BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE EZ

    MDR report key: 1041999 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34654
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 19, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK ENDURANCE EZ IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0155 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention THE DEVICE 4087/116408 WAS IMPLANTED 10-OCT-2002| THE DEVICE 1861/238710 WAS IMPLANTED 10-OCT-2002