BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK

    MDR report key: 1042329 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34312
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 11, 2008
    Report Date
    March 17, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK IMPLANTABLE LEAD LWP CARDIAC PACEMAKERS, INC 4512 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention THE DEVICE 0155/354213 WAS IMPLANTED 20-SEP-2002| THE DEVICE 1823/105903 WAS IMPLANTED 20-SEP-2002| THE DEVICE 4053/412169 WAS IMPLANTED 20-SEP-2002| THE DEVICE 4470/553709 WAS IMPLANTED 02-NOV-2007| THE DEVICE 4470/553924 WAS IMPLANTED 02-NOV-2007| THE DEVICE 6482 028358 WAS USED DURING THE EVENT.| THE DEVICE 6483 507070 WAS USED DURING THE EVENT.| THE DEVICE 6487 507030 WAS USED DURING THE EVENT.| THE DEVICE H215/707959 WAS IMPLANTED 21-JUN-2007| THE DEVICE H215/708172 WAS IMPLANTED 02-NOV-2007