MAUDE Adverse Event Report: MEDTRONIC PERMANENT PACEMAKER ELECTRODE

Model Number 5524M

Device Problems Pacemaker Found in Back-Up Mode (1440); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This ra lead was implanted on (b)(6) 1996 and remains implanted at this time.A call was placed to technical services on (b)(6) 2018 stating that lead safety switch noted in ra lead.There were lead excursions that appears to be consistent with spring contact.The first excursion occurred on january from the 3 months lead trend.The physician was dr.(b)(6) at (b)(6) cardiology clinic in mason city, ia.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: 17533146
• MDR Text Key: 321376356
• Report Number: MW5140051
• 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: 07/10/2018

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: 5524M
• Patient Sequence Number: 1