MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA 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	Fluid Discharge (2686)
Date of Event	02/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a trial patient (pt) via a manufacturer representative (rep) regarding the trial pt with an external n eurostimulator (ens).Pt reported to the rep that they noticed clear brown discharge on their pajamas for "the last few days".Rep reports notifying the physician.No troubleshooting was attempted, the cause is unknown and the issue is still ongoing.Rep reported that the cause was unknown.The patient was seen in the clinic and leads were removed.The issue was resolved.
Additional Manufacturer Narrative
Continuation of d10: product id: 977d260, lot# va38tcj043, implanted: (b)(6) 2026, product type: screening device.Product id: 977d260, lot# va38tcj029, implanted: (b)(6) 2026, product type: screening device.Section d information references the main component of the system.Other relevant device(s) are: product id: 977d260, serial/lot #: (b)(6), ubd: 02-feb-2030, udi#: (b)(4); product id: 977d260, serial/lot #: (b)(6), ubd: 02-feb-2030, udi#: (b)(4).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 PUERTO RICO VILLALBA; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MEDTRONIC PUERTO RICO VILLALBA; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 25015477
• Report Number: 2649622-2026-12109
• Device Sequence Number: 10295255
• Product Code: LGW
• UDI-Device Identifier: 00763000586850
• UDI-Public: (01)00763000586850(17)270608(10)NLJ853899N
• Combination Product (Y/N): N
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

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
• Device Lot Number: NLJ853899N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/28/2026
• Date Device Manufactured: 12/30/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female