MAUDE Adverse Event Report: MEDTRONIC PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 5076

Device Problems Failure to Capture (1081); Failure to Sense (1559)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the lead was explanted due to failure to capture and failure to sense.No additional adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PERMANENT DEFIBRILLATOR ELECTRODES
• Type of Device: PERMANENT DEFIBRILLATOR ELECTRODES
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17531766
• MDR Text Key: 321384877
• Report Number: MW5138678
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2021

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?: No
• Device Model Number: 5076
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1