BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2171270 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-11875
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 6, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT BOSTON SCIENTIFIC'S (B)(4) LABORATORY, A THOROUGH EVALUATION OF THE PRODUCT WAS PERFORMED. AN EXTERNAL POWER SUPPLY WAS CONNECTED TO THE DEVICE AND THE ELECTRICAL CURRENT WAS MONITORED. DURING THE MONITORING PROCESS A HIGHER THAN NORMAL CURRENT DRAIN WAS OBSERVED. IN AN ATTEMPT TO DETERMINE THE CAUSE OF THE HIGH CURRENT CONDITION, ELECTRICAL TESTING AND ANALYSIS WERE CONDUCTED, WHICH ISOLATED THE HIGH CURRENT CONDITION TO AN ANOMALY ON ONE OF THE COMPONENT LAYERS (GATE OXIDE) WITHIN THE DEVICE'S INTEGRATED CIRCUIT. THIS ANOMALY CAUSES A HIGH CURRENT DRAIN, WHICH OVER TIME RESULTS IN PREMATURE BATTERY DEPLETION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT, DURING THE IMPLANT PROCEDURE, IT WAS OBSERVED THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD A BATTERY CONSUMPTION EXCEEDING NORMAL VALUE. A MEMORY DATA DISK WAS SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (BSC TS) FOR REVIEW. BSC TS DISCUSSED THAT THIS DEVICE WILL NOT RECOVER ITS NORMAL BATTERY LEVEL AS THE MEMORY DIAGNOSTIC DATA INDICATED THAT THIS DEVICE ENTERED A HIGH CURRENT CONDITION IN (B)(6) 2011. BSC TS ADVISED TO NOT IMPLANT THE DEVICE, AND TO RETURN THE CRT-D FOR ANALYSIS. A DIFFERENT DEVICE WAS IMPLANTED IN THE PATIENT. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P108

    Patients

    Seq Age Sex Outcome Treatment
    1