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

Model Number	353101
Medical Device Problem Codes	Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, information was received from a trial patient who was using an external neurostimulator (ens) for urinary dysfunction (incontinence, urgency and or frequency).It was unknown when the trial was initiated.It was reported that the therapy was turned off.Troubleshooting was performed as the patient relaunched the app and turned on the therapy and set the stim to the level where it was before it was turned off.The cause was not known.The issue was resolved.Today, patient reported that the therapy was turned off 45min ago.On 2025-aug-27, additional information was received from the healthcare provider (hcp).Their trial started on (b)(6) 2025.The cause of the therapy being turned off was not determined.The most likely cause/contribution to the issue was noted to be the peripheral nerve evaluation (pne) lead being tugged or inadequate grounding.The issue occurred on the last day of the trial.
Additional Manufacturer Narrative
Continuation of d10: product id: 306001, lot#: unknownserial#, implanted: on (b)(6) 2025, product type: screening device.Section d information references the main component of the system.Other relevant device(s) are: product id: 306001, 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.
Additional Manufacturer Narrative
Continuation of d10: product id: 306001, lot# unknown, implanted: (b)(6) 2025, product type screening device product id: neu_unknown, serial# unknown, product type 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
H3: analysis of the external neurostimulator (ens) (s/n:(b)(6) passed all testing in the laboratory and no anomalies were identified.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: 22960635
• Report Number: 2182207-2025-02291
• Device Sequence Number: 9636421
• Product Code: EZW
• UDI-Device Identifier: 00763000879273
• UDI-Public: (01)00763000879273(11)250430(20)01
• Combination Product (Y/N): N
• 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): 01/09/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 09/04/2025; 01/06/2026
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 09/04/2025; 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Female