MAUDE Adverse Event Report: MEDTRONIC PERMANENT PACEMAKER ELECTRODE

Model Number 5076

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); High Sensing Threshold (2574); No Pacing (3268)

Patient Problem Insufficient Information (4580)

Event Date 07/12/2018

Event Type  malfunction  

Event Description

This rv lead was implanted on (b)(6) 2018 and was capped on (b)(6) 2018.In a product experience report receive on (b)(6) 2018.It was reported that this rv lead exhibited noise, oversensing and pacing inhibition with no asystole and high pacing thresholds.The physician was dr.(b)(6) at (b)(6) regional medical center in florence, sc.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: 17533767
• MDR Text Key: 321348801
• Report Number: MW5140671
• 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: 10/17/2018

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: 5076
• Patient Sequence Number: 1