BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX REFLUX MGMT SYS

    MDR report key: 3802821 · Received May 7, 2014

    Report

    Report Number
    3008766073-2014-00008
    Event Type
    Injury
    Date Received
    May 7, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    TORAX MEDICAL INC.
    Product Code
    LEI
    PMA / PMN Number
    100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE UTILIZING THE LINX DEVICE, A PT EXPERIENCED DYSPHAGIA LEADING TO LINX DEVICE EXPLANT. ANTI-REFLUX PROCEDURE. UNEVENTFUL DEVICE EXPLANT ON (B)(6) 2014. POST-REMOVAL ENDOSCOPY ASSESSMENT SHOWED NORMAL FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273581 LINX REFLUX MGMT SYS LEI TORAX MEDICAL INC. LS12 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S