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

Model Number	37714
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a patient regarding an implantable neurostimulator.The reason for call was patient reported their implant battery went bad and the issue began probably in 2019 or 2020 or they didn't remember how long after the implant was implanted that they had issues.Patient stated when they had the implant implanted it was on all the time and it was a very low voltage.There were a couple leads back then that weren't working but they could still use the implant or it was functional.They knew the leads were bad and had been bad for a long time.The implant went bad right before covid and they needed to have the implant replaced as well as the leads that went bad.Patient couldn't deal with the pain with the implant not functioning.The patient was redirected to their healthcare provider to further address the issue.
Additional Manufacturer Narrative
Continuation of d10: product id 39565-65; lot/serial#: (b)(6); implanted: (b)(6) 2013; product type: lead.Section d information references the main component of the system.Other relevant device(s) are: product id: 39565-65; serial/lot #: (b)(6), ubd: 03-may-2017; udi#: (b)(4).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 SENSOR
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: 24741239
• Report Number: 3004209178-2026-05631
• Device Sequence Number: 20246475
• Product Code: LGW
• UDI-Device Identifier: 00613994610430
• UDI-Public: (01)00613994610430(17)140314
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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: 03/14/2014
• Device Model Number: 37714
• Device Catalogue Number: 37714
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 03/31/2026
• Date Device Manufactured: 04/17/2013
• 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 Sex: Male