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

Model Number 1156T

Device Problems Failure to Capture (1081); High impedance (1291)

Patient Problems Fall (1848); Asystole (4442)

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy pacemaker (crt-p) patient presented to the emergency room after experiencing syncope causing the patient to fall and hit their head.The device was interrogated and found loss of capture on both other manufacturer right ventricular and left ventricular leads.There were observations of fluctuating high impedances and high thresholds causing the loss of capture.Due to the patient condition they did not try to reproduce any noise.The device was reprogrammed to unipolar pace/bipolar sense, and impedance and thresholds came back down.Technical services discussed performing additional troubleshooting focused on clavicular region.The patient had hit their head when they fell and a ct scan was performed, however the patient was doing much better the following day.The device system remains in-service.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: 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: 17527308
• MDR Text Key: 321139993
• Report Number: MW5134241
• Device Sequence Number: 1
• Product Code: NIK
• 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: 11/12/2019

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: 1156T
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1