BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 1555786 · Received December 4, 2009

    Report

    Report Number
    2031527-2009-00170
    Event Type
    Injury
    Date Received
    December 4, 2009
    Date of Event
    October 30, 2009
    Report Date
    December 3, 2009
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE INFORMATION: MODEL NO. 28-28-75L, LOT NO. W09-2303-010, EXPIRATION DATE: 09/01/2012. REVIEW OF LOT RECORDS/WORK ORDERS, PRIOR REPORTS. NO ISSUES WERE NOTED. UNKNOWN IF PATIENT ANATOMY MET CRITERIA FOR INDICATIONS FOR USE. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IN 2009, PATIENT PRESENTED WITH ANGULATED NECK; HAD IMPLANT OF A 28-16-120BL BIFURCATED DEVICE AND TWO PROXIMAL EXTENSIONS. FOLLOW UP CT REVEALED A PROXIMAL TYPE I ENDOLEAK. LATER THAT MONTH, THE PATIENT WAS TREATED WITH A PALMAZ STENT. FINAL ANGIOGRAM STILL SHOWED AN ENDOLEAK, HOWEVER, IT WAS NOT DETERMINED IF IT IS A TYPE I OR II. THE PHYSICIAN WILL MONITOR THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERLINK SYSTEM INFRARENAL PROXIMAL EXTENSION MIH ENDOLOGIX, INC. 28-28-75L W09-1853-016

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention