BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK ENDURANCE RX

    MDR report key: 1042969 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33666
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    January 30, 2008
    Report Date
    January 30, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK ENDURANCE RX IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0145 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other THE DEVICE 1850/202661 WAS IMPLANTED 04-MAR-2004| THE DEVICE 0184/132509 WAS IMPLANTED 30-JAN-2008| THE DEVICE T135/949382 WAS IMPLANTED 30-JAN-2008