BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1861041 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-15353
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    July 29, 2010
    Report Date
    October 19, 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 Location
    ME
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETURN TO BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY, A REVIEW OF DEVICE MEMORY REVEALED THE DEVICE DECLARED ITS END OF LIFE INDICATOR (EOL) AFTER EXPERIENCING A CHARGE TIME GREATER THAN THE EOL 30-SECOND CHARGE TIME LIMIT. ADDITIONAL LAB ANALYSIS AND TESTING SHOWED EOL WAS TRIGGERED EARLIER THAN EXPECTED DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF DEVICE INTERNAL BATTERY IMPEDANCE. ANALYSIS CONFIRMED THAT ALL THERAPIES WERE AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE SUBSEQUENTLY WAS EXPLANTED AND REPLACED WITH NO ADVERSE PATIENT EFFECTS. THE DEVICE'S REPORTING STATUS IS CHANGED TO SERIOUS INJURY FROM MALFUNCTION DUE TO EXPLANT WITH AN EARLY REPLACEMENT INDICATOR SUSPECTED.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM A BOSTON SCIENTIFIC FIELD REPRESENTATIVE THAT THIS DEVICE DISPLAYED AN END OF LIFE (EOL) BATTERY STATUS INDICATOR ASSOCIATED WITH A MIDDLE OF LIFE 2 BATTERY MEASUREMENT AND AN EXTENDED CHARGE TIME THAT EXCEEDED SPECIFICATIONS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED, AND THE DEVICE REMAINS IMPLANTED AND IN SERVICE.

    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 67 YR 1488TC| T180| 0148