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); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id 306001 lot# unknown serial# implanted: explanted: product type screening device product id 309201 lot# unknown serial# implanted: explanted: product type screening device product id 306001 lot# unknown serial# implanted: explanted: product type screening device product id 309201 lot# unknown serial# implanted: explanted: 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, ubd: , udi#: ; product id: 309201, serial/lot #: unknown, ubd: , udi#: ; product id: 306001, serial/lot #: unknown, ubd: , udi#: ; product id: 309201, serial/lot #: unknown, ubd: , udi#: 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 trial patient who was using an external neurostimulator (ens) for urgency frequency and urge incontinence.It was noted that the patients trial started on 2024-mar-04.It was reported that the patient had intermittent, difficult, or sporadic communication.Additional information was received on 2024-mar-09 , patient ens battery needs to be replaced.Additional information was received from the patient's healthcare provider (hcp).It was reported that the cause of the intermittent communication was determined to be due to the pne leads were completely removed by the patient during the trial.Patient has a history of dementia.They were seen on 2024-mar-11 and decided not to proceed with permanent implant.

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 19219881
• Report Number: 2182207-2024-02449
• Device Sequence Number: 8194741
• Product Code: EZW
• UDI-Device Identifier: 00763000640491
• UDI-Public: 00763000640491
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 05/01/2024

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: 04/09/2024
• Initial Report FDA Received Date: 05/01/2024
• Date Device Manufactured: 09/04/2023
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 60 KG