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

Model Number	353101
Medical Device Problem Codes	Overheating of Device (1437); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burning Sensation (2146); Fecal Incontinence (4571); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date is approximate.Year is confirmed valid.Section d references the main component of the system.Other medical products in use during the event include: brand name surescan; product id 978b128 (lot: va35knx); product type: 0200-lead; implant date (b)(6) 2026; explant date 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 unknown indications for use.It was unknown when the trial was initiated.It was reported that on 2026-feb-12 the lead was scrapped and reported bowel leakage and burned.They reported leaks, constant mucous, brown moderate and pad.The lead was burned.
Additional Manufacturer Narrative
Continuation of d10: product id 978b128 lot# va35knx.Implanted: (b)(6) 2026: product type lead 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 manufacturer representative (rep).The rep stated that they were writing to clarify the information submitted regarding the registration.There was an image provided to registration team that provided the device sticker to verify the model and lot number.The additional information included on the sheet consisted of patient baseline details and clinical notes, which were not related to the device or the procedure itself.There were no device malfunctions, patient complications, or adverse events associated with this case.The information being requested is non-applicable.Mdr decision corrected to not reportable.No additional supplemental reports are required unless additional information received indicates reportable event.
Additional Manufacturer Narrative
Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event does not meet the reporting requirements stipulated in 21 cfr 803.Note that the h.6.Codes have been updated to reflect the new information.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, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 24433393
• Report Number: 2182208-2026-04431
• Device Sequence Number: 18716562
• Product Code: EZW
• UDI-Device Identifier: 00763000879280
• UDI-Public: (01)00763000879280(11)250725(20)01
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Followup
• Report Date (Section B): 03/03/2026

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: 02/06/2026
• Supplement Date Received by Manufacturer: 02/26/2026; 03/03/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/03/2026; 03/03/2026
• Date Device Manufactured: 07/25/2025
• 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....".; "SEE H11....".; SEE H11...
• Patient Age: 77 YR
• Patient Sex: Female