BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENERGEN

    MDR report key: 3252028 · Received July 29, 2013

    Report

    Report Number
    2124215-2013-11649
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    May 11, 2013
    Report Date
    May 16, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE CASE WAS OPENED AND INTERNAL VISUAL INSPECTION NOTED NO IRREGULARITIES. AN EXTERNAL POWER SOURCE WAS 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SUSPECTED TO EXHIBIT PREMATURE BATTERY DEPLETION (PBD). THE FIELD REPRESENTATIVE REPORTED THE DEVICE TO ONLY SHOW 2.5 YEARS REMAINING LONGEVITY AFTER LESS THAN ONE YEAR OF IMPLANT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REQUESTED DEVICE DATA TO PERFORM A DISK ANALYSIS. ANALYSIS OF THE DATA STORED TO THE DEVICE INDICATED INCREASED POWER CONSUMPTION WITHOUT ANY APPARENT CAUSE. WHILE TS STATED THE DEVICE WOULD BE ABLE TO PROVIDE ADEQUATE THERAPY BEYOND THE SHORT TERM, IT WAS THE PHYSICIAN DISCRETION AS TO WHEN TO REPLACE THE DEVICE. A REVISION PROCEDURE WAS LATER PERFORMED IN WHICH THE DEVICE WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353190 ENERGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E143

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R T165| E143| 4470| 0185