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

Model Number	353101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033)
Date of Event	09/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, information was received from a manufacturer representative and patient regarding a trial patient who was using an external neurostimulator (ens) for urgency frequency and urge incontinence.It was reported that the trial was initiated on (b)(6)2026.It was reported that yesterday they started to have a presumed potential allergic reaction.The caller was not with the patient at the time of the call, but stated the patient called them last night and reported the issue.Agent sent the caller the spec sheets for the lead and extension to caller.The patient (pt) to follow up with managing healthcare provider (hcp).Additional information was received from the patient on (b)(6).The patient stated that they had a rash ever since the procedure.It was unknown if the issue was resolved.On (b)(6) 2026, additional information was received from the patient.It was reported that they were itchy and they had papular rash along their lower back and lead insertion site.They removed the lead and percutaneous extension.The issue was resolved.
Additional Manufacturer Narrative
Continuation of d10: product id 978b128 lot# unknown.Implanted: (b)(6) 2026 explanted: (b)(6) 2026.Product type lead product id 3560022 lot# va3bvy9.Implanted: (b)(6) 2026.Explanted: (b)(6) 2026.Product type extension section d information references the main component of the system.Other relevant device(s) are: product id: 978b128, serial/lot #: unknown.Product id: 3560022, serial/lot #: (b)(6), ubd: 18-aug-2028, udi#: (b)(4).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 ; +1(763)526-5677
• MDR Report Key: 50866092
• Report Number: 2182207-2026-02662
• Device Sequence Number: 18809891
• Product Code: EZW
• UDI-Device Identifier: 00763000879280
• UDI-Public: (01)00763000879280(11)260722(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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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?: No
• 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: 09/18/2026
• Supplement Date Received by Manufacturer: 10/01/2026
• Initial Report FDA Received Date: 09/23/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2026
• 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....".
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 180 LB