BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK ENDURANCE EZ

    MDR report key: 1041662 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34989
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 27, 2008
    Report Date
    March 31, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 Other THE DEVICE 4480/488758 WAS IMPLANTED 30-JAN-2008| THE DEVICE 4542/121158 WAS IMPLANTED 30-JAN-2008| THE DEVICE H197/312184 WAS IMPLANTED 30-JAN-2008