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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
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DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO Back to Search Results
Patient Problem Atrial Fibrillation (1729)
Event Type  Injury  
Event Description
It was reported that this right ventricular (rv) lead, part of a recently implanted cardiac resynchronization therapy defibrillator (crt-d) system, exhibited noise with over-sensing, pacing inhibition, and loss of capture (loc) at 3v at 1ms.The signals appeared regularly, and could be over-sensed right atrial (ra) activity.No shocks were delivered, however several bursts of inappropriate anti-tachycardia pacing (atp) and seven diverted shocks were observed in the ventricular fibrillation (vf) zone.In addition, rv pace impedance measurements were in the low 300 ohms range.It was noted that the patient was pacer dependent and in chronic atrial fibrillation (af), however the patient appears to have conduction through the observed noise as well.Technical services (ts) reviewed troubleshooting options and possible causes.Therapy was turned off.Additional information received reported that this rv lead was explanted and replaced.No adverse patient effects were reported.Disclaimer statement: this report reflects information received by fda in the form of a notification per 803.22 (b)(2).Ref report: mw5120226 and mw5120227.
 
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Brand Name
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
Type of Device
DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
MDR Report Key17412784
MDR Text Key320129144
Report NumberMW5120228
Device Sequence Number1
Product Code NIK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 05/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Was Device Available for Evaluation? No
Patient Sequence Number1
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