BEUDAMED
    FDA Adverse Event Other Summary report: N

    POWERLINK SYSTEM

    MDR report key: 694032 · Received March 30, 2006

    Report

    Report Number
    2031527-2006-00006
    Event Type
    Other
    Date Received
    March 30, 2006
    Date of Event
    February 27, 2006
    Report Date
    March 20, 2006
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    APPROXIMATELY TWO WEEKS POST-IMPLANT, THE PATIENT DEVELOPED LEFT LIMB OCCLUSION, WITH ABSENT PULSE IN THE LEFT LEG.SHE UNDERWENT A LEFT ILISAC ARTERY PTA WITH PLACEMENT OT TWO STENTS, WITH RESTORATION OF PULSES IN HER LEG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM BIFURCATED INFRARENAL STENT GRAFT MIH ENDOLOGIX, INC. 28-16-140BL WO5-1066

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention