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

Model Number 1688TC

Device Problems 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 the cardiac resynchronization therapy defibrillator (crt-d) and this non-boston scientific right atrial (ra) lead exhibited oversensing of noise and intermittent increases in pacing impedance measurements.The noise was felt to be consistent with oversensing related to the minute ventilation feature.The patient was noted to be zero percent paced in the ra.Boston scientific technical services (ts) recommended programming the respiratory rate trend feature off and continue monitoring.No adverse patient effects were reported.The device remains in service.It was additionally reported that the respiratory rate trend (rrt) feature is still on at the moment.Boston scientific technical services (ts) discussed programming options and the healthcare professional will continue to monitor.No adverse patient effects were reported.The device remains in service.It was additionally reported that the this non boston scientific right atrial (ra) lead was still exhibiting variable impedance measurements, which was believe to be caused by spring contact issue.Ts discussed programming options and the healthcare professional will continue to monitor.No adverse patient effects were reported.The device remains in service.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: 17488688
• MDR Text Key: 320687348
• Report Number: MW5121387
• 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: 11/25/2022

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: 1688TC
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1