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

Model Number	353101
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id 306001 lot# unknown: product type screening device product id 309201 lot# unknown: product type screening device section d information references the main component of the system.Other relevant device(s) are: product id: 309201, serial/lot #: unknown: 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 representative regarding a trial patient who was using an external neurostimulator (ens) for fecal incontinence.Their trial started on (b)(6) 2026.It was reported that the lead stylet appeared to be damaged when physician pulled the lead out of the protective cover and attempted to insert into the patient.The lead stylet was slightly pulled out from the lead and was noticed that it was bent at the distal part of the stylet.Therefore, the lead could not be used and an extra lead had to be unpacked.Another thing to notice was that it was unclear which lead was damaged- unsure if it was the lead that is included in the 309201 kit with lot #60694174 or the stand alone lead with lot #60676799 as they were already placed down in the surgical field during the procedure.The cause of the issue was unknown.It was unknown whether the issue was resolved.
Additional Manufacturer Narrative
H3: analysis of the lead (lot#: 60694174) revealed that the distal end of the lead was bent.Continuation of d10: product id 309201, lot# 60694174, product type screening device.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: VERIFY ENHANCED
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON
• 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: 24578039
• Report Number: 2182207-2026-00645
• Device Sequence Number: 13069677
• Product Code: EZW
• UDI-Device Identifier: 00763000879273
• UDI-Public: (01)00763000879273(11)250807(20)01
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P970004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 04/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/08/2026
• Date Device Manufactured: 08/07/2025
• 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...."
• Patient Age: 84 YR
• Patient Sex: Male