MAUDE Adverse Event Report: MPRI VERIFY ENHANCED; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON

Model Number	353101
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Material Deformation (2976)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id 978b128 lot# (b)(6) serial# implanted: (b)(6) 2024 explanted: (b)(6) 2025 product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 978b128, serial/lot #: (b)(6), ubd: 28-mar-2026, udi#: (b)(4) b3: event date is estimated.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 trial patient who was using an external neurostimulator (ens) for urinary/bowel dysfunction/sacral nerve stim and fecal incontinence.It was reported that during the trial the lead slipped.On 2025-jun-16 additional information was received from a healthcare professional (hcp) and the manufacturing representative (rep).The hcp reported that on (b)(6) 2024 the patient had their procedure with their trial and everything was successful.On (b)(6) 2025 the patient complained of abnormal sensations from the device.Fluoroscopy confirmed that their pre-existing stage 1 lead had somehow shifted into an abnormal position where it had curled on itself.The doctor therefore placed a new lead on the left side at the s3 level and tested this new location which seemed better than her previous lead.So, this lead was removed and a new one was placed for the permanent implant.The new implant procedure was done successfully with no issues.

• Brand Name: VERIFY ENHANCED
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; 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: 22281219
• Report Number: 2649622-2025-16455
• Device Sequence Number: 15208554
• Product Code: EZW
• UDI-Device Identifier: 00763000879273
• UDI-Public: 00763000879273
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P080025
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

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 Model Number: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 06/18/2025
• Date Device Manufactured: 07/09/2024
• 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: 48 YR
• Patient Sex: Female