BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENERGEN

    MDR report key: 2780203 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12490
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 7, 2012
    Report Date
    October 2, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TEN DAYS LATER THE DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE'S INTERNAL DIAGNOSTICS INDICATED THAT THE BATTERY VOLTAGE WAS LOWER THAN EXPECTED. THE DEVICE CASING WAS THEN OPENED AND AN INTERNAL VISUAL INSPECTION NOTED NO IRREGULARITIES. AN EXTERNAL POWER SOURCE WAS THEN CONNECTED TO THE DEVICE AND INTERNAL MEASUREMENTS NOTED A HIGH CURRENT DRAIN. FURTHER DETAILED TESTING ISOLATED THE PROBLEM TO A DEGRADED TANTALUM CAPACITOR THAT PREMATURELY DEPLETED THE BATTERY.

    Additional Manufacturer Narrative · 1

    ONCE THE DEVICE IS EXPLANTED, IT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IMPLANTED FIVE MONTHS AGO AND IS NOW NEARING ELECTIVE REPLACEMENT INDICATOR (ERI) AND SHOWING ONE YEAR LONGEVITY REMAINING. PACING OUTPUTS WERE PROGRAMMED LOW AND THE PATIENT HAS ONLY RECEIVED ONE SHOCK AND ONE EPISODE WITH ANTI-TACHYCARDIA PACING (ATP). THE DEVICE IS USING A HIGH PERCENT OF POWER COMPARED TO NOMINALS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE DEVICE IS EITHER LEAKING CURRENT OR OTHERWISE DRAINING THE BATTERY FASTER THAN IT SHOULD AT THE GIVEN OPERATING PARAMETERS AND RECOMMENDED A DEVICE REPLACEMENT. A DEVICE MEMORY DOWNLOAD WAS PERFORMED. ENGINEERING ANALYSIS CONFIRMED THAT STARTING SOMETIME IN (B)(6) 2012, THIS DEVICE BEGAN EXPERIENCING AN ELEVATED AND ABNORMAL POWER DRAW. NORMAL IMPEDANCES AND REASONABLE PACING AMPLITUDES WERE NOTED, HOWEVER THE DEVICE IS NOT FUNCTIONING APPROPRIATELY. ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE, HOWEVER CONFIRMED THE POWER LEVELS WERE INCREASING SLOWLY AND THE PROJECTED REMAINING LONGEVITY WAS ACCURATE. ENGINEERS RECOMMEND REPLACEMENT AS ABRUPT CHANGES IN THE BEHAVIOR COULD THREATEN THE DEVICE'S ABILITY TO DELIVER THERAPY.

    Description of Event or Problem · 1

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    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 0293| MISMATCH| S606| E142