BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY

    MDR report key: 1864185 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16092
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 5, 2010
    Report Date
    September 10, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1192-06 THRU Z-1194-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN TESTING IS COMPLETE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    DEVICE REPLACEMENT IS PLANNED, HOWEVER, RECORDS INDICATE THAT THIS DEVICE REMAINS IN SERVICE. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED END OF LIFE (EOL) AFTER EXPERIENCING ONE CHARGE TIME GREATER THAN 30 SECONDS. THE OBSERVED RATE OF BATTERY USAGE WAS COMPARED TO THE EXPECTED RATE OF BATTERY USAGE; THE RESULTS INDICATED THAT THE MONITORING VOLTAGE WAS NORMAL. ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, EOL WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE.

    Description of Event or Problem · 1

    ANALYSIS OF THIS DEVICE IS NOW COMPLETE.

    Description of Event or Problem · 1

    THIS DEVICE HAS BEEN EXPLANTED AND RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE TRIGGERED THE END OF LIFE (EOL) INDICATOR DUE TO CHARGE TIME MEASUREMENTS OF MORE THAN 30 SECONDS AND A BATTERY VOLTAGE OF 2.67 V, AS DISCOVERED VIA A RED ALERT FROM THE LATITUDE SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T180

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 4472| T180| 0185