MAUDE Adverse Event Report: MEDTRONIC RA LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 5086MRI

Device Problems Over-Sensing (1438); Ambient Noise Problem (2877)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the health care professional (hcp) called for a review of an atrial tachy response (atr) episode with this patient with a pacemaker.Technical services reviewed the data and found noise that was being oversensed on both the right atrial (ra) and right ventricular (rv) channel.Both impedance measurements were noted to be stable.Additionally, there was a large fluctuation in rv amplitudes.Technical services informed the hcp to ensure there were no electromagnetic interference (emi) sources and provided some troubleshooting options.At this time, the pacemaker, the ra lead and this rv lead remain in service.No adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RA LEAD
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17489464
• MDR Text Key: 320699140
• Report Number: MW5122005
• 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: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 5086MRI
• Patient Sequence Number: 1