BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM HE DR

    MDR report key: 1042476 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34178
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 6, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM HE DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC 1858 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other THE DEVICE 1705/666050 WAS IMPLANTED 14-OCT-1994| THE DEVICE 6836/008540 WAS IMPLANTED 14-OCT-1994| THE DEVICE 0074/003208 WAS IMPLANTED 14-OCT-1994| THE DEVICE 1826/401411 WAS IMPLANTED 10-DEC-1998| THE DEVICE 0015/200886 WAS IMPLANTED 10-DEC-1998| THE DEVICE 6481 041997 WAS USED DURING THE EVENT.| THE DEVICE 0063/004796 WAS IMPLANTED 14-OCT-1994| THE DEVICE 1858/800318 WAS IMPLANTED 27-MAR-2003