BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX REFLUX MANAGEMENT SYSTEM

    MDR report key: 6091477 · Received November 9, 2016

    Report

    Report Number
    3008766073-2016-00087
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    October 6, 2016
    Report Date
    November 11, 2016
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED DEVICE ANALYSIS VERBIAGE: "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. NO CONCLUSION RELEVANT TO EXPERIENCE DETERMINED." DEVICE ANALYSIS METHOD CODES ADDED.

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED DYSPHAGIA AND REGURGITATION LEADING TO EXPLANT OF THE LINX DEVICE. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE WITH HERNIA REPAIR AND LINX DEVICE IMPLANTATION OCCURRED WITHOUT ISSUE IN (B)(6) 2011. UNEVENTFUL DEVICE EXPLANT DUE TO MILD DYSPHAGIA AND GERD SYMPTOMS ON (B)(6) 2016. LINX DEVICE FOUND IN CORRECT POSITION/GEOMETRY. DOR FUNDOPLICATION PERFORMED AT THE TIME OF EXPLANT.

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED DYSPHAGIA AND REGURGITATION LEADING TO EXPLANT OF THE LINX DEVICE. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. -ANTI-REFLUX PROCEDURE WITH HERNIA REPAIR AND LINX DEVICE IMPLANTATION OCCURRED WITHOUT ISSUE IN (B)(6) 2011. -UNEVENTFUL DEVICE EXPLANT DUE TO MILD DYSPHAGIA AND GERD SYMPTOMS ON (B)(6) 2016. -LINX DEVICE FOUND IN CORRECT POSITION/GEOMETRY. -DOR FUNDOPLICATION PERFORMED AT THE TIME OF EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742188 LINX REFLUX MANAGEMENT SYSTEM ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LX11 2231

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| S