BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX REFLUX MANAGEMENT SYSTEM

    MDR report key: 6818286 · Received August 24, 2017

    Report

    Report Number
    3008766073-2017-00094
    Event Type
    Injury
    Date Received
    August 24, 2017
    Date of Event
    July 27, 2017
    Report Date
    July 28, 2017
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    UDI-DI
    00855106005349
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED ONGOING GERD LEADING TO LINX DEVICE EXPLANT. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. UNEVENTFUL ANTI-REFLUX PROCEDURE INCLUDING A COMPLETE TAKEDOWN OF THE HIATUS AND LINX DEVICE IMPLANT ON (B)(6) 2015 BY DR. (B)(6). DEVICE WAS IMPLANTED ABOVE THE GASTROESOPHAGEAL JUNCTION (GEJ) AT A SITE THAT "CLEARLY LOOKED LIKE THE GEJ BUT THE PRIOR TIF PROCEDURE DISTORTS THE ANATOMY MAKING IT VERY DECEIVING." PATIENT REMAINED ON PPIS FOR ABOUT 4 MONTHS AFTER DEVICE IMPLANT. PATIENT STARTED TO DEVELOP REGURGITATION, HEARTBURN, AND SOME DYSPHAGIA. UNEVENTFUL DEVICE EXPLANT ON (B)(6) 2017 DUE TO ONGOING GERD SYMPTOMS BY DR. (B)(6) AT (B)(6). DEVICE HAD A DENSE ENCAPSULATION AROUND IT AT THE TIME OF REMOVAL AND WAS NOTED AS 3CM ABOVE THE ENDOSCOPICALLY IDENTIFIED GEJ (SAME AS IMPLANT SITE) WHICH WAS DIFFICULT TO ACCESS GIVEN THE PREVIOUS TIF PROCEDURE. AFTER DEVICE REMOVAL, A HERNIA REPAIR WAS PERFORMED AND A SECOND LINX DEVICE (MODEL: LXMC16, LOT # 8577, SERIAL # (B)(4)) WAS IMPLANTED AT THE GEJ WITHOUT ISSUE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596193 LINX REFLUX MANAGEMENT SYSTEM ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LXMC14 9101 00855106005349

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| O