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

Model Number 5076

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 this right atrial (ra) lead and the right ventricular (rv) lead, underwent a system revision due to oversensed noise on both channels.Pacing inhibition with creator than 2 seconds of asystole was observed.It was noted that this pacemaker was implanted subcutaneously.The leads were tested on the pacing system analyzer (psa), however the reported noise was not reproducible and lead measurements were within normal limits.The leads were surgically abandoned and replaced.No additional 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: 17489439
• MDR Text Key: 320699557
• Report Number: MW5121984
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 5076
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1