BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2170370 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09924
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    August 20, 2009
    Report Date
    May 31, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A LONGEVITY CALCULATION FOUND THAT THE DEVICE DID NOT MEET LONGEVITY ESTIMATES PROVIDED IN DEVICE LABELING. PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE ISOLATED AND TESTED. FINAL ANALYSIS CONCLUDED THAT THE PREMATURE BATTERY DEPLETION WAS DUE TO LOW-VOLTAGE CAPACITOR DEGRADATION, WHICH RESULTED IN A HIGH CURRENT CONDITION. IT WAS NOTED THAT THE PREMATURE DEPLETION DID NOT MEANT THE SHORTENED REPLACEMENT WINDOW ADVISORY CRITERIA. ANALYSIS WAS UNABLE TO CONFIRM ANY INTERROGATION ISSUE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AT A DEVICE INTERROGATION THREE YEARS AGO THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD A MONITORING VOLTAGE OF 2.65V. FOUR MONTHS LATER THE CLINICIAN RECEIVED AN OUT OF RANGE TELEMETRY MESSAGE AND WONDERED IF THE DEVICE HAD REACHED END OF LIFE (EOL). THE DEVICE WAS INCLUDED IN THE SHORTENED REPLACEMENT WINDOW ADVISORY POPULATION, BUT DID NOT APPEAR TO BE EXHIBITING THE ADVISORY BEHAVIOR AS THE DEVICE REACHED 2.65V AFTER 35 MONTHS OF IMPLANT. TECHNICAL SERVICES DISCUSSED THAT IT WAS UNLIKELY THE DEVICE WOULD HAVE DEPLETED ENOUGH TO BE UNABLE TO BE INTERROGATED IN THAT SHORT A TIME. A MAGNET PLACED OVER THE DEVICE PRODUCED BEEPING TONES, WHICH CONFIRMED THE DEVICE HAD ENOUGH REMAINING BATTERY FOR INTERROGATION. IT WAS THEN NOTED THAT THE PROGRAMMER WAS PLUGGED INTO A POWER STRIP. WHEN THE PROGRAMMER WAS PLUGGED DIRECTLY INTO THE WALL OUTLET, AN INTERROGATION WAS SUCCESSFUL. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS EXPLANTED A YEAR AND A HALF LATER DUE TO NORMAL BATTERY DEPLETION AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE DEVICE CHANGE OUT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR 0185| 4087| T165