BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX REFLUX MANAGEMENT SYSTEM

    MDR report key: 5095005 · Received September 22, 2015

    Report

    Report Number
    3008766073-2015-00034
    Event Type
    Injury
    Date Received
    September 22, 2015
    Date of Event
    July 7, 2015
    Report Date
    December 17, 2015
    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

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING NARRATIVE 12/17/2015: -DATE OF BIRTH: (B)(6) 1964, MALE,. -DATE OF ANTI-REFLUX PROCEDURE INCLUDING IMPLANT WAS (B)(6) 2015. MANOMETRY AND PH TESTING WERE COMPLETED PREVIOUS TO IMPLANT. -DATE OF EXPLANT WAS (B)(6) 2015 DUE TO DYSPHAGIA AND PSYCHOLOGICAL DISORDER. -EXPLANTED DEVICE WAS REPORTED AS MODEL LX15, LOT NUMBER 6745, SERIAL NUMBER (B)(4). -DEVICE WAS FOUND IN CORRECT POSITION/GEOMETRY. -DEVICE WILL NOT BE RETURNED TO TORAX MEDICAL FOR ANALYSIS.

    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. -NO ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM CLINICAL SITE AT THIS TIME.-PATIENT IS REPORTED AS WELL AFTER DEVICE EXPLANT.

    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. -NO ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM CLINICAL SITE AT THIS TIME. -PATIENT IS REPORTED AS WELL AFTER DEVICE EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626579 LINX REFLUX MANAGEMENT SYSTEM ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LX15 6745

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| S