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

Model Number	37701
Medical Device Problem Codes	Failure to Deliver Energy (1211); Battery Problem (2885)
Health Effect - Clinical Codes	Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)
Date of Event	06/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a patient who was implanted with a neurostimulator for non-malignant pain and chronic low back pain.It was reported that the patient¿s device was not working and the elective replacement indicator (eri) message appeared on the patient programmer (pp) on the day of the report on a non-rechargeable implantable neurostimulator (ins).The patient also reported that she had a return of pain on the day prior to the report, so they wanted to turn the stimulation back on.This was when she saw the eri message.The patient was able to bypass the eri message and turn the therapy back on again; this helped reduce the patient¿s pain, but they could not feel the stimulation sensation.The pp showed that the patient had access to one group and one program; the amplitude was at 10.5 v.In the end, the patient was directed to their healthcare professional (hcp) to discuss the therapy concerns, eri and to discuss device replacement.Additional information was obtained on 2018-oct-09.It was reported that possible factors that could have led to the loss of stimulation would be that they had been blacking out for nearly a year.When they would black out they would just fall.The cause of the blackouts has not been 100% confirmed by their doctors but the doctors believe that the patient's medications contributed because after their medications and dosages were changed, the blackouts reduced, and now the patient was only blacking out every "once in a blue moon".The patient confirmed they had not seen the end of service (eos) message yet.It was noted the patient's house caught on fire so their programmer got burned up in the fire.They still were not feeling stimulation.The patient saw their primary care doctor who referred them to a neurosurgeon.The neurosurgeon is still reviewing the patient's medical history before deciding on if they will replace the patient's device.No further complications were reported or anticipated.

• Brand Name: RESTORE PRIME
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 7951679
• Report Number: 3004209178-2018-22681
• Device Sequence Number: 1643227
• Product Code: LGW
• UDI-Device Identifier: 00613994842299
• UDI-Public: 00613994842299
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2013
• Device Model Number: 37701
• Device Catalogue Number: 37701
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR