BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX REFLUX MANAGEMENT SYSTEM

    MDR report key: 3504109 · Received November 26, 2013

    Report

    Report Number
    3008766073-2013-00030
    Event Type
    Injury
    Date Received
    November 26, 2013
    Date of Event
    October 29, 2013
    Report Date
    November 2, 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 PATIENT EXPERIENCED A RETURN OF GERD SYMPTOMS (HEARTBURN AND RECURRENT COUGH). THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION OCCURRED ON (B)(6) 2012. UNEVENTFUL DEVICE EXPLANT ON (B)(6) 2013. IMPLANT OF A NEW LINX REFLUX MANAGEMENT SYSTEM, MODEL LX13 OCCURRED ON (B)(6) 2013 AT TIME OF ORIGINAL DEVICE EXPLANT. PHYSICIAN WAS NOTIFIED PREVIOUS TO PROCEDURE BY TORAX MEDICAL THAT THIS IS CONTRAINDICATED. PATIENT CONDITION IS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615093 LINX REFLUX MANAGEMENT SYSTEM LEI TORAX MEDICAL INC. LX14 3272

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| S