BEUDAMED
    FDA Adverse Event Other Summary report: N

    POWERLINK SYSTEM

    MDR report key: 728982 · Received June 27, 2006

    Report

    Report Number
    2031527-2006-00018
    Event Type
    Other
    Date Received
    June 27, 2006
    Date of Event
    May 24, 2006
    Report Date
    June 27, 2006
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H6. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED ON 30-DAY F/U FORM (DATED 6/15/06) THAT A PT UNDERWENT DIALYSIS FOR RENAL EMBOLI IN 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 28-16-140BL WO6-0133

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention