BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK BIFURCATED SYSTEM

    MDR report key: 663463 · Received January 12, 2006

    Report

    Report Number
    2031527-2005-00035
    Event Type
    Injury
    Date Received
    January 12, 2006
    Date of Event
    December 19, 2005
    Report Date
    December 21, 2005
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IMPLANT 2005, 30-DAY REPORT STATED: TYPE III ENDOLEAK BY CT. SCAN SCHEDULED FOR ARTERIOGRAM JANUARY 2006 AND FURTHER MANAGEMENT TO FOLLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK BIFURCATED SYSTEM INFRARENAL BIFURCATED STENT MIH ENDOLOGIX, INC. 26-16 140BL W05-0522

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other