BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM HE DR

    MDR report key: 1042452 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34183
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    January 21, 2008
    Report Date
    March 7, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    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 64 YR Other THE DEVICE 4470/564539 WAS IMPLANTED 21-JAN-2008| THE DEVICE 4518/329560 WAS IMPLANTED 21-JAN-2008| THE DEVICE 4054/414064 WAS IMPLANTED 09-OCT-2000| THE DEVICE 0155/341484 WAS IMPLANTED 09-OCT-2000| THE DEVICE H219/205519 WAS IMPLANTED 21-JAN-2008