BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM HE DR

    MDR report key: 1042339 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34294
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 11, 2008
    Report Date
    March 11, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    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 VENTAK PRIZM HE DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC 1853 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other THE DEVICE 4312/045132 WAS IMPLANTED 14-FEB-1991| THE DEVICE 6481 053562 WAS USED DURING THE EVENT.| THE DEVICE 0041/134708 WAS IMPLANTED 14-FEB-1991| THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 0154/341777 WAS IMPLANTED 28-SEP-2000| THE DEVICE 0056/008028 WAS IMPLANTED 01-DEC-1995| THE DEVICE 4312/045133 WAS IMPLANTED 14-FEB-1991| THE DEVICE 0040/110399 WAS IMPLANTED 14-FEB-1991