BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2161536 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07256
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    April 15, 2011
    Report Date
    May 17, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DETAILED ANALYSIS IS BEING PERFORMED ON THIS DEVICE. UPON COMPLETION OF ANALYSIS, THIS REPORT WILL BE UPDATED.

    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. 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT EXHIBITED NOISE ON THE RIGHT VENTRICULAR (RV) LEAD, AS WELL AS A SYNCOPAL EVENT AND SHORTNESS OF BREATH. IT IS BELIEVED THAT DURING A RECENT THRESHOLD TEST ON THE ATRIAL (RA) LEAD, THE DEVICE'S AUTOMATIC CAPTURE PROGRAMMING KICKED IN AND PACED WHEN IT SHOULDN'T HAVE. DOING THIS CAUSED SOME DESYNCHRONY FROM THE ATRIUM TO THE VENTRICLE. THE DECISION WAS MADE TO REPLACE THE RV LEAD. AT EXPLANT, THE RV LEAD WAS FOUND TO BE FRACTURED. BOTH THE RA AND RV LEAD WERE SURGICALLY ABANDONED AND THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR 1290| 4087| 4086| 4135| S403| 4136