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

Model Number	9772501
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/23/2026
Type of Reportable Event	Serious Injury
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
Information was received from a manufacturer's representative regarding an external neurostimulator neurostimulator.The reason for call was caller reports patient started a trial today and is reporting pain down the right side of the leg "outside of normal".Caller is inquiring if patient can have an mri and reports patient has 2 of the 977a260 leads implanted connected to two extensions that are partially externalized.Agent reviewed mri is not recommended during trial and with components partially outside the body.Additional information was received from manufacturer representative (rep) who reported the cause of the pain was unable to be determined.They reported patient came out of surgery in significant pain and the surgeon ordered an mri however, results were unable to be concluded.The rep stated the impedances were within normal limits and patient's pain was consistent whether stimulation was on or off.The patient is currently admitted in the hospital and awaiting to undergo another mri under anesthesia.The rep reported the devices were removed and discarded by the hospital in order for patient to have the mri.
Event or Problem Description
Rep reported that the patient had an mri the day of the procedure.The image returned, wasn¿t very clear, requiring the doctor to order an mri under anesthesia.Following the second mri, we were told there was no indication of epidural bleeding.We were told, however, that the patient was required to have a separate spine surgery.
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.

• Brand Name: EXTERNAL NEUROSTIMULATOR
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 24546597
• Report Number: 2182208-2026-07971
• Device Sequence Number: 13079397
• Product Code: LGW
• UDI-Device Identifier: 00763000586850
• UDI-Public: (01)00763000586850(17)270608
• 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): 03/19/2026

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?: No
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 03/19/2026
• Date Device Manufactured: 12/30/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Hospitalization
• Patient Age: 81 YR
• Patient Sex: Unknown