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

Model Number	37701
Medical Device Problem Codes	Break (1069); High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id 3708140; serial# (b)(6).Product type: extension product id 977006; serial# (b)(6).Product type: implantable neurostimulator section d information references the main component of the system.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from a manufacturer's representative (rep) regarding an implantable neurostimulator (ins).The reason for call was the caller indicated that they were in a case to replace the ins and the extension broke.The caller was trying to identify the extension that was connected to the ins and how it was connected to the 3998 lead.The caller reviewed x-ray imaging with the md and described a system that included a 37082 connected to 37081.Tss reviewed information about the possible components.Troubleshooting was not required.The issue was not resolved through troubleshooting.The surgeon will attempt to access the extension so the component can be replaced.Information was received from a healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient (pt) with an implanted neurostimulator (ins).It was reported that pt was scheduled for a battery replacement for normal eri.Hcp carefully cut down to the battery and ensuring not to come in contact with extensions.Upon examination, the extension that was connected to the battery was observed to be coiled tightly, it did not appear to have wires inside.The hcp removed the old battery and placed on the new battery in order to test connections in impedances.This showed a green connection test, but all high impedances (~20,000).After discussion and contacting technical services, the hcp elected to replace the broken extension in an attempt to resolve the issue.The broken extension removed in two pieces, one of which showed frayed wires and the other a clear sheath with no wires inside.A new extension was successfully placed, and the new battery connected.This resolved all connection and impedance issues.
Additional Manufacturer Narrative
Continuation of d10: product id 3708140 serial# (b)(6) product type extension product id 977006 lot# serial# (b)(6) product type implantable neurostimulator h3: analysis of the product id 3708140 serial# (b)(6) found broken conductors: 0-7 6.5cm from proximal end.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: RESTORE PRIME
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO JUNCOS; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO JUNCOS; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 24364149
• Report Number: 3004209178-2026-02576
• Device Sequence Number: 9652432
• Product Code: LGW
• UDI-Device Identifier: 00613994842299
• UDI-Public: (01)00613994842299(17)140414
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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: 04/14/2014
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male