BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX REFLUX MANAGEMENT SYSTEM

    MDR report key: 2974110 · Received February 13, 2013

    Report

    Report Number
    3008766073-2013-00004
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    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, A PT EXPERIENCED UN-EXPLANTED ABDOMINAL PAIN. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION OCCURRED ON (B)(6) 2012. PAIN OCCURRED 3-4 TIMES A WEEK AFTER A MEAL AND ORIGINATED IN THE ESOPHAGUS AREA AND EMANATED OUTWARD FROM THAT POINT. ALL DIAGNOSTICS FOR CAUSE OF PAIN INCLUDING BARIUM SWALLOW ARE NORMAL. UNEVENTFUL DEVICE EXPLANT ON (B)(6) 2013. DEVICE FOUND IN CORRECT POSITION AND GEOMETRY. PT ELECTED TO UNDERGO TOUPET FUNDOPLICATION AT TIME OF DEVICE EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64248 LINX REFLUX MANAGEMENT SYSTEM LEI TORAX MEDICAL INC. LX12 2451

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S POSTERIOR HIATAL/CRURAL REPAIR