BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONTAK RENEWAL 3

    MDR report key: 1201786 · Received October 17, 2008

    Report

    Report Number
    2124215-2008-99949
    Event Type
    Death
    Date Received
    October 17, 2008
    Date of Event
    September 18, 2008
    Report Date
    October 16, 2008
    Manufacturer
    CLONMEL
    Product Code
    NIK
    Removal / Correction Number
    Z47/53-08
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED. THE BOSTON SCIENTIFIC CRM TECHNICAL SERVICES DEPARTMENT ADVISED THAT THE DEVICE WOULD HAVE STORED AN EPISODE IF IT OCCURRED ABOVE THE 180 BPM LOWEST THERAPY ZONE CUTOFF, AND MET DETECTION CRITERIA. TECHNICAL SERVICES ADVISED THAT THE PT MAY HAVE REQUIRED EXTERNAL DEFIBRILLATION DUE TO A RATE JUST BELOW THE RATE CUTOFF, OR FOR ASYSTOLE. THE PHYSICIAN ELECTED TO REPROGRAM THE LOWEST THERAPY ZONE CUTOFF TO 150 BPM, TO ENSURE THAT ALL VT EPISODES WOULD BE DETECTED. THE PHYSICIAN PLANNED TO RE-EVALUATE THE SITUATION IF THE PT RECOVERED, BUT UNFORTUNATELY, THE PT PASSED AWAY. THE DEVICE WAS NOT INTERROGATED POST MORTEM, AND DESPITE SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFO , THE CURRENT STATUS OF THE DEVICE IS UNK. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PT HAD A BAD RUN OF VENTRICULAR TACHYCARDIA (VT). THE DEVICE DELIVERED ANTI-TACHYCARDIA PACING (ATP), WHICH CONVERTED THE PT, BUT THE VT RESUMED. THE DEVICE AGAIN WAS ABLE TO SUCCESSFULLY CONVERT THE PT- THIS TIME BY DELIVERING A SHOCK. ANOTHER VT EPISODE THEN OCCURRED, IN WHICH DELIVERY OF ATP ACCELERATED THE PT'S RHYTHM. THE DEVICE DELIVERED TWO MORE SHOCKS AND THE PT WAS CONVERTED. WHILE IN THE AMBULANCE, THE PARAMEDICS REPORTEDLY DELIVERED FOUR EXTERNAL SHOCKS TO THE PT. A REVIEW OF DEVICE MEMORY FOUND NO EPISODES STORED FROM THE TIME OF EXTERNAL SHOCK DELIVERY, AND NO ELECTROGRAMS WERE AVAILABLE FROM THE TIME THESE EXTERNAL SHOCKS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL 3 IMPLANTABLE CHF GENERATOR NIK CLONMEL H177

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death 0185/(B)(4)| 4480/(B)(4)| 4543/(B)(4)