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

Model Number	353101
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from the patient (pt) regarding a trial external neurostimulator (ens).The reason for the call was the patient reported that last night, after they got home from the hcp's office, they were trying to get out of the recliner chair, they felt a strong tug on the wires (referring to the lead), and they felt a localized pain on the wire, and added that it's sore on the left side.Agent redirected them to the hcp to have the device checked, but the patient keep on insisting to just have it checked by adjusting the therapy setting, stating that if they felt the stimulation on the right spot, then the "wires" probably is just fine.Patient mentioned that they were supposed to increase the stimulation on the right side, which they were able to do last night, and they felt the sensation on the right spot, but what they are worried was the left side, because there's where they feel like the lead got dislodged.Patient wanted to shift therapy on the left side to check if they would feel the stimulation, but they added that they were specifically told by the hcp to not shift sides.Agent reviewed that patient and technical services (pats) can walk them through with the adjustments, but still redirected them to the hcp to further address the issue.Patient then agreed to just contact their hcp.Agent documented reported events.
Additional Manufacturer Narrative
Continuation of d10: product id: neu_unknown_lead, serial# unknown, product type: lead.Section d information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_lead, 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.

• 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: 25219429
• Report Number: 2182207-2026-01325
• Device Sequence Number: 18592348
• Product Code: EZW
• UDI-Device Identifier: 00763000879280
• UDI-Public: (01)00763000879280(11)260302(20)01
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 06/03/2026
• Date Device Manufactured: 03/02/2026
• 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: 62 YR
• Patient Sex: Male