MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA SPECIFY SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	977C165
Medical Device Problem Codes	Break (1069); Environmental Compatibility Problem (2929); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Information was received from a manufacturer representative (rep) regarding a patient (pt) with an implantable neurostimulator (ins).Manufacturer representative (rep) called to report they were just notified that a neurosurgeon "nicked" a paddle lead with a bovie.Caller said there was no rep at this surgery, but a rep happened to be in a case next door and they did an impedance check.The impedance check was "fine." caller said the nick was "visible" and they were worried about erosion, so they suggested the surgeon replace the lead.Caller currently on their way to the case.Caller wanted to know if there was any documentation about this kind of incident happening/if lead should be replaced.Caller said they got all of this information secondhand.Caller did not have any patient information and wasn't at the hospital where this was all happening.Agent reviewed with caller that guidelines written for intact, non-damaged systems.Agent reviewed that caller's recommendation was made with patient' s safety as first priority and it was fair and conservative.No symptoms were reported.
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 they were not in this case and do not patient information or any additional information and repeated how a hcp had contacted them.
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
Additional information from the rep indicated that there is no plan to explant the lead, as it is still in use.The rep stated that they were not in the operating room at this time but received a call from a staff member the doctor hit the lead with bovie.The lead was impeding his ability to perform complex spine surgery.An impedance check was performed.The lead was implanted.

• Brand Name: SPECIFY SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC PUERTO RICO VILLALBA; road 149 km 56.3; villalba,pr MN 00766
• Manufacturer (Section G): MEDTRONIC PUERTO RICO VILLALBA; road 149 km 56.3; villalba,pr MN 00766
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 23782806
• Report Number: 2182207-2025-03383
• Device Sequence Number: 10116527
• Product Code: LGW
• UDI-Device Identifier: 00643169464599
• UDI-Public: (01)00643169464599(17)240302
• 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
• 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): 04/16/2026

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: 03/02/2024
• Device Model Number: 977C165
• Device Catalogue Number: 977C165
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 03/18/2026; 03/20/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 03/20/2026; 04/16/2026
• Date Device Manufactured: 03/02/2020
• 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
• Patient Age: 63 YR
• Patient Sex: Female