BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX REFLUX MANAGEMENT SYSTEM

    MDR report key: 6030170 · Received October 14, 2016

    Report

    Report Number
    3008766073-2016-00071
    Event Type
    Injury
    Date Received
    October 14, 2016
    Date of Event
    September 7, 2016
    Report Date
    October 25, 2016
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    UDI-DI
    00855106005028
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED ONGOING GERD WITH ASSOCIATED GAS AND NAUSEA LEADING TO LINX DEVICE EXPLANT. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. PATIENT EXPERIENCED DYSPHAGIA BEFORE DEVICE IMPLANT THAT REQUIRED DILATIONS ON AT LEAST 2 OCCASIONS. UNEVENTFUL ANTI-REFLUX PROCEDURE AND DEVICE IMPLANT ON (B)(6) 2012. UNEVENTFUL DEVICE EXPLANT (B)(6) 2016. IMMEDIATELY AFTER DEVICE EXPLANT THE PATIENT HAD A REPLACEMENT LINX DEVICE IMPLANTED. PATIENT IS REPORTEDLY "DOING GREAT!" AFTER IMPLANTATION OF A REPLACEMENT LINX DEVICE. PATIENT REPORTS THAT NAUSEA, ACID REFLUX AND HEARTBURN HAVE BEEN RESOLVED.

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED ONGOING GERD WITH ASSOCIATED GAS AND NAUSEA LEADING TO LINX DEVICE EXPLANT. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. PATIENT EXPERIENCED DYSPHAGIA BEFORE DEVICE IMPLANT THAT REQUIRED DILATIONS ON AT LEAST 2 OCCASIONS; UNEVENTFUL ANTI-REFLUX PROCEDURE AND DEVICE IMPLANT ON (B)(6) 2012; UNEVENTFUL DEVICE EXPLANT (B)(6) 2016; IMMEDIATELY AFTER DEVICE EXPLANT THE PATIENT HAD A REPLACEMENT LINX DEVICE IMPLANTED; PATIENT IS REPORTEDLY "DOING GREAT!" AFTER IMPLANTATION OF A REPLACEMENT LINX DEVICE. PATIENT REPORTS THAT NAUSEA, ACID REFLUX AND HEARTBURN HAVE BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681294 LINX REFLUX MANAGEMENT SYSTEM ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LS13 3441 00855106005028

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| O