BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX REFLUX MANAGEMENT SYSTEM

    MDR report key: 5295843 · Received December 14, 2015

    Report

    Report Number
    3008766073-2015-00056
    Event Type
    Injury
    Date Received
    December 14, 2015
    Date of Event
    November 13, 2015
    Report Date
    February 26, 2016
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER NARRATIVE BASED ON DATA OBTAINED 02/26/2016: 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 PATIENT EXPERIENCED ONGOING GERD LEADING TO LINX DEVICE EXPLANT. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE AND DEVICE IMPLANT DATE NOT REPORTED. UNEVENTFUL DEVICE EXPLANT (B)(6) 2015. AFTER DEVICE REMOVAL, PATIENT UNDERWENT A FUNDOPLICATION.

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED ONGOING GERD LEADING TO LINX DEVICE EXPLANT. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE AND DEVICE IMPLANT DATE NOT REPORTED. UNEVENTFUL DEVICE EXPLANT (B)(6) 2015. AFTER DEVICE REMOVAL, PATIENT UNDERWENT A FUNDOPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824920 LINX REFLUX MANAGEMENT SYSTEM ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S