BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK DSP

    MDR report key: 1043536 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33113
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 2, 2008
    Report Date
    February 14, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z1144/1145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK DSP IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0125 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention THE DEVICE 1810/304197 WAS IMPLANTED 03-DEC-1997| THE DEVICE 6487 505100 WAS USED DURING THE EVENT.| THE DEVICE 6483 506020 WAS USED DURING THE EVENT.| THE DEVICE 6482 008283 WAS USED DURING THE EVENT.| THE DEVICE H215/703678 WAS IMPLANTED 19-SEP-2006| THE DEVICE 1823/107104 WAS IMPLANTED 24-SEP-2002| THE DEVICE 4269/283480 WAS IMPLANTED 03-DEC-1997| THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 4512/312401 WAS IMPLANTED 24-SEP-2002| THE DEVICE 0185/188944 WAS IMPLANTED 14-FEB-2008