BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINX

    MDR report key: 12057125 · Received June 24, 2021

    Report

    Report Number
    12057125
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    June 10, 2021
    Report Date
    June 15, 2021
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A LINX REFLUX MANAGEMENT SYSTEM PLACED EIGHT YEARS AGO. PATIENT REQUIRED SURGERY FOR THE REMOVAL OF THE LINX DEVICE BECAUSE IT ERODED THE ESOPHAGUS. TORAX MEDICAL, INC. WILL EVALUATE THE DEVICE ONCE RETURNED TO THEIR FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955281 LINX IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX LEI TORAX MEDICAL, INC. 3942

    Patients

    Seq Age Sex Outcome Treatment
    1 27740 DA Other