BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1530621 · Received November 11, 2009

    Report

    Report Number
    2031527-2009-00151
    Event Type
    Injury
    Date Received
    November 11, 2009
    Date of Event
    October 14, 2009
    Report Date
    November 10, 2009
    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

    ADDITIONAL DEVICE INFO: MODEL NO. 34-34-100RL; LOT NO. W09-0822-016. EXP DATE: 04/01/12. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. UNK IF PT ANATOMY MET CRITERIA FOR INDICATIONS FOR USE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IN 2007, PT HAD IMPLANT OF A 28-16-140BL BIFURCATED DEVICE. IN 2009, THE PT WAS TREATED FOR A PROXIMAL TYPE I ENDOLEAK WITH A 34-34-100RL SUPRARENAL PROXIMAL EXTENSION. AT APPROX 4 MONTHS LATER, THE PT WAS TREATED FOR A TYPE III ENDOLEAK BETWEEN THE MAIN BODY AND THE SUPRARENAL CUFF WITH A PALMAZ STENT. THE PROCEDURE WAS COMPLETED WITH GOOD RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 28-16-140BL W06-1403-017

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR