MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION 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 Codes	Cerebrospinal Fluid Leakage (1772); Headache (1880)
Date of Event	05/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a patient (pt) via a manufacturer representative (rep) regarding an external neurostimulator (ens) trial.It was reported the pt had a severe csf headache following trial, went to emergency room and they suspected csf leak.Pt was sent home and was improving, with return of severe headache on (b)(6) so pt went back to the er on (b)(6) where they pulled the trial lead so they could do a blood patch.The lead was explanted and discarded.The issue was resolved with device removal, cause unknown.The rep noted they would submit any new information that became aware of.
Additional Manufacturer Narrative
Section d references the main component of the system.Other medical products in use during the event include: brand name surescan; product id 977d260 (lot: va3a4w0026); product type: 0215-screening device; implant date (b)(6) 2026; explant date (b)(6) 2026.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 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: 25331206
• Report Number: 2182207-2026-01456
• Device Sequence Number: 15912238
• Product Code: LGW
• UDI-Device Identifier: 00763000586850
• UDI-Public: (01)00763000586850(17)270413
• Combination Product (Y/N): N
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2026
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 06/29/2026
• 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
• 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 Age: 36 YR
• Patient Sex: Female