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	Overheating of Device (1437); Malposition of Device (2616)
Health Effect - Clinical Codes	Burning Sensation (2146); Tingling (2171); Therapeutic Response, Decreased (2271); Discomfort (2330)
Date of Event	09/15/2018
Type of Reportable Event	Serious Injury
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 urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.It was reported that the patient experienced a -burning and stinging at the implantable neurostimulator (ins) site since mid (b)(6) 2018.The patient noted that it went away after a short time, but the sensations returned on (b)(6) 2018 and it seemed worse than before.The burning and stinging continued even when the ins was turned off.There were no reports of trauma or falls that could be related to this issue.In the end, the patient was re-directed to their healthcare professional (hcp) but the patient didn¿t have one that takes their insurance.There were no further complications reported or anticipated.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from the patient.It was reported that the patient found a hcp to remove the device and will install a smaller one on the other side.The circumstances that led to the burning and tingling at the implant site was that the device was close to the surface of the patient's skin.The battery was also coming to its end of life and that caused the tingling sensation.The patient is being careful to avoid the area when dressing/undressing and when using a towel until the device can be replaced.No further complications were reported.

• 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: 8038807
• Report Number: 3004209178-2018-24689
• Device Sequence Number: 19158185
• Product Code: LGW
• UDI-Device Identifier: 00613994842299
• UDI-Public: 00613994842299
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 01/10/2019

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: 11/28/2013
• 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: 11/01/2018
• Supplement Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR