BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX REFLUX MANAGEMENT SYSTEM

    MDR report key: 5600485 · Received April 22, 2016

    Report

    Report Number
    3008766073-2016-00029
    Event Type
    Injury
    Date Received
    April 22, 2016
    Date of Event
    March 23, 2016
    Report Date
    April 28, 2016
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    UDI-DI
    00855106005011
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. PATIENT REPORTED PAIN AND CHEST PRESSURE FOR THE FIRST WEEK AFTER DEVICE EXPLANT BUT HAS BEEN ABLE TO EAT REGULARLY AFTER THAT. DEVICE LOT NUMBER OBTAINED FROM IMPLANTING CENTER.

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED DYSPHAGIA AND DECLINING ESOPHAGEAL MOTILITY 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) 2012 BY DR. (B)(6). GASTROESOPHAGEAL BALLOON DILATION WAS PERFORMED ON THREE DIFFERENT OCCASIONS AND DID NOT FULLY ALLEVIATE DYSPHAGIA SYMPTOMS. UNEVENTFUL DEVICE EXPLANT DUE TO DYSPHAGIA ON (B)(6) 2016 BY DR. (B)(6). DEVICE FOUND IN CORRECT POSITION/GEOMETRY.

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED DYSPHAGIA AND DECLINING ESOPHAGEAL MOTILITY 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) 2012 BY DR. (B)(6). GASTROESOPHAGEAL BALLOON DILATION WAS PERFORMED ON THREE DIFFERENT OCCASIONS AND DID NOT FULLY ALLEVIATE DYSPHAGIA SYMPTOMS. UNEVENTFUL DEVICE EXPLANT DUE TO DYSPHAGIA ON (B)(6) 2016 BY DR. (B)(6) AT (B)(6). DEVICE FOUND IN CORRECT POSITION/GEOMETRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256019 LINX REFLUX MANAGEMENT SYSTEM ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LS12 3457 00855106005011

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization| S