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); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a trial patient who was using an external neurostimulator (ens) for fecal incontinence.The trial began on (b)(6) 2024.It was reported that the patient was experiencing loss of stimulation and the patient reached max settings.Troubleshooting performed was unknown.The issue resolved was unknown.Additional information was received from health care professional (hcp).They reported that the cause of the max setting was determined to be unknown.They mentioned most likely lead moved away from nerve from normal activities and daily living.To resolve the issue, they attempted switching sides where max setting were reached as well as left it at max setting on (b)(6) 2024.The issue was not resolved and no further action will be taken.To resolve the loss of stimulation was increased on (b)(6) 2024.The issue was not resolved and no further action will be taken.
Additional Manufacturer Narrative
Continuation of d10: product id: 306001, implanted: on (b)(6) 2024, product type: screening device.Section d information references the main component of the system.Other relevant device(s) are: product id: 306001.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: 20769668
• Report Number: 2182207-2024-04645
• Device Sequence Number: 4387921
• Product Code: EZW
• UDI-Device Identifier: 00763000879273
• UDI-Public: 00763000879273
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P080025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/25/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 11/25/2024
• Date Device Manufactured: 05/31/2024
• 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: 57 YR
• Patient Sex: Female