BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 3232017 · Received July 17, 2013

    Report

    Report Number
    2124215-2013-11269
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. IT WAS NOTED THERE WERE DEVICE RESETS WHICH OCCURRED AT OR POST EXPLANT. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. IT WAS CONFIRMED THAT THE DEVICE STOPPED PACING AS A RESULT OF INDUCED HIGH ENERGY OVERSTRESS CAUSED BY THE CAUTERY DURING THE EXPLANT PROCEDURE; THIS RESULTED IN THE DEVICE RESETTING AND THE PACING DROP-OUT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER REACHED ELECTIVE REPLACEMENT TIME (ERT) AND WAS BEING CHANGED OUT. DURING THE PROCEDURE, AS THE PHYSICIAN WAS USING CAUTERY IN THE POCKET, A LOSS OF OUTPUT WAS OBSERVED. THE DEVICE WAS PROGRAMMED TO VOO MODE DURING THE PROCEDURE. WHEN THE CAUTERY WAS STOPPED THE PACING RETURNED AFTER A FEW SECONDS; THERE WAS NO ASYSTOLE GREATER THAN TWO SECONDS. THE ISSUE WAS DISCUSSED WITH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AND POTENTIAL REASONS FOR THE OBSERVATION WERE DISCUSSED, HOWEVER, IT WAS NOTED THAT IT WAS A RARE ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED, AND A NEW GENERATOR WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331415 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1194

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR 4269| K062| 1194| 430-07| 294-09