BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX REFLUX MANAGEMENT SYSTEM

    MDR report key: 4860185 · Received June 19, 2015

    Report

    Report Number
    3008766073-2015-00021
    Event Type
    Injury
    Date Received
    June 19, 2015
    Date of Event
    May 19, 2015
    Report Date
    May 19, 2015
    Manufacturer
    TORAX MEDICAL INC.
    Product Code
    LEI
    UDI-DI
    00855106005028
    PMA / PMN Number
    100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATA RECEIVED ON 06/16/2015 BY MFR. REASON FOR EXPLANT: DYSPHAGIA. PT BMI: (B)(6). MANOMETRY AND PH TESTING COMPLETED PREVIOUS TO ANTI-REFLUX PROCEDURE. PT'S MOTILITY APPEARS TO HAVE DECREASED SINCE TIME OF ANTI-REFLUX PROCEDURE. DEVICE FOUND IN CORRECT POSITION/GEOMETRY AT TIME OF EXPLANT. DEVICE ANALYSIS CONDUCTED BY TORAX MEDICAL ENGINEERING AFTER PRODUCT RECEIPT. GROSS ANALYSIS REVEALED NO DEVICE ANOMALIES ATYPICAL FROM AN EXPLANTED DEVICE. MICROSCOPIC ANALYSIS REVEALED ALL DEVICE COMPONENTS AND ASSEMBLY EXHIBITED NORMAL CHARACTERISTICS OF AN EXPLANTED DEVICE. FORCE TESTING, LENGTH TESTING, AND GEOMETRIC ANALYSIS EXHIBITED NO ANOMALIES. NO CONCLUSION RELEVANT TO EXPERIENCE DETERMINED.

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PT HAD THE LINX DEVICE EXPLANTED. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. LINX EXPLANT WENT WELL WITH NO ISSUES. NO FURTHER INFO HAS BEEN PROVIDED BY PHYSICIAN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401204 LINX REFLUX MANAGEMENT SYSTEM LEI TORAX MEDICAL INC. LS13 4097 00855106005028

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| S