BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2 DR

    MDR report key: 1043227 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33420
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 12, 2008
    Report Date
    March 11, 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 HEALTH CARE PROFESSIONAL

    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 73 YR Other THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 0184/116816 WAS IMPLANTED 10-OCT-2005| THE DEVICE 6481 040703 WAS USED DURING THE EVENT.| THE DEVICE 4244/440215 WAS IMPLANTED 10-OCT-2005