BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2153677 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-07575
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CRT-D WAS IMMEDIATELY REMOVED FROM SERVICE. IT WAS ALSO NOTED DURING EXPLANT OF THIS CRT-D, THAT THE ASSOCIATED RIGHT ATRIAL (RA) LEAD WAS OBSERVED TO BE DISCOLORED (YELLOW) AND HAD NO CAPTURE AT MAXIMUM OUTPUT. THIS CRT-D WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. FINAL ANALYSIS CONCLUDED THAT THIS DEVICE WAS RECEIVED WITH NO TELEMETRY. INTERNAL INSPECTION SHOWS ARCING OF THE SECONDARY'S WITHIN THE HIGH VOLTAGE CHARGE TRANSFORMER DAMAGED THE HYBRID. THIS DAMAGE RESULTED IN LOSS OF TELEMETRY AND A HIGH CURRENT DRAIN DEPLETING THE BATTERY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS UNSUCCESSFULLY ATTEMPTED FOR INTERROGATION DURING THE PATIENT'S ROUTINE CLINIC FOLLOW UP. THIS DEVICE HAD BEEN PREVIOUSLY CHECKED ABOUT FOUR MONTHS PRIOR WITH NORMAL FUNCTION AND HAD BEEN ESTIMATED TO HAVE SIX YEARS REMAINING UNTIL EXPLANT. THERE WERE NO REPORTED ADVERSE PATIENT SYMPTOMS BEYOND THE IMMINENT SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention N119| 4136| 0158