BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX REFLUX MANAGEMENT SYSTEM

    MDR report key: 6209712 · Received December 28, 2016

    Report

    Report Number
    3008766073-2016-00112
    Event Type
    Injury
    Date Received
    December 28, 2016
    Date of Event
    November 28, 2016
    Report Date
    February 22, 2017
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    UDI-DI
    00855106005011
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE A PATIENT EXPERIENCED GRADUAL DEVELOPING DYSPHAGIA SYMPTOMS LEADING TO ENDOSCOPIC VISUALIZATION OF SEVEN LINX DEVICE BEADS WITHIN THE ESOPHAGEAL LUMEN ON (B)(6) 2016 AND SUBSEQUENT DEVICE EXPLANT. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION OCCURRED WITHOUT ISSUE ON (B)(6) 2013. X-RAY EXAMINATION DUE TO DYSPHAGIA SYMPTOMS ON (B)(6) 2016 SHOWED THE LINX DEVICE IN AN "ODD POSITION" AND AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED ALSO ON (B)(6) 2016 CONFIRMED AT LEAST SEVEN LINX DEVICE BEADS IN THE ESOPHAGEAL LUMEN. PATIENT WAS REPORTED AS ABLE TO SWALLOW SOFT FOODS AND LIQUIDS AT TIME OF EROSION DISCOVERY. UNEVENTFUL ENDOSCOPIC EXPLANT OF 6 LINX DEVICE BEADS ON (B)(6) 2016. PATIENT IS DOING WELL AND ONLY COMPLAINED OF A SORE THROAT AFTER SURGERY. UNEVENTFUL HERNIA REPAIR AND LAPAROSCOPIC EXPLANT OF REMAINING 6 LINX DEVICE BEADS ON (B)(6) 2017. PATIENT DOING WELL ON (B)(6) 2017; PRESCRIBED PROTONIX AND ZANTAC TO MANAGE REFLUX.

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE A PATIENT EXPERIENCED GRADUAL DEVELOPING DYSPHAGIA SYMPTOMS LEADING TO ENDOSCOPIC VISUALIZATION OF SEVEN LINX DEVICE BEADS WITHIN THE ESOPHAGEAL LUMEN ON (B)(6) 2016. THE LINX DEVICE WAS USED AS PART OF THE ANTI-REFLUX PROCEDURE. -ANTI-REFLUX PROCEDURE AND LINX DEVICE IMPLANTATION OCCURRED WITHOUT ISSUE ON (B)(6) 2013. -X-RAY EXAMINATION DUE TO DYSPHAGIA SYMPTOMS ON (B)(6) 2016 SHOWED THE LINX DEVICE IN AN "ODD POSITION" AND AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED ALSO ON (B)(6) 2016 CONFIRMED AT LEAST SEVEN LINX DEVICE BEADS IN THE ESOPHAGEAL LUMEN. -PATIENT WAS REPORTED AS ABLE TO SWALLOW SOFT FOODS AND LIQUIDS AT TIME OF EROSION DISCOVERY. -UNEVENTFUL ENDOSCOPIC EXPLANT OF 6 LINX DEVICE BEADS ON (B)(6) 2016. THE PHYSICIAN PLANS TO LAPAROSCOPICALLY REMOVE THE REMAINDER OF THE DEVICE AT A LATER DATE. -PATIENT IS DOING WELL AND ONLY COMPLAINED OF A SORE THROAT AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858895 LINX REFLUX MANAGEMENT SYSTEM ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LS12 3570 00855106005011

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| S