BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX REFLUX MANAGEMENT SYSTEM

    MDR report key: 4892490 · Received July 2, 2015

    Report

    Report Number
    3008766073-2015-00025
    Event Type
    Injury
    Date Received
    July 2, 2015
    Date of Event
    June 6, 2015
    Report Date
    June 6, 2015
    Manufacturer
    TORAX MEDICAL INC.
    Product Code
    LEI
    PMA / PMN Number
    100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATA RECEIVED 07/16/2015 BY MFR. 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 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) 2014. DYSPHAGIA FIRST REPORTED (B)(6) 2014 WITH SOME DELAY IN FOOD BOLUS PASSAGE NOTED VIA BARIUM ESOPHAGRAM. GASTROESOPHAGEAL BALLOON DILATION CONDUCTED (B)(6) 2015 DID NOT FULLY ALLEVIATE DYSPHAGIA SYMPTOMS. UNEVENTFUL DEVICE EXPLANT ON (B)(6) 2015. SMALL ANTERIOR HERNIATION INCLUDING DEVICE NOTED UPON EXPLANT. PT IS SATISFACTORY CONDITION AFTER EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431422 LINX REFLUX MANAGEMENT SYSTEM ANTI-REFLUX IMPLANT LEI TORAX MEDICAL INC. LX12 4164

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| S