MAUDE Adverse Event Report: MEDTRONIC PERMANENT DEFIBRILLATOR ELECTRODES

Model Number 5076

Device Problems Failure to Sense (1559); Loss of Threshold (1633)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This ra lead was implanted on (b)(6)2010 and remains implanted at this time.A product experience report received on (b)(6) 2017 stated that on (b)(6) 2017 there was a loss of sensing and pacing thershold was hig on ra lead.No x-ray confirmation of lead placment in header, physician advised to carry out to determine correct connection.Lead impedance remains within normal limits.Planning for revision procedure.The physician was dr.Peter o'callaghan at university hospita of wales in cardiff , united kingdom.No other information available.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: 17529211
• MDR Text Key: 321050545
• Report Number: MW5136140
• 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: 08/30/2017

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