BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX REFLUX MANAGEMENT SYSTEM

    MDR report key: 6880297 · Received September 20, 2017

    Report

    Report Number
    3008766073-2017-00109
    Event Type
    Injury
    Date Received
    September 20, 2017
    Date of Event
    August 4, 2017
    Report Date
    August 24, 2017
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    UDI-DI
    00855106005349
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 INCLUDING HERNIA REPAIR, LINX DEVICE IMPLANTATION, AND USE OF MESH OCCURRED WITHOUT ISSUE ON (B)(6) 2016. PRIOR TO DEVICE REMOVAL, THE PATIENT HAD TWO ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH DILATIONS AND A CT SCAN SUGGESTED A HERNIA RECURRED AND THE GEJ AND FIXED LINX DEVICE SHIFTED INTO THE MEDIASTINUM. DEVICE EXPLANT DUE TO DYSPHAGIA OCCURRED WITHOUT ISSUE ON (B)(6) 2017; A FUNDOPLICATION WAS PERFORMED AT THE TIME OF EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659067 LINX REFLUX MANAGEMENT SYSTEM ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LXMC14 11173 00855106005349

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| S