MAUDE Adverse Event Report: ST. JUDE MEDICAL DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number 1458Q

Patient Problem Tachycardia (2095)

Event Type  Injury  

Event Description

It was reported that, the cardiac resynchronization therapy defibrillator (crt-d) system delivered inappropriate atrial tachy response (atr) due to atrial oversensing of the ventricular signal.In these atrs there appears to be loss of capture (loc) on this left ventricular (lv) lead, then the native right ventricular (rv) wave falls into blanking zone causing undersensing on the rv lead, leading into no blanking period to cover of the farfield signal in the atrium.The inappropriate atrs would be mitigated with consistent lv capture.Boston scientific technical services (ts) indicated evaluation of lv threshold versus output is needed.This lv lead remains in service.No adverse patient effects were reported.

• Brand Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): ST. JUDE MEDICAL
• MDR Report Key: 18267417
• MDR Text Key: 329824483
• Report Number: MW5148779
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/19/2023

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?: Yes
• Device Model Number: 1458Q
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention