MAUDE Adverse Event Report: MEDTRONIC PERMANENT PACEMAKER ELECTRODE

Model Number 5076

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Pacing Intermittently (1443)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This lead was implanted on (b)(6) 2003 and remains implanted at this time.This patient attended a routine follow-up on (b)(6) 2013 and on interrogation, when egms were reviewed noise was seen.The noise resulted in oversensing and pacing inhibition of less than 2sec in all available egms.Reprogramming has resolved this issue with no asystole greater than 2 seconds.The physician was dr.(b)(6) at (b)(6) hospital in (b)(6), united kingdom.No additional information is submitted.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: 17529024
• MDR Text Key: 321417119
• Report Number: MW5135953
• 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: 06/17/2013

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: 5076
• Patient Sequence Number: 1