BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1874919 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-18007
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    August 9, 2010
    Report Date
    September 9, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1047-2007 TO Z-1055-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REPLACEMENT WAS RECOMMENDED. AS OF TODAY ALL AVAILABLE INFORMATION INDICATES THAT THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE EXHIBITED LONG CHARGE TIMES DURING MIDDLE OF LIFE RESULTING IN EARLY DISPLAY OF END OF LIFE INDICATORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR MISMATCH| 1790| 0015| 0095| T177