MAUDE Adverse Event Report: MEDTRONIC PERMANENT PACEMAKER ELECTRODE

Model Number 4568

Device Problem High Sensing Threshold (2574)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This ra lead was implanted in 2000 and remains implanted at this time.A call placed to technical services received on may 17, 2017 stated that this lead showed high threshold.All other lead measurements seemed stable.The physician was unknown at universitair medisch centrum utrecht in netherlands.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 PACEMAKER ELECTRODE
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17527652
• MDR Text Key: 321351656
• Report Number: MW5134584
• Device Sequence Number: 1
• Product Code: DTB
• 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: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 4568
• Patient Sequence Number: 1