BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LD CV EZTRK 2 BP IS1 4543 90CM US

    MDR report key: 1042612 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34035
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 3, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWP
    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 LD CV EZTRK 2 BP IS1 4543 90CM US IMPLANTABLE LEAD LWP CARDIAC PACEMAKERS, INC 4543 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other THE DEVICE 0158/153914 WAS IMPLANTED 22-NOV-2006| THE DEVICE 4087/260498 WAS IMPLANTED 22-NOV-2006| THE DEVICE 6482 006449 WAS USED DURING THE EVENT.| THE DEVICE 6483 506010 WAS USED DURING THE EVENT.| THE DEVICE 6487 506020 WAS USED DURING THE EVENT.| THE DEVICE H210/206348 WAS IMPLANTED 22-NOV-2006| THE DEVICE LATR WAS USED DURING THE EVENT.