BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK C

    MDR report key: 1042412 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34227
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 4, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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 73 YR Required Intervention THE DEVICE H217/714834 WAS IMPLANTED 04-MAR-2008| THE DEVICE 4194/LFG040 WAS IMPLANTED 13-DEC-2005| THE DEVICE 4269/037564 WAS IMPLANTED 16-AUG-1993| THE DEVICE 0185/180512 WAS IMPLANTED 04-MAR-2008