BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK C

    MDR report key: 1042480 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34155
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 6, 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 C IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0062 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other THE DEVICE 1857/705028 WAS IMPLANTED 06-MAR-2008| THE DEVICE 1857/702195 WAS IMPLANTED 14-NOV-2003| THE DEVICE 1746/603235 WAS IMPLANTED 31-MAR-1997| THE DEVICE 1600/754701 WAS IMPLANTED 16-JUL-1993