BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 3904264 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-08451
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    November 2, 2007
    Report Date
    April 11, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. THE DEVICE WAS 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. IT WAS NOTED THAT THE DEVICE BATTERY MONITORING VOLTAGE WAS 2.69 VOLTS. THE DEVICE CASE WAS OPENED TO FACILITATE EXAMINATION OF THE INTERNAL COMPONENTS. THE DEVICE BATTERY WAS REMOVED AND REPLACED WITH AN EXTERNAL POWER SOURCE. DETAILED ANALYSIS OF THE DEVICE HYBRID WAS UNDERTAKEN. ANALYSIS DID NOT IDENTIFY ANY CONDITIONS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE IDENTIFIED FAILURE OF THE DEVICE TO MEET THE LABELED LONGEVITY CALCULATION. THE ROOT CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A COMPETITOR RIGHT VENTRICULAR (RV) LEAD CAUSED A LEAD SAFETY SWITCH TO OCCUR WITH THIS PACEMAKER. A TECHNICAL SERVICE CONSULTANT DISCUSSED THE REASONS THAT TRIGGER MODE SWITCHING AND INDICATED THAT IT IS NECESSARY TO CHECK DAILY MEASUREMENTS TO VERIFY ELECTRICAL LEAD MEASUREMENTS AND PERFORM A NEW PACING IMPEDANCE AND THRESHOLD TESTING TO VERIFY LEAD INTEGRITY. THE PACEMAKER WAS EXPLANTED SEVERAL YEARS LATER WITH NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385395 INSIGNIA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1291

    Patients

    Seq Age Sex Outcome Treatment
    1 1291