BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3053189 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04885
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE PRODUCT WAS PERFORMED. THE DEVICE HAD NO TELEMETRY UPON RETURN. ENGINEERING CALCULATIONS CONFIRMED THE LONGEVITY OF THIS DEVICE WAS NOT AS EXPECTED. THE DEVICE CASE WAS OPENED. AN EXTERNAL POWER SUPPLY WAS CONNECTED TO THE DEVICE AND THE ELECTRICAL CURRENT WAS MONITORED. DURING THE MONITORING PROCESS A HIGH CURRENT CONDITION WAS OBSERVED. ELECTRICAL TESTING AND ANALYSIS WERE THEN CONDUCTED, WHICH ISOLATED THE HIGH CURRENT TO AN ANOMALY IN AN OXIDE LAYER WITHIN AN INTEGRATED CIRCUIT. THIS ANOMALY CAUSES A HIGH CURRENT DRAIN, WHICH OVER TIME RESULTED IN REPORTED CLINICAL OBSERVATION(S).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT NO DEVICE FAILURE DESCRIPTION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154420 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR 0185| 1888TC| E110