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

Model Number 353101

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Flatus (1865); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/10/2024

Event Type  Injury  

Event Description

Information was received from a trial patient who was using an external neurostimulator (ens) for fecal incontinence and urge incontinence.It was noted that the patients trial started on (b)(6) 20240.It was reported that patient stated that she accidentally cut their lead.Additional information was received on 2024-apr-12, patient reported that she went to the or to have their leads reconnected.Additional information was received on 2024-apr-19, patient stated that they would have gas before their bowel movements.Additional information was received on 2024-apr-21, patient stated that they experiences gas when they have to have a bowel movement.

Manufacturer Narrative

Continuation of d10: implanted: on (b)(6) 2024 : product type lead section d information references the main component of the system.Other relevant device(s) are: 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received from a healthcare professional (hcp).The hcp reported that the patient cut the lead themselves because they though it was a dress tag.The steps taken to resolve the issue were that on 2024-aor-11 they did a removal/revision for replacement of lead wire only.They confirmed the issue was resolved.

• Brand Name: VERIFY ENHANCED
• Type of Device: 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: 19185575
• MDR Text Key: 341692945
• Report Number: 2182207-2024-02404
• Device Sequence Number: 1
• Product Code: EZW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/20/2024

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
• Device Operator: Health Professional
• Device Model Number: 353101
• Device Catalogue Number: 353101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/10/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/20/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 89 KG