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

Model Number	353101
Medical Device Problem Codes	Break (1069); Display or Visual Feedback Problem (1184); Failure to Interrogate (1332); Stretched (1601); Communication or Transmission Problem (2896)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a consumer via a manufacturer¿s representative regarding a patient who was implanted with an implantable neurostimulator (ins) for urge incontinence, urgency frequency.The trialstarted on (b)(6) 2024.It was reported that there was a communication issue between the controller and ens. patient kept hitting retry and turned the therapy off then back on.Nothing helped resolved the issue and the communication error that showed stated that the device was not set up correctly.Cause was not determined.Patient reported pain and discomfort/soreness/pinching.The issue was ongoing. patient's device is giving a communication error message.Tapping retry will not work.The rep reported the right sided pne lead was broken just a few mm outside of skin at needle entry point.There was some stretching at skin sight, but lead was hanging,coiled tightly, still plugged into the red pt cable connection.Dressing was original one from one insertion and intact.Pt denies any blunt or shearing force at entry site.Cause was not determined.The issue was confirmed resolved.
Additional Manufacturer Narrative
Continuation of d10: product id: 306001, lot# unknown, 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: unknown , udi#: 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.
Additional Manufacturer Narrative
H3: analysis of the lead (lot#: unknown) revealed that the lead was returned segmented; however electrical testing of the returned s egment(s) determined that continuity was complete and there were no electrical shorts between the circuits.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 a manufacturer representative (rep).The rep reported that the steps taken to resolve the issue included the leads being removed.The issue was resolved.
Additional Manufacturer Narrative
H3: analysis of the ens s/n: (b)(6) revealed that the returned device passed all testing in the laboratory and no anomalies were identified.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: 19830932
• Report Number: 2182207-2024-03256
• Device Sequence Number: 12790051
• Product Code: EZW
• UDI-Device Identifier: 00763000344573
• UDI-Public: 00763000344573
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2024

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?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 08/02/2024; 09/13/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 08/30/2024; 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2023
• 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: 64 YR
• Patient Sex: Male