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

Model Number	37714
Medical Device Problem Codes	Break (1069); Connection Problem (2900)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the manufacturer representative (rep) reports that the doctor contacted him on friday to report that they did an ins replacement on (b)(6) 2023.Dr reports that they had trouble removing the lead from the old ins and then they had trouble inserting the lead into the new ins.Dr thinks the lead contact was "crushed".Dr reports that they were unable to insert the lead all the way into the new ins and the last contact is outside the ins header.Rep said the dr is not planning on replacing the lead.Rep did not have the patient (pt) information at time of call to technical services (ts).
Additional Manufacturer Narrative
Section d references the main component of the system.Other medical products in use during the event include: brand name lead; product id neu_unknown_lead (serial: unknown); product type: 0200-lead; 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.
Additional Manufacturer Narrative
Continuation of d10: product id 39565-65 serial# (b)(6) implanted: (b)(6) 2013 product type lead product id 977006 serial# (b)(6) implanted: (b)(6) 2025 product type implantable neurostimulator 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
Additional information was received from the manufacturer representative (rep).It was reported that the cause of the crushed electrodes was unknown.Physician attempted to restore, crushed contact to allow passage into ins.Physician was unable to restore, damaged contact.They were remains an exposed contact outside of the battery.Patient was made aware of the situation.No further intervention is planned by the physician at this time.
Additional Manufacturer Narrative
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
The rep reported the previous ins was discarded by the facility per their policy, and no return will be possible.

• Brand Name: RESTORE SENSOR
• 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 MN 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO JUNCOS; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 23144728
• Report Number: 2182207-2025-02560
• Device Sequence Number: 9284624
• Product Code: LGW
• UDI-Device Identifier: 00613994610430
• UDI-Public: (01)00613994610430(17)131228
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/28/2013
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 11/14/2025; 12/02/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 11/17/2025; 12/03/2025
• Date Device Manufactured: 02/05/2013
• 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....".; SEE H11...
• Patient Age: 78 YR
• Patient Sex: Male