapy, and Prostiva.

FDA 483 Response: Neuromodulation trended complaint PEs without an associated product return. Yourfirm also developed a new analysis approach to replace the trend "Device not returned, furtherinvestigation not possible without device," previously required by RPMWI1832. An (b)(4) to performstatistical analysis of postmarket surveillance data sources is being implemented.Your corrective actions appear to be appropriate; however, a followup inspection will be necessary toevaluate implementation and effectiveness.

(2) "Known Expected Events" are trended per the procedure Adverse Event Trend Reporting"(RPMWI1832), using a (b)(4) code. Due to a transition to a new complaint handling computersystem, the following complaints were missing an (b)(4) code and were not included in trending:

a. 99 complaints for inflammatory mass including, 500037107,500093511,500082334,500075104,500050731,500095044,500071809,500071678,500054756,500051396,500075527,500039586,500043194,500165916,700069121,500093970,500074339,500166572,500076576,and500081542.b. 88 complaints for Dysarthria. When this data was added to the system, three separatesignals exceeded threshold.c. 11 complaints for Loculation.d. 104 complaints for Incision Pain.


FDA 483 Response: Your firm rereviewed all complaints that were affected by the transition/conversionissue, and missing (b)(4) codes were added to the files. New trending was conducted and resultingsignals were investigated. On a broader scale, data conversion procedures were revised and implementedto address the root cause of the problem.Your corrective actions appear to be appropriate; however, a followup inspection will be necessary toevaluate implementation and effectiveness.

(3) The threshold limit assigned to trends is not described in the procedure "Complaint and AdverseEvent Trend Reporting" (RPMWI1832).

FDA483 Response: Your response states that you updated RPMWI1832 to include instructions for (b)(4)A followup inspection will be necessary to evaluate implementation and effectiveness of this correctiveaction.

D) Data is not evaluated per procedure to determine if signals exist that would require furtherinvestigation.The procedure "Complaint and Adverse Event Trend Reporting" (RPMWI 1832) states "Evaluate thedata and determine if any results meet the signal investigation requirement(s)." This was notcompleted due to incomplete data noted above.

FDA 483 Response: Your response appears to be limited to the incomplete data cited above in 3. C) (2).The scope of this citation, however, is broader. We are concerned that incomplete complaint data andincorrect coding decisions described elsewhere in this letter (e.g., citations 2 and 3) may havecompromised your firm's ability to detect and investigate signals.In response to this letter, please describe the actions that your firm is taking to ensure that you willappropriately detect and investigate all signals.Re: FDA 483 Response to Observations 46: The corrective actions reported and planned appear to beadequate. Implementation and effectiveness will be evaluated during a followup inspection.You should take prompt action to correct the violations addressed in this letter. Failure to promptly correcthese violations may result in regulatory action being initiated by the Food and Drug Administrationwithout further notice. These actions include, but are not limited to, seizure, injunction, and/ or civilmoney penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devicesso that they may take this information into account when considering the award of contracts. Additionally,premarket approval applications for Class III devices to which the Quality System regulation deviationsare reasonably related will not be approved until the violations have been corrected. Requests forCertificates to Foreign Governments will not be granted until the violations related to the subject deviceshave been corrected.We are requesting that you submit to this office on the schedule below, certification by an outside expertconsultant that he/she has conducted an audit of your establishment's manufacturing and qualityassurance systems relative to the requirements of the device Quality System regulation (21 CFR Part820). You should also submit a copy of the consultant's report and your certification that you havereviewed the consultant's report and that your establishment has initiated or completed all correctionscalled for in the report. The initial certifications of audit and corrections and subsequent certifications ofupdated audits and corrections (if required) should be submitted to this office by the following dates:

• Initial certifications by consultant and establishment by January 17, 2013• Subsequent certifications of updated audits and corrections by January 17, 2014, and 2015

Please notify this office in writing within fifteen (15) working days from the date you receive this letterwith an update on the specific steps you have taken to correct the noted violations, including anexplanation of how you plan to prevent these violations, or similar violations, from occurring again.Include documentation of the corrective actions you have taken. If your planned corrections will occurover time, please include a timetable for implementation. If corrective actions cannot be completed within15 working days, state the reason for the delay and the time within which the corrections will becompleted.Your response should be sent to Timothy G. Philips, Compliance Officer, at the address on this letterhead.If you have any questions about the content of this letter please contact Mr. Philips at (612) 7587133.Finally, you should know that this letter is not intended to be an allinclusive list of the violations at yourfacility. It is your responsibility to ensure compliance with applicable laws and regulations administered b


FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483,issued at the closeout of the inspection may be symptomatic of serious problems in your firm'smanufacturing and quality assurance systems. You should investigate and determine the causes of theviolations and take prompt actions to correct the violations and to bring your products into compliance.Sincerely,/s/Michael Dutcher, DVMDirectorMinneapolis District





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http://www.hhs.gov/


EXHIBIT 6


DEPARTMENT OF HEALTH AND HUMANSERVICES*FOOD AND DRUG ADMINISTRATION

DISTRICT ADDRESS AND PHONE NUMBER DATE(S) OF INSPECTION

250 Marquette Avenue, Suite 600 02/14/2013 04/03/2013*Minneapolis, MN 55401 miklumism

(612) 334-4100 Fax:(612) 334-4134 2182207

Industry Information: www.fda.gov/oc/industryNAME AND ITTLE OF INDIVIDUAL TO wHom REPORT ISSUED

TO: Omar S. Ishrak, Chairman and Chief ExecutiVe OfficerRRM NAME STREETADDRESS

Medtronic Neuromodulation 7000 Central Ave NEcITY, STATE, ZIP CODE, COUNTRY T(PE ESTABUSHMENT INSPECTED

Minneapolis, MN 55432-3568 Medical Device Manufacturer

This document lists observations made by the FDA representative(s) during the inspection ofyour facility. They are inspectionalobservations, and do not represent a fmal Agency determination regarding your compliance. Ifyou have an objection regarding an

-observation, or have implemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or

action with the FDA representative(s) during the inspection or submit this information to FDA at the address above. Ifyou have anyquestions, please contact FDA at the phone number and address above.

The observations noted in this Form FDA-483 are not an exhaustive listing ofobjectionable conditions. Under the law, yourfirm is responsiblefor conducting internal self-audits to idenfift and correct any and all violations ofthe quality systemrequirements_

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:

OBSERVATION 1

Products that do not conform to specifications are not adequately controlled.

Specifically,

A) Your firm distributed nonconforming SC catheters, and failures due to the nonconforming products have resulted in

serious adverse events. FroM September 10, 2012 to March 25, 2013, approximately (b) (4) SC catheters that do not confirm

to the current product specifications have been distributed. Regulatory approval was received for Supplement .136 to PMA

P860004 on December 15, 2011 to change the design of SC Catheter models 8709SC, 8731SC, 8596SC, and 8578 to mitigatea known field issue associated with CAPA 1507- SC Catheter Occlusion. This design change was implemented via ECO 12-

00985, dated March 6, 2012, and the new revisions of Catheter models were released to the field in September 2011

HoWever, the previous SC catheter models which do not conform to the current design have continued to be distributed and

have attributed to 60 complaints of catheter occlusion since September 2012.

B) Your firm distributed approximately (b) (4) lead kits containing nonconforming lead caps to the field from 19 NOV 2012

to 29 IAN 2013. On 31 OCT 2012 and 19 NOV 2012, your firm performed testing on the DBS lead cap that showed the

(b) (4) SaaNginkfaNOMOMMIN,CitgraLV.; The prOduct specification contains (b) (4) requirement of

Per your procedure "QMS1340 TLP Escalating Quality Issues and Handling Nonconformances" ver. 9.0 dated 1/11/12, whenEMPLOYEE(S) SIGNATURE DATE ISSUED

E REVERSEJessica L. Johnson, Investigator 4 0".1 t'-) 4,i/4/23

SETHIS PAGEM.

11.7Susan Matthias, Investigatordt;, 04/03/2013

OF /tAilM4r41.- 5( 3.t.

501. MA 483 (09/08) P8EvIOUSEDM094 OBSOLETE, INSPECTIONAL OBSERVATIONS PAGE 1 OF 5 PAGES


.7), DEPARTMENT OF REALTD ANIDDISMAN SERVICESFOOD AND DRUG ADMINISTRATION

DISTRICT ADDRESS AND PHONE NUMBER DATEIS) OF INSPECTION

250 Marquette Avenue, Suite 600 02/14/2013 04/03/2013*Minneapolis, MN 55401

FEI NUMBER

(612) 334-4100 Fax:(612) 334-4134 2182207

Industry Information: www.fda.gov/oc/industryNAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED

TO: Omar S. Ishrak, Chaiiman and Chief Executive OfficerFIRM NAME STREETADDRESS

Medtronic Neuromodulation 7000 Central Ave NEarr. STATE. Z/P CODE, COUNTRY TYPE ESTABLISI IMENTINSPECTED


a product nonconformance is confirmed, the product is to be segregated and place on hold, Ifthe product has been.distributed, the risk assessment decision must be documented within 30 days. The Risk Assessment for DBS Lead CAP

(b) (4) V.W.bei,,,k,.S.32,,A,...L., Issue (GCAPA 145631) was not completed until 28 JAN 2013.

In addition, your procedure also requires an approved product deviation to distribute nonconforming product. A producti deviation for the nonconforming DBS lead kits was not authorized until 07 FEB 2013.

OBSERVATION 2

Procedures for corrective and preventive action have not been adequately established.

Specifically,

(A) Actions needed to correct and prevent recurrence ofa quality problem were identified but not implemented_ For

example,.

(i) Feedthrough CAPA number 10594 identified actions on 02 APR 2008 viaN1111E1148-98756- "Feed

Through Shorting, (b) (4) :;:il•aa Effectiveness Report" to correct and prevent recurrence of

feeddrough shorting resulting in motor stalls in the SynchroMed 11 infusionpump. The recommended

action o (b) oymiakw:40,,:).go. ;vg-gi .t,im has not been implemented. Since April 2008,

at least 298 serious adverse events have resulted from feedthrough shorting.

(ii) CAPA 110407 (b) (4) identified an action within the 21 JUN 2012 Risk

Evaluation Board meeting minutes. The recommended action was (b) (4)The NLT did not approve the

recommendation and delayed any action until the MIA was completed 4ipe.uetittgLu4inev.Htisinspection. Since June 2012, at least 37 serious adverse events have been "possibly" related to the (b) (4)

IIIIICAPA. I

(B) The Health Hazard Assessments for high priority CAPAs with the highest patient severity of death were not completed iEmpunliEmsmwmFe DATE ISSUED

SEE REVERSE

1

Jessica L. Johnson, Investigator <IOF THIS PAGEI FORM_ FDA 453 (09/05)

Susan M. Matthias, Investigator iFt(PREVIMTS EDMON OBSOLETE INSPECTIONAL OBSERVATIONS

1.-- t3,04/03/2013

PAGE2 OF 5 PAGES


DEPART-mit:NT OF HEAT,TH ANDIIUMAN SERVICESFOOD AND DRUG- ADNIDUSTRATION


250 Marquette Avenue, Suite 600 02/14/2013 04/03/2013*Minneapolis, MN 55401 Fe NUMBER

(612) 334-4100 Fax: (612) 334-4134 2182207

Industry Information: www.fda.gov/oc/industryNAME AND TITLE OF INDMDUAL TO WHOM REPORT ISSUED

TO: Omar S. Ishrak, Chairman and Chief Executive OfficerFIRM NAME STREETADDRESS

Medtronic Neuromodulation 7000 Central Ave NECITY, STATE, ZAP CODE, COUNTRY TYPE ESTABLISHMENT INSPECTED


in a timely fashion. Your procedure, QMS1002 TIT Corrective and Preventive Actions requires an IHIA for any high

priority CAPA with a patient risk. For example:

(1) "CAPA 110407 (b) (4) was opened on 01 NOV 2011. The BHA forthis

CAPA was not completed until 11 MAR 13 (during this inspection.)

(ii) "CAPA 132952 (b) (4) was opened 26 June 2012. The HaA was

completed on 01 FEB 13.

(C) Health Hazard Assessments have not been updated after CAPA effectiveness monitoring signaled an increase in the rate

ofoccurrence as evidenced by CAPAs 3064, 7685, and 1507. QMSWI14505 "CAPA Monitoring" states, "Update Health

Hazard Analysis document MEDN-0255, ifrequired by identification ofa new hazard harm and or an increase in severity or

occurrence defined by a change in color on the Risk Index table."

(i) In February 2011, your firm detected a signal in the CAPA 1507 monitor showing .(b) (4);tiThe 13 FEB 2012 High Priority CAPA Board recommended that the BHA for CAPA 1507 "SC Catheter

Occlusion" be updated. The IIRA has not been updated since September 2008. At least 300 complaints for

this CAPA have been received since the MIA was last updated.

(ii) In February 2012, a signal was detected in the CAPA3064 monitor showing a (b (4 qii-,---;TWTOV. The

signal investigation was not completed until February 2013, and the BRA has not been updated since

March 2009. At least 140 complaints for thic CAPA have been received since the HEM was last updated.

(iii) In February 2011, your firm opened a CAPA monitor for CAPA 7685 (b) (4)-44-e.tuvA In December

2011, a decision was made to update the HHA for CAPA 7685; however, the BHA has not been updatedsince September 2010. At least 40 complaints for this CAPA have been received since the BRA was last

updated.

EMPLOYEE(S) SIGNATURE DATE ISSUED

EE REVERSEJessica L. Johnson, Investigator 4-13

SOF THIS PAGESusan M. Matthias, Investigator 04/03/2013

FORM FDA 453 (EWES) pREvioustornatiOBSOLETE INSPECTIONAL OBSERVATIONS PAGE 3 OF 5 PAGES


DEPARTMENT OF REALM AND HUMAN SERVICESFOOD AND DRUG ADMINISTRATION

DIETRICT ADDREES AND PHONE NUMBER DATEM OF INSPECTION

250 Marquette Avenue, Suite 600 02/14/2013 04/03/2013*Minneapolis, MN 55401 mmulmER

(612) 334-4100 Fax:(612) 334-4134 2182207

Industry Infolluation: www. fda gov/oc/industryTAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED

TO: Omar S. Ishrak, Chairman and Chief Executive OfficerFIRM NAME STREETADDRESS

Medtronic Neuromodulation, 7000 Central Ave NECITY, STATE, ZIP CODE. COUNTRY TYPE ESTABLISHMENT INSPECTED


(D) Your firm did not perform a complaint search for CAPA 110407- (b) from December

2011 until our request during this inspection. Your procedure, QMS1861, Corrective and Preventive Action (CAPA)Procedure, versions 11.0 and 12.0 states, "NOTE: The first PE search must take place within 90 days after the CAPA Start

Date...an additional PE search must be performed at least every 90 days during the investigation phase and documented in

the CAPA record."

OBSERVATION 3

Design verification does not confirm that design output meets design input requirements.

Specifically, design verification testing was never performed on the DBS lead cap to verify that the (b)

requirement was met. A total of 103 complaints including 11 serious adveTse events have been reported since the lead cap

was released in May 2006.

OBSERVATION 4

Procedures for design change have not been adequately established.

Specifically, testing was not performed to verify that a design change did not adversely affect the product. Your firm

changed (b) (4) on the DBS lead extensions and lead caps from a (b) (4) to a (b) (4)in January 2011. Seventy-five ofthe 103 complaints regarding connector block twisting and subsequent DBS

lead damage have been reported since the release of the (b) (4) in February 2011.

DAPLOYEEMSMATuW DATEtSSUED

EE REVERSEJessica L. Johnson, Investigator 45:1-C,, 7//3SOF THIS PAGESusan M. Matthias, Investigator, i, 04/03/2013

4-- 4 vaarix--49 4--(73/25FORM FDA 423 (09/03) PREVIOUS/M[110NOBSOLETE INSPECTIONAL OBSERVATIONS PAGE4 OF 5 PAGES

Case 1:16-cv-01682-JEJ Docunieht 1-7 Filed 08/12/16 Page 6 ofI6

h' DEPARTMENT OFIBEAETH AN RiTMAN SERVICESFOOD AND DRUG-ADMINISTRATION


250, Marguette Avenue, Suite 600 02/14/2013 04/03/2013*Minneapolis, MN 55401 FEI NumBER

(612) 334-4100 Fax:(612) 334-4134 2182207Industry Information: www.fda.gov/oc/industryNAME ANDTITIE OF INDIVIDUAL TO WHOM REPORT ISSUED

TO: Omar S. Ishrak, Chairman and Chief Executive OfficerFIRM NAME STREET ADDRESS

Medtronic Neuromodulation 7000 Central Ave NEcrry, STATE, ZIP DOM, COUNTRY TYPE ESTABUSHMENT INSPECTED


al)Pr( Observation Annotations 494/34304,003

Observation Promised to correct Observationji: Promised to correct

Observation;: Promised to correct

Ai 91 3At )412 bre'ryalf IfY) Eilt 1

VV,4

DATES OF INSPECTION:02/1412013(Thu), 02/15/2013Wri), 02119/2013(Tue), 02/2012013(Wed), 02/2212013(Fri), 02125/2013(Mon), 02/26/2013(Tue),02/28/2013(Thu), 03/01/2013(Fri), .03104/2013(Mon), 03/07/2013(Thu), 03/11/2013(Mon), 03/13/2013(Wed), 03/1412013(Thu),03/21/2013(11m), 03/26/2013(Tue), 03/28/2013(Thu), 04/03/2013(Wed)

EmpiarEEmsnumulE DATE ISSUED

(13141).;,C-8C. rr/M4V'ILj 3SEE REVERSE

Jessica L. Johnson, Investigator

OF THIS PAGESusan M. Matthias, Investigator 04/03/2013

FORM FDA AO 019/05) PREVIOUS EDLITON OBSOLETE INSPECTIONAL OBSERVATIONS rAu€ sOFT PAGES

EXHIBIT 7


CASE 0:15-cv-02168-JNE-TNL Document 8 Filed 04/29/15 Page 1 of 27Case 1:16-cv-01682-JEJ Document 1-8 Filed 08/12/16 Page 2 of 28

in the united states district court for the ......2016/08/12 · in the united states district...

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