BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOLOGIX AFX

    MDR report key: 6282852 · Received January 25, 2017

    Report

    Report Number
    MW5067520
    Event Type
    Injury
    Date Received
    January 25, 2017
    Date of Event
    January 20, 2017
    Report Date
    January 20, 2017
    Manufacturer
    ENDOLOGIX
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAS AN ENDOLOGIX AFX DEVICE IMPLANTED. IT IS LEAKING AND APPEARS TO HAVE FABRIC TEARS AND STENT DISINTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60670 ENDOLOGIX AFX INTRODUCER, CATHETER DYB ENDOLOGIX

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening| R AMLODIPINE| ASA| ATENOLOL| ATORVASTATIN| MVC| ZYRTEC