MAUDE Adverse Event Report: MEDTRONIC PERMANENT PACEMAKER ELECTRODE

Model Number 5524M

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 08/23/2016

Event Type  malfunction  

Event Description

This ra lead was implanted on (b)(6) 1998 and was capped on (b)(6) 2016 due to lead revision.The physician was dr.(b)(6) at (b)(6) hospital - st mary's campus in rochester, mn.No other information is 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: 17537449
• MDR Text Key: 321368858
• Report Number: MW5144327
• 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: 01/13/2017

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: 5524M
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1