BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY DR

    MDR report key: 1042802 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33833
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 19, 2008
    Report Date
    February 19, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC 1871 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other THE DEVICE 0148/157755 WAS IMPLANTED| THE DEVICE 4480/491172 WAS IMPLANTED