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

Model Number	353101
Medical Device Problem Codes	Break (1069); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: implanted: (b)(6) 2026: serial# implanted: (b)(6) 2026: product type lead section d information references the main component of the system.Other relevant device(s) are: 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 unknown indications for use.Their trial started on (b)(6) 2026.It was reported that the wire detached.There was migration/lead moved/wire moved.It was unknown whether there a connector migration.It was unknown whether the product migrate around or entangle internal organs.Patient mentioned the wires were pulled but no bleeding.There was broken lead/lead damaged/lead cut.The cause of the issue was unknown.Troubleshooting was not performed.The issue was not resolved and was ongoing.
Additional Manufacturer Narrative
Continuation of d10: product id 306001 lot# 60683031 serial# implanted: (b)(6) 2026, explanted: (b)(6) 2026, product type screening de vice product id 309201 lot# 60705072 serial# implanted: (b)(6) 2026, explanted: (b)(6) 2026, 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.
Event or Problem Description
Additional information was received from the health care professional (hcp).The hcp stated that the cause of the lead broken was determined.The most likely cause of the event was due to that they dropped the part of the device.When asked about the steps taken to resolve the issue, the hcp stated that the lead removal visit was supposed to be on (b)(6) 2026, but they moved it to (b)(6) 2026 due to fatigue the lead removal was planned on (b)(6) 2026 as per patient's choice.The issue was not yet resolved.When asked about the steps taken to resolve the lead migration, the hcp stated that the lead removed on (b)(6) 2026.The issue was not yet resolved.
Additional Manufacturer Narrative
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: 24869543
• Report Number: 2182207-2026-00984
• Device Sequence Number: 21070765
• Product Code: EZW
• UDI-Device Identifier: 00763000879280
• UDI-Public: (01)00763000879280(11)260129(20)01
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2026
• Supplement Date Received by Manufacturer: 04/14/2026; 04/21/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 04/17/2026; 04/28/2026
• Date Device Manufactured: 01/29/2026
• 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: 64 YR
• Patient Sex: Female