BEUDAMED
    FDA Adverse Event Death Summary report: N

    COGNIS

    MDR report key: 1971905 · Received January 27, 2011

    Report

    Report Number
    2124215-2011-01395
    Event Type
    Death
    Date Received
    January 27, 2011
    Date of Event
    December 30, 2010
    Report Date
    February 3, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CRT-D WAS DEACTIVATED, EXPLANTED AND WILL BE RETURNED FOR LABORATORY ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE. ONCE THE DEVICE IS RETURNED AND ANALYSIS COMPLETED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS CRT-D WAS THOROUGHLY ANALYZED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. ALL SEAL PLUGS WERE INTACT AND THE SETSCREWS MOVED FREELY AND WITHOUT ISSUE. THE RV PORT HAD INDICATIVE MARKS THAT THE RV LEAD WAS FULLY INSERTED. MEASUREMENTS WERE THEN TAKEN ON EACH PORT TO ENSURE THEY ARE THE SPECIFIED SIZE AND THAT THE IS-1 PIN HAS PROPER CONTACT WHEN INSERTED. THE PORTS ON THIS DEVICE WERE FOUND TO BE WITHIN SPECIFICATION. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. A REVIEW OF THE DEVICE MEMORY FOUND NO RESETS OR FAULT CODES. REVIEW OF THE MEMORY FOUND MANY RECORDED EPISODES ON THE DAY OF THE PATIENT'S DEATH. UNFORTUNATELY, MANY OF THOSE EPISODES WERE OVERWRITTEN. SEVERAL EPISODES RECORDED PRIOR TO THE PATIENT'S DEATH WERE REVIEWED AND REVEALED THAT THE DEVICE WAS SENSING APPROPRIATELY AND DELIVERING THERAPY AS PROGRAMMED AND DESIGNED. THE PATIENT'S HEART DID NOT ALWAYS RESPOND TO ATP THERAPY BUT SHOCK THERAPY CONVERTED THE ARRHYTHMIA ONCE DELIVERED. THE RECORDED EPISODES WERE IN THE VT ZONE WITH A RATE CUT OFF OF 140 BPM AND PROGRAMMED THERAPY BEING 5 BURST OF ATP FOLLOWED BY 2 HIGH ENERGY SHOCKS. THIS DEVICE WAS SENSING APPROPRIATELY AND WAS DELIVERING THERAPY IN THE CORRECT PROGRAMMED SEQUENCE. LABORATORY ANALYSIS WAS UNABLE TO CONFIRM THE FIELD OBSERVATIONS THAT THE DEVICE WAS NOT OPERATING PROPERLY. ANALYSIS FOUND THAT THIS DEVICE MET ALL SPECIFICATIONS AND WAS OPERATING AS PROGRAMMED AND DESIGNED. IN ADDITION, ANALYSIS OF THE AVAILABLE STORED ELECTROGRAMS WAS UNABLE TO CONFIRM THE FIELD OBSERVATIONS THAT THE DEVICE WAS NOT OPERATING PROPERLY.

    Description of Event or Problem · 1

    THE CRT-D WAS RETURNED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DIED AFTER EXPERIENCING A VENTRICULAR TACHYCARDIA (VT). THE PHYSICIAN REPORTED THAT THE DEVICE WAS EXPERIENCING SENSING PROBLEMS AND ONLY ONE EPISODE OF ANTI-TACHYCARDIA PACING (ATP) AND ONE SHOCK WAS DELIVERED PRIOR TO THE PATIENT'S DEATH. WHEN THE DEVICE OVERVIEW WAS REVIEWED, THIS EPISODE WAS NOT RECORDED. IT IS UNKNOWN IF THE DEVICE FUNCTION CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1 Death