BEUDAMED
    FDA Adverse Event Other Summary report: N

    POWERLINK SYSTEM

    MDR report key: 712783 · Received May 11, 2006

    Report

    Report Number
    2031527-2006-00012
    Event Type
    Other
    Date Received
    May 11, 2006
    Date of Event
    April 19, 2006
    Report Date
    May 11, 2006
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT IMPLANTED WITH BIFURCATED AND CUFF DEVICES IN 06. PHYSICIAN INDICATED ON 30-DAY FOLLOW UP FORM THAT PATIENT HAD A TYPE I ENDOLEAK 3 MONTHS POST IMPLANT (4/19/06). A SECONDARY PROCEDURE WAS DONE TO IMPLANT AN ADDITIONAL CUFF AND PALMAZ STENT TO SUCCESSFULLY RESOLVE THE ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM BIFURCATED INFRARENAL STENT GRAFT MIH ENDOLOGIX, INC. 28-16-155BL W05-0966

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention