BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX REFLUX MANAGEMENT SYSTEM

    MDR report key: 4939618 · Received July 22, 2015

    Report

    Report Number
    3008766073-2015-00029
    Event Type
    Injury
    Date Received
    July 22, 2015
    Date of Event
    June 24, 2015
    Report Date
    June 24, 2015
    Manufacturer
    TORAX MEDICAL INC.
    Product Code
    LEI
    PMA / PMN Number
    100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PT EXPERIENCED DRY-HEAVING AND A DISTENDED BELLY. UPON FURTHER DIAGNOSIS WAS DETERMINED AN ESOPHAGEAL PERFORATION EXISTED. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION OCCURRED ON (B)(6) 2015 WITH NO NOTED COMPLICATIONS. PT EXPERIENCED DRY-HEAVING FOR MULTIPLE DAYS AND DISTENDED BELLY LEADING TO DIAGNOSIS OF ESOPHAGEAL PERFORATION. PERFORATION WAS DESCRIBED AS A SMALL POSTERIOR ESOPHAGEAL HOLE. DEVICE EXPLANTED ON (B)(6) 2015 BY DR.(B)(6) OF THE (B)(6) WITH NO NOTABLE OBSERVATIONS ABOUT LINX DEVICE. LINX DEVICE FOUND IN CORRECT POSITION/GEOMETRY. IT WAS NOT DETERMINED THE CAUSE OF THE PERFORATION (E. G., SURGICAL DAMAGE, DAMAGE DUE TO DRY-HEAVING, ETC.). PT IS SATISFACTORY CONDITION AFTER EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475685 LINX REFLUX MANAGEMENT SYSTEM ANTI-REFLUX IMPLANT LEI TORAX MEDICAL INC. LXMC17 8179

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| O