BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2 DR

    MDR report key: 1043045 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33602
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 18, 2008
    Report Date
    February 18, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z47/55-07
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T165 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other THE DEVICE 0185/132756 WAS IMPLANTED 30-MAR-2006| THE DEVICE 0185/138754 WAS IMPLANTED 30-MAR-2006| THE DEVICE 4087/250948 WAS IMPLANTED 30-MAR-2006| THE DEVICE 6481 001425 WAS USED DURING THE EVENT.