MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO VILLALBA INTERSTIM; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number	3889-28
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Additional information was received from the manufacturer representative (rep).The rep reported that the most likely cause of the patient no longer feeling stimulation was the result of the battery reaching end of service (eos), as determined by the patient's hcp.When the hcp interrogated the battery, the patient didn't mention anything to the hcp about being involved in a car accident.The patient stated that prior to the car accident, their symptoms had started to return, which was attributed to the battery life.The rep stated the patient had their battery replaced on (b)(6) 2025, and the impedances were within normal limits.The patient felt no sensation post-op when therapy was turned on (tested up to 8.0 ma).The rep followed up with the patient 48 hours later and they were still not feeling sensation and it was at this time the patient shared they were involved in a car accident in (b)(6).The rep stated an anteroposterior (ap) and lateral x-ray were ordered by the patient's hcp, and the patient had a follow-up appointment scheduled with their hcp on (b)(6) 2025.The rep stated, the cause of therapy not working was the result of the battery reaching eos, and the x-rays were ordered to rule out a lead migration from the car accident.Additional information was received from a manufacturer representative (rep).The rep reported that x-ray demonstrates lead migration.Health care provider (hcp) believes this is related to a car accident in (b)(6) 2025.Patient was scheduled for lead revision on (b)(6) 2025.
Additional Manufacturer Narrative
Continuation of d10: product id 3058, lot# serial# (b)(6), implanted: (b)(6) 2020, explanted: (b)(6) 2025, product type implantable neurostimulator.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: INTERSTIM
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• 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: 22460434
• Report Number: 2649622-2025-18513
• Device Sequence Number: 20990883
• Product Code: EZW
• UDI-Device Identifier: 00643169864436
• UDI-Public: (01)00643169864436(17)230829(10)VA2257J
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P080025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/09/2025

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 Expiration Date: 08/29/2023
• Device Model Number: 3889-28
• Device Catalogue Number: 3889-28
• Device Lot Number: VA2257J
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 07/09/2025
• Date Device Manufactured: 08/29/2019
• 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: 64 YR
• Patient Sex: Female