BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY DS

    MDR report key: 1253917 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40807
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 23, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z47/53-08
    Adverse Event
    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 DS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T125 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention THE DEVICE 4480/426550 WAS IMPLANTED 25-JAN-2005| THE DEVICE 0158/147778 WAS IMPLANTED 25-JAN-2005| THE DEVICE 6481 021954 WAS USED DURING THE EVENT.| THE DEVICE T165/144347 WAS IMPLANTED 26-SEP-2008| THE DEVICE 0158/179984 WAS IMPLANTED 26-SEP-2008