BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX REFLUX MANAGEMENT SYSTEM

    MDR report key: 6073434 · Received November 2, 2016

    Report

    Report Number
    3008766073-2016-00078
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    July 12, 2016
    Report Date
    October 29, 2018
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    UDI-DI
    00855106005011
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED EVENT TO INCLUDE START OF SYMPTOMS AND CONTINUED PATIENT STATUS. UPDATED REPORT DATE.

    Description of Event or Problem · 0

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE, A PATIENT EXPERIENCED REFLUX, DYSPHAGIA AND ODYNOPHAGIA SYMPTOMS LEADING TO ENDOSCOPIC VISUALIZATION OF TWO LINX DEVICE BEADS WITHIN THE ESOPHAGEAL LUMEN IN (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) 2012. THE PATIENT BEGAN EXPERIENCING PAINFUL SWALLOWING AND TROUBLE SWALLOWING IN (B)(6) 2016. IT WAS REPORTED THAT THE PATIENT'S FOOD NEEDED TO BE PUREED, AND THAT THEY LOST WEIGHT. ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED IN (B)(6) 2016 DUE TO REFLUX, DYSPHAGIA, AND ODYNOPHAGIA SHOWED TWO LINX DEVICE BEADS IN THE ESOPHAGEAL LUMEN. UNEVENTFUL ENDOSCOPIC EXPLANT OF 3 LINX DEVICE BEADS ON (B)(6) 2016 AFTER PATIENT SECURED HEALTH INSURANCE. THE PHYSICIAN REMOVED THE REMAINING 9 BEADS ON (B)(6) 2016 AND REPORTED THAT "ALL WENT WELL," DURING THE EXPLANT. ON (B)(6)2016 THE PATIENT WAS REPORTED AS DOING WELL WITH "NO PROBLEMS" AFTER DEVICE EXPLANT. ON (B)(6)2018, IT WAS REPORTED THAT THE PATIENT CONTINUED TO HAVE DYSPHAGIA AND ODYNOPHAGIA AFTER DEVICE REMOVAL AND HAS BEEN UNABLE TO WORK.

    Additional Manufacturer Narrative · 1

    UPDATED NARRATIVE INCLUDES: -THE PHYSICIAN LAPAROSCOPICALLY REMOVED THE REMAINING 9 BEADS ON (B)(6) 2016 AND REPORTED THAT "ALL WENT WELL," DURING THE EXPLANT. -ON (B)(6) 2016 THE PATIENT WAS REPORTED AS DOING WELL WITH "NO PROBLEMS" AFTER DEVICE EXPLANT. UPDATED NARRATIVE INCLUDES: -24 HOURS AFTER REMOVAL OF THE REMAINING 9 LINX DEVICE BEADS THE PATIENT UNDERWENT A BARIUM SWALLOW IN WHICH THE PATIENT'S UGI "LOOKED FINE;" THE PATIENT WAS THEN DISCHARGED.

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE A PATIENT EXPERIENCED REFLUX, DYSPHAGIA AND ODYNOPHAGIA SYMPTOMS LEADING TO ENDOSCOPIC VISUALIZATION OF TWO LINX DEVICE BEADS WITHIN THE ESOPHAGEAL LUMEN IN (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) 2012. -ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED IN (B)(6) 2016 DUE TO REFLUX, DYSPHAGIA, AND ODYNOPHAGIA SHOWED TWO LINX DEVICE BEADS IN THE ESOPHAGEAL LUMEN. -UNEVENTFUL ENDOSCOPIC EXPLANT OF 3 LINX DEVICE BEADS ON (B)(6) 2016 AFTER PATIENT SECURED HEALTH INSURANCE. THE PHYSICIAN PLANS TO LAPAROSCOPICALLY REMOVE THE REMAINDER OF THE DEVICE IN 3-4 MONTHS. -PATIENT IN SATISFACTORY CONDITION AFTER EXPLANT.

    Description of Event or Problem · 1

    FOLLOWING A LAPAROSCOPIC ANTI-REFLUX PROCEDURE A PATIENT EXPERIENCED REFLUX, DYSPHAGIA AND ODYNOPHAGIA SYMPTOMS LEADING TO ENDOSCOPIC VISUALIZATION OF TWO LINX DEVICE BEADS WITHIN THE ESOPHAGEAL LUMEN IN (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) 2012. -ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED IN (B)(6) 2016 DUE TO REFLUX, DYSPHAGIA, AND ODYNOPHAGIA SHOWED TWO LINX DEVICE BEADS IN THE ESOPHAGEAL LUMEN. -UNEVENTFUL ENDOSCOPIC EXPLANT OF 3 LINX DEVICE BEADS ON (B)(6) 2016 AFTER PATIENT SECURED HEALTH INSURANCE. -THE PHYSICIAN REMOVED THE REMAINING 9 BEADS ON (B)(6) 2016 AND REPORTED THAT "ALL WENT WELL," DURING THE EXPLANT. -ON (B)(6) 2016 THE PATIENT WAS REPORTED AS DOING WELL WITH "NO PROBLEMS" AFTER DEVICE EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724388 LINX REFLUX MANAGEMENT SYSTEM ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LS12 3457 00855106005011

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| S