BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX REFLUX MANAGEMENT SYSTEM

    MDR report key: 7377751 · Received March 28, 2018

    Report

    Report Number
    3008766073-2018-00046
    Event Type
    Injury
    Date Received
    March 28, 2018
    Date of Event
    February 9, 2018
    Report Date
    February 27, 2018
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    UDI-DI
    00855106005332
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED ONGOING MODERATE 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 AND LINX DEVICE IMPLANTATION OCCURRED WITHOUT ISSUE ON (B)(6) 2016. ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH BALLOON DILATION TO 18 MM ON (B)(6) 2016. SHOWING "MODERATELY SEVERE STENOSIS" AT THE GEJ (GASTROESOPHAGEAL JUNCTION). EGD WITH BALLOON DILATION TO 20 MM ON (B)(6) 2016 SHOWING THE LINX IN GOOD POSITION. EGD WITH BALLOON DILATION TO 20 MM ON (B)(6) 2016 WITH LITTLE RESISTANCE, SHOWING THE LINX IN GOOD POSITION. EGD WITH BALLOON DILATION TO 20 MM ON (B)(6) 2017 SHOWING "MODERATELY SEVERE STENOSIS" AT THE GEJ, THE LINX IN GOOD POSITION, AND HILL GRADE 1. EGD AND DILATION WITH 60 FR BOUGIE ON (B)(6) 2017 SHOWING THE LINX IN GOOD POSITION AT THE GEJ, AND "MILD STENOSIS" AT THE GEJ. DEVICE EXPLANT DUE TO ONGOING MODERATE DYSPHAGIA OCCURRED WITHOUT ISSUE ON (B)(6) 2018. DEVICE WAS FOUND IN THE CORRECT POSITION/GEOMETRY. THE PATIENT'S SYMPTOMS "HAVE NOT SUBSTANTIALLY IMPROVED" AS OF (B)(6) 2018 AND THE PATIENT IS BEING MANAGED BY THEIR PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220581 LINX REFLUX MANAGEMENT SYSTEM ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LXMC13 10440 00855106005332

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| S