BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX REFLUX MANAGEMENT SYSTEM

    MDR report key: 10975607 · Received December 8, 2020

    Report

    Report Number
    MW5098256
    Event Type
    Injury
    Date Received
    December 8, 2020
    Date of Event
    October 12, 2020
    Report Date
    December 4, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    QJN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SURGERY FOR GERD AND HIATAL HERNIA TOOK PLACE AT (B)(6) ON (B)(6) 2020 INSERTING LINX DEVICE. PT DC'D (B)(6) 2020. PT READMITTED WITH SERIOUS INTERNAL BLEEDING ON (B)(6) 2020. AFTER 2 BLOOD TRANSFUSIONS PT DC'D ON (B)(6). PT STRUGGLED W/ DYSPHASIA, NAUSEA AND VOMITING. PT READMITTED TO HOSPITAL ON (B)(6) 2020 AFTER VOMITING BLOOD - GI BLEEDING. EGD PROCEDURE SHOWED THAT 2 BEADS FROM THE LINX DEVICE HAS ERODED INTO ESOPHAGUS. EGD PROCEDURE SHOWED THAT AT LEAST 2 BEADS FROM THE LINX DEVICE HAD ERODED INTO THE LUMEN AT GE JUNCTION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429090 LINX REFLUX MANAGEMENT SYSTEM LAPAROSCOPIC ACCESSORIES, ESOPHAGEAL SIZING QJN ETHICON ENDO-SURGERY, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R| S