BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX REFLUX MANAGEMENT SYSTEM

    MDR report key: 6012516 · Received October 7, 2016

    Report

    Report Number
    3008766073-2016-00068
    Event Type
    Injury
    Date Received
    October 7, 2016
    Date of Event
    September 8, 2016
    Report Date
    October 18, 2016
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    UDI-DI
    00855106005370
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT HAD THE LINX DEVICE EXPLANTED DUE TO INFECTION AT THE IMPLANT SITE. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. UNEVENTFUL ANTI-REFLUX PROCEDURE, HERNIA REPAIR, AND DEVICE IMPLANT ON (B)(6) 2016. PATIENT EXPERIENCED NAUSEA, DRY HEAVING, VOMITING AND FEVER AFTER DEVICE IMPLANT AND RECEIVED A CHEST X-RAY ON THE NIGHT OF (B)(6) 2016. REVIEW OF CHEST X-RAY BY IMPLANTING PHYSICIAN ON THE MORNING OF (B)(6) 2016 SHOWED THAT PATIENT HAD A HERNIA IN THE AREA OF THE LINX DEVICE. LAPAROSCOPIC SURGERY TO REPAIR HERNIA ON (B)(6) 2016 REVEALED A SIGNIFICANT AMOUNT OF WHITE-YELLOW FLUID AT IMPLANT SITE. BASED ON THE PRESENCE OF THE WHITE-YELLOW FLUID THE LINX DEVICE WAS EXPLANTED. THE IMPLANTING CENTER REPORTED THAT THE EXPLANTED LINX DEVICE COULD NOT BE CULTURED DUE TO CONTAMINATION AFTER REMOVAL FROM THE PATIENT. AFTER DEVICE REMOVAL A FUNDOPLICATION WAS PERFORMED.

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT HAD THE LINX DEVICE EXPLANTED DUE TO INFECTION AT THE IMPLANT SITE. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. UNEVENTFUL ANTI-REFLUX PROCEDURE, HERNIA REPAIR, AND DEVICE IMPLANT ON (B)(6) 2016. PATIENT EXPERIENCED NAUSEA, DRY HEAVING, VOMITING AND FEVER AFTER DEVICE IMPLANT AND RECEIVED A CHEST X-RAY ON THE NIGHT OF (B)(6) 2016. REVIEW OF CHEST X-RAY BY IMPLANTING PHYSICIAN ON THE MORNING OF (B)(6) 2016 SHOWED THAT PATIENT HAD A HERNIA IN THE AREA OF THE LINX DEVICE. LAPAROSCOPIC SURGERY TO REPAIR HERNIA ON (B)(6) 2016 REVEALED A SIGNIFICANT AMOUNT OF WHITE-YELLOW FLUID AT IMPLANT SITE. BASED ON THE PRESENCE OF THE WHITE-YELLOW FLUID THE LINX DEVICE WAS EXPLANTED. THE IMPLANTING CENTER REPORTED THAT THE EXPLANTED LINX DEVICE COULD NOT BE CULTURED DUE TO CONTAMINATION AFTER REMOVAL FROM THE PATIENT. AFTER DEVICE REMOVAL A FUNDOPLICATION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662711 LINX REFLUX MANAGEMENT SYSTEM ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LXMC17 10717 00855106005370

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| O