BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK C

    MDR report key: 1002408 · Received February 7, 2008

    Report

    Report Number
    2124215-2008-31891
    Event Type
    Malfunction
    Date Received
    February 7, 2008
    Date of Event
    July 31, 2007
    Report Date
    July 31, 2007
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK C IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0115 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other THE DEVICE 4269/235808 WAS IMPLANTED 31-OCT-1995| THE DEVICE T135/931174 WAS IMPLANTED 02-DEC-2003| THE DEVICE 1720/253263 WAS IMPLANTED 31-OCT-1995| THE DEVICE 6481 029963 WAS USED DURING THE EVENT.