BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1040045 · Received May 7, 2008

    Report

    Report Number
    2031527-2008-00022
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    March 19, 2008
    Report Date
    May 7, 2008
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. OPERATIONAL CONTEXT CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    PT HAD SUCCESSFUL IMPLANT OF A BIFURCATED DEVICE AND A PROXIMAL CUFF IN LATE 07. A FOLLOW UP VISIT DETECTED A DISTAL TYPE I ENDOLEAK. IN 2008, THE PT WAS BROUGHT IN TO TREAT THE ENDOLEAK WITH TWO LIMB EXTENSIONS. PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 25-16-140BL W07-1257

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention