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); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146); Discomfort (2330); Insufficient Information (4580)
Date of Event	02/01/2021
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
It was reported that the patient feels the wires in their stimulator and a pain sensation, but does not know if sensation is with ins off.Per caller, this sensation started to occur about 10 days ago.Rfc was to speak with mdt rep to meet with patient.This was after hours call - provided nas phone number.Caller asked if patient can call this number and then provided pss phone number for patient.The caller was very difficult to understand due to heavy accent so the name of caller is likely not spelled correctly.Was able to confirm managing hcp and caller works for hcp. patient reported having problems with stimulator, setting goes to opposite direction when they are increasing stimulation since two weeks ago and they noticed since having covid-19 shot they were having heat around the ins and it hurts since two weeks ago.Patient asked to meet with a mdt representative (rep) to check implant.The patient was redirected to their healthcare provider to further address the issue.Additional information was received from the patient and it was reported that they felt the implant was warm and under it something was not right, sore.The patient's hcp gave them the number f or a rep but so far no one has contacted them.
Event or Problem Description
Additional information was received from the patient and it was reported that the hcp ran blood tests and after three days called the patient and put them on antibiotics.There was no infection this time.At the moment they feel better but would still like to meet with a rep.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• 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: 11509394
• Report Number: 3004209178-2021-04464
• Device Sequence Number: 3997577
• 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: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

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: 01/28/2015
• 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: 03/15/2021
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR