BEUDAMED
    FDA Adverse Event Other Summary report: N

    POWERLINK SYSTEM

    MDR report key: 700992 · Received April 18, 2006

    Report

    Report Number
    2031527-2006-00008
    Event Type
    Other
    Date Received
    April 18, 2006
    Date of Event
    September 9, 2005
    Report Date
    April 13, 2006
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICAIN REPORTED 30-DAY FOLLOW UP (FOR A PT IMPLANT ON 09/09/05) IN 2006, A PROXIMAL TYPE III ENDOLEAK WAS REPAIRED. ADDITIONAL INFORMATION RECEIVED 12 DAYS LATER INDICATES THIS REPAIR OCCURRED IN A SECONDARY ANGIOPLASTY IN 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL BIFURCATED STENT MIH ENDOLOGIX, INC. 28-16-140BL W05-0856

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention