BEUDAMED
    FDA Adverse Event Other Summary report: N

    POWERLINK SYSTEM

    MDR report key: 808015 · Received January 19, 2007

    Report

    Report Number
    2031527-2006-00049
    Event Type
    Other
    Date Received
    January 19, 2007
    Report Date
    January 19, 2007
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED ON 30-DAY FOLLOW UP FORM (DATED 01/08/07) FOR A PT IMPLANT IN 2006; PATIENT REQUIRED BOWEL RESECTION TWO DAYS LATER. PHYSICIAN INDICATED ON FORM THAT EVENT WAS RELATED TO IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM DUAL LUMEN CATHETER MIH ENDOLOGIX, INC. DL-35-90 W06-0999

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention