BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2 VR

    MDR report key: 1253936 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40534
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 15, 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 VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T175 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other THE DEVICE 1850/107370 WAS IMPLANTED 26-JAN-2001| THE DEVICE 0145/338787 WAS IMPLANTED 26-JAN-2001| THE DEVICE 6481 311069 WAS USED DURING THE EVENT.