MAUDE Adverse Event Report: ST. JUDE MEDICAL RA LEAD; PERMANENT PACEMAKER ELECTRODE

Model Number 1688T

Device Problems Failure to Capture (1081); Over-Sensing (1438); Ambient Noise Problem (2877); Impedance Problem (2950)

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

Event Type  malfunction  

Event Description

It was reported that this right atrial (ra) lead exhibited noise and oversenslng resulting in inappropriate atrial tachy response episodes, loss of capture and high pace impedance measurements.The physician was going to continue to monitor.The lead remains in senice.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): ST. JUDE MEDICAL
• MDR Report Key: 17530223
• MDR Text Key: 321445008
• Report Number: MW5137143
• 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: 04/01/2022

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: 1688T
• Device Lot Number: DN63557
• Patient Sequence Number: 1