MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION EXTERNAL NEUROSTIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number	9772501
Medical Device Problem Codes	High impedance (1291); Migration or Expulsion of Device (1395); Therapy Delivered to Incorrect Body Area (1508)
Health Effect - Clinical Code	Inappropriate Device Stimulation of Tissue (4928)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a manufacturer representative (rep) regarding an implantable neurostimulator.The reason for call was rep said they did a trial on a patient and the patient had some impedances that are a little on the high side, but nothing too far out of the ordinary.Rep said they cannot get the patient to threshold unless they brought the stimulation up to like 16-17 million ma, which was unusual.Patient didn't feel stimulation at the site itself, but when they get that high, it was all down the right leg.Representative tested impedance in prone position, when they tested the first time, sitting up the second time.Representative mentioned that contact 4, 11, and 6 have 6,800-7,000ohms , but they were not using those in their programming, all other electrodes were 1000-1300 ohms.Rep to send patient home with lower stimulation and allow patient to increase stimulation, as needed.The issue was not resolved through troubleshooting.The patient was redirected to their healthcare provider to further address the issue.Rep also mentioned the possibility of the lead not in the epidural space.Technical services didn't ask follow up questions.
Additional Manufacturer Narrative
Continuation of d10: product id: 977d160, serial# unknown, product type screening device section d information references the main component of the system.Other relevant device(s) are: product id: 977d160, serial/lot #: unknown, 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.

• Brand Name: EXTERNAL NEUROSTIMULATOR
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 24944606
• Report Number: 2182207-2026-01049
• Device Sequence Number: 21339575
• Product Code: LGW
• UDI-Device Identifier: 00763000586850
• UDI-Public: (01)00763000586850(17)270413
• 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
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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 Model Number: 9772501
• Device Catalogue Number: 9772501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/20/2026
• Date Device Manufactured: 11/07/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Patient Age: 73 YR
• Patient Sex: Male