BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX REFLUS MANAGEMENT SYSTEM

    MDR report key: 3833438 · Received May 21, 2014

    Report

    Report Number
    3008766073-2014-00009
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 23, 2014
    Manufacturer
    TORAX MEDICAL INC.
    Product Code
    LEI
    PMA / PMN Number
    100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE UTILIZING THE LINX DEVICE, A PT EXPERIENCED DYSPHAGIA LEADING TO DEVICE EXPLANT. ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION OCCURRED ON (B)(6) 2013 AT ARABELLA KLINIK IN MUNICH, GERMANY.; DYSPHAGIA REPORTED TO BEGIN IMMEDIATELY POST ANTI-REFLUX PROCEDURE.; GASTROSCOPY AND GASTROESOPHAGEAL BALLOON DILATION OCCURRED (B)(6) 2013 BUT DID NOT ALLEVIATE SYMPTOMS.; UNEVENTFUL DEVICE EXPLANT ON (B)(6) 2014. DEVICE FOUND IN CORRECT POSITION AND GEOMETRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302100 LINX REFLUS MANAGEMENT SYSTEM LEI TORAX MEDICAL INC. LX13 3707

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| S HIATAL HERNIA REPAIR COMPLETED AT TIME OF IMPLANT