BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX REFLUX MANAGEMENT SYSTEM

    MDR report key: 6073486 · Received November 2, 2016

    Report

    Report Number
    3008766073-2016-00079
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    October 5, 2016
    Report Date
    October 5, 2016
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    UDI-DI
    00855106005165
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED DYSPHAGIA LEADING TO LINX DEVICE EXPLANT. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. UNEVENTFUL ANTI-REFLUX PROCEDURE AND DEVICE IMPLANT ON (B)(4) 2016. ESOPHAGEAL ENDOSCOPY WITH DILATION (THEE DIFFERENT ATTEMPTS) AND STEROIDS WERE PRESCRIBED TO ALLEVIATE POST ANTI-REFLUX PROCEDURE DYSPHAGIA. DEVICE EXPLANT (B)(6) 2016 DUE TO DYSPHAGIA. DEVICE FOUND IN CORRECT POSITION/GEOMETRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723344 LINX REFLUX MANAGEMENT SYSTEM ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LXC15 4882 00855106005165

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| S