BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE EZ

    MDR report key: 1043490 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33151
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 5, 2008
    Report Date
    February 5, 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 ENDOTAK ENDURANCE EZ IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0154 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention THE DEVICE 4555/160580 WAS IMPLANTED 05-NOV-2007| THE DEVICE 04 / WAS IMPLANTED| THE DEVICE 6482 022739 WAS USED DURING THE EVENT.| THE DEVICE 4086/101612 WAS IMPLANTED 15-APR-2002| THE DEVICE H210/214235 WAS IMPLANTED 05-NOV-2007