BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3053336 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04285
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    June 19, 2012
    Report Date
    March 12, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY A THOROUGH PRODUCT ANALYSIS WAS PERFORMED. THE DEVICE WAS SUCCESSFULLY INTERROGATED. THE MEMORY LOG FOUND THAT THE DEVICE HAD A MAGNET APPLIED TO THE DEVICE MULTIPLE TIMES. DURING THIS TIME, THE DEVICE WENT THROUGH NINE RESETS. THE DEVICE WAS CONFIRMED TO BE FUNCTIONING NORMALLY. AS A RESULT, THE CLINICAL OBSERVATION COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE DEVICE HAS SUFFERED MEMORY CORRUPTION IN THE V-TACHY MODE CHANGE LOG WHICH CAUSED THE ERROR LOG AND HALT ON THE PROGRAMMER. THREE PROGRAMMER WERE ATTEMPTED AND WERE ALL UNABLE TO INTERROGATE. CRITICAL THERAPY WAS CONFIRMED TO BE AVAILABLE AND THE DEVICE WAS CONFIRMED TO BE FUNCTIONING APPROPRIATELY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154842 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F110

    Patients

    Seq Age Sex Outcome Treatment
    1