MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO RESTORE SENSOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37714

Device Problems Battery Problem (2885); Charging Problem (2892); Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Fever (1858); Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Injury (2348); Deformity/ Disfigurement (2360); Numbness (2415); Cognitive Changes (2551); Alteration In Body Temperature (2682); No Code Available (3191)

Event Date 01/01/2013

Event Type  Injury  

Event Description

The consumer reported that the patient was having issues with his implantable neurostimulator (ins).It was later reported that the patient had ins pocket pain radiating to his groin / belly area and shoulder pain.It was also reported that the patient had a fever and it felt like his body was on fire.The reported symptoms started in 2015, occurring on and off.These symptoms were considered a gradual change in therapy/symptoms.The patient further reported that these symptoms subsided two days ago ((b)(6) 2016) and the patient decided to go on vacation.But, the pain returned and the patient had gone to the emergency room (er) yesterday ((b)(6) 2016).It was noted that the patient was told he could not have an mri, and the physician sent the patient home.It was also reported that the patient had not seen any physicians and was putting his symptoms aside as he was the sole caretaker for his daughter.Additional information received from the consumer on (b)(6) 2016 reported that the patient was still experiencing pain and burning sensations; the er had not wanted to do anything for the patient due to the ins.It was noted that the patient was still not home and he needed to fly back home.The patient had a service dog, so it had taken some time to make arrangements to get home.In addition, the patient was unable to drive due to the pain.The patient had a scheduled appointment on (b)(6) 2016 to see his primary care nurse practitioner; they will have a manufacturer representative at the appointment to check the ins.The patient also reported the ins was not holding a charge as long as before; this started about the last couple of weeks.It was noted that the patient was able to charge the ins as usual.The patient's indications for use included spinal pain.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from an attorney representing an individual who claims to have suffered unspecified breach of warranty damages due to what is alleged to be a ¿defective stimulator.¿ the attorney further claimed the patient was told the implantable neurostimulator (ins) had a ¿9-year device life,¿ and further claims the ins ¿failed well before the expiration of nine years.¿.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id (b)(4) lot# serial# nka(b)(4) implanted: explanted: product type recharger if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a legal representative of the patient regarding a patient implanted with an implantable neu rostimulator (ins) for reflex sympathetic dystrophy syndrome to control their pain.It was reported in january 2013 the device stopped accepting a charge and the patient began to experience a burning sensation from the implant location in to their neck and right groin.The patient also lost feeling in their right leg.It was noted the device caused the patient to have spontaneous orgasms.The device worked as warranted for approximately eight months, and then failed.Initially the patient was charging their implant every two weeks.The device stopped charging completely due to the recharger unit became unresponsive and non-functional.A company representative unsuccessfully attempt to remedy the charging issue.The ins malfunctioned, was dangerous, unfit, and was not reasonably safe for its intended use.The ins was considered defective as the material deviated from the fda-approved manufacturing specifications.The patient incurred: personal injuries, physical pain, mental anguish, disfigurement, and physical impairment.No further complications were reported or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the patient through a legal representative reported they experienced burning at the device site, spontaneous orgasms, loss of feeling in their right leg, and new pain in their right groin.It was also reported the patient¿s battery had stopped charging approximately eight months after implant.It was noted the date of defect was (b)(6)2013 and that the patient¿s ins was explanted on (b)(6)2017.No further complications were reported or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a legal representative of the patient reporting that the company representative¿s effort to reprogram the device failed.The patient was advised that the device was recalled because of problems with charging the battery.

• Brand Name: RESTORE SENSOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 5822361
• MDR Text Key: 50454921
• Report Number: 3004209178-2016-14931
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2013
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/04/2016
• Initial Date FDA Received: 07/26/2016
• Supplement Dates Manufacturer Received: Not provided; 06/14/2017; 06/14/2017; 06/14/2017; 10/20/2017; 11/08/2017
• Supplement Dates FDA Received: 08/26/2016; 07/12/2017; 07/12/2017; 09/24/2017; 11/15/2017; 12/06/2017
• Date Device Manufactured: 03/20/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR