BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX REFLUX MANAGEMENT SYSTEM

    MDR report key: 5108449 · Received September 28, 2015

    Report

    Report Number
    3008766073-2015-00036
    Event Type
    Injury
    Date Received
    September 28, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 1, 2015
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    UDI-DI
    00855106005028
    PMA / PMN Number
    100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED DYSPHAGIA LEADING TO EXPLANT OF THE LINX DEVICE. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION OCCURRED WITHOUT ISSUE (B)(6) 2013 BY DR. (B)(6) AT (B)(6). UNEVENTFUL DEVICE EXPLANT DUE TO DYSPHAGIA ON (B)(6) 2015. DEVICE FOUND IN CORRECT POSITION/GEOMETRY. PATIENT IN SATISFACTORY CONDITION AFTER EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638587 LINX REFLUX MANAGEMENT SYSTEM ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LS13 7191 00855106005028

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| S