BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 3212487 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09367
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 14, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATE ONCE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE PRODUCT WAS PERFORMED. THE MEASURED BATTERY VOLTAGE WAS LOWER THAN EXPECTED; ENGINEERING CALCULATIONS CONFIRMED THE DEVICE FELL SHORT OF LONGEVITY EXPECTATIONS BASED ON ACTUAL CLINICAL USE. 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 HIGHER THAN NORMAL CURRENT DRAIN WAS OBSERVED. ELECTRICAL TESTING AND ANALYSIS OF THE INTERNAL COMPONENTS WERE THEN CONDUCTED, WHICH ISOLATED THE HIGH CURRENT CONDITION TO AN ANOMALY ON ONE OF THE COMPONENT LAYERS (GATE OXIDE) WITHIN THE DEVICE¿S INTEGRATED CIRCUIT. THIS ANOMALY CAUSES A HIGH CURRENT DRAIN, WHICH OVER TIME RESULTS IN PREMATURE BATTERY DEPLETION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A YELLOW ERROR SCREEN UPON INTERROGATION THAT DISPLAYED 'VOLTAGE TOO LOW FOR REMAINING CAPACITY, FC 1003' MESSAGE. THE HEALTH CARE PROFESSIONAL (HCP) CALLED INTO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AND A DEVICE MEMORY DOWNLOAD WAS PERFORMED AND REVIEWED. FOLLOWING THE REVIEW OF THE DEVICE MEMORY ANALYSIS IT WAS DETERMINED THE DEVICE WOULD BE REPLACED DUE TO THE CONFIRMATION OF THE FAULT CODE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314471 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E142

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R E142| 0296| 4136