MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNIPOLAR LEAD KIT; INTESTINAL STIMULATOR

Catalog Number 4351-35

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2023

Event Type  malfunction  

Event Description

Implantation medtronic enterra unipolar lead kit for gastric electrical stimulation.Lead malfunction and broke apart in patient.All components of the lead were removed from the patient.

• Brand Name: UNIPOLAR LEAD KIT
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; minneapolis MN 55432
• MDR Report Key: 17923601
• MDR Text Key: 325732124
• Report Number: MW5146848
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/05/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 4351-35
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/11/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic