BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1853554 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14851
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 19, 2010
    Report Date
    October 18, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-0047-2008 TO Z-0053-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THAT THE DEVICE REMAINS IN-SERVICE. THE EVENT WILL BE REOPENED IF ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE IS RETURNED FOR LABORATORY TESTING.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE DEVICE WAS SUCCESSFULLY INTERROGATED BY BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY. ENGINEERING CALCULATIONS DETERMINED THAT THIS DEVICE DID MEET EXPECTED LONGEVITY. THE DEVICE WAS PUT THROUGH AND PASSED THERAPY AVAILABILITY TESTING. IT WAS CONCLUDED THAT THE DEVICE PERFORMED NORMALLY THROUGHOUT LABORATORY TESTING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE TRIGGERED ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE'S MONITORING VOLTAGE WAS 2.54 VOLTS AND WAS ASSOCIATED WITH A CHARGE TIME OF 24.8 SECONDS. TECHNICAL SERVICES EXPLAINED THAT ERI WAS TRIGGERED DUE TO CHARGE TIME AND DISCUSSED THE MID-LIFE DISPLAY OF REPLACEMENT INDICATOR ADVISORY. TECHNICAL SERVICES RECOMMENDED THAT THE DEVICE SHOULD BE REPLACED WITHIN 90 DAYS OF ERI DECLARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T125

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR T125| 4473| 0186