MAUDE Adverse Event Report: MEDTRONIC PERANENT PACEMAKER ELECTRODE; PERMANENT PACEMAKER ELECTRODE

Model Number 5024

Device Problems Signal Artifact/Noise (1036); Pacing Intermittently (1443); Telemetry Discrepancy (1629)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

This rv lead was implanted on (b)(6) 1999 and remains implanted as of the present.A call placed to technical services on 04/03/2018 stating that this lead exhibited noise.It was noted that it was as telemetry noise (tn).Caller saw pacing spikes on the surface trace but there were gaps on the electrograms.The following physician was dr.(b)(6) 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: PERANENT PACEMAKER ELECTRODE
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17525899
• MDR Text Key: 321408678
• Report Number: MW5132840
• 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: 5024
• Patient Sequence Number: 1