BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX REFLUX MANAGEMENT SYSTEM

    MDR report key: 4939617 · Received July 22, 2015

    Report

    Report Number
    3008766073-2015-00028
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    July 6, 2015
    Report Date
    August 17, 2015
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE TRACEABILITY INFORMATION: LOT NUMBER 4966. SERIAL NUMBER (B)(4). PATIENT IS REPORTED AS OK WITH SOME LINGERING PAIN AFTER EXPLANT. PRODUCT NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED DYSPHAGIA LEADING TO EXPLANT OF THE LINX DEVICE. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION OCCURRED WITHOUT ISSUE (B)(6) 2013. UNEVENTFUL DEVICE EXPLANT ON (B)(6) 2015. DEVICE FOUND IN CORRECT LOCATION/GEOMETRY. PATIENT IN SATISFACTORY CONDITION AFTER EXPLANT.

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED DYSPHAGIA LEADING TO EXPLANT OF THE LINX DEVICE. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION OCCURRED WITHOUT ISSUE (B)(6) 2013. UNEVENTFUL DEVICE EXPLANT ON (B)(6) 2015. DEVICE FOUND IN CORRECT LOCATION/GEOMETRY. PATIENT IN SATISFACTORY CONDITION AFTER EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475548 LINX REFLUX MANAGEMENT SYSTEM ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LXC13 4966

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| S