BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 9139528 · Received October 1, 2019

    Report

    Report Number
    3008766073-2019-00488
    Event Type
    Injury
    Date Received
    October 1, 2019
    Report Date
    September 17, 2019
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 10/01/2019. DATE OF EVENT: UNKNOWN. IMPLANT DATE: (B)(6) 2013. THE LOT WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: ENDOSCOPIC REMOVAL OF AN ERODED MAGNETIC SPHINCTER AUGMENTATION DEVICE. AUTHOR/S: BALDWIN PO MAN YEUNG, GRANT FULLERTON. CITATION: ENDOSCOPY 2017; 49: 718¿719 / HTTPS://DOI.ORG/10.1055/S-0043-109236. THE PURPOSE OF THIS CASE REPORT WAS TO PRESENT ENDOSCOPIC REMOVAL OF AN ERODED MAGNETIC SPHINCTER AUGMENTATION DEVICE. THIS IS A CASE OF A (B)(6)-YEAR-OLD WOMAN WITH GERD WHO UNDERWENT 12-BEAD LINX IMPLANTATION IN APR 2013. IN (B)(6) 2017, THE PATIENT EXPERIENCED ACUTE INTERMITTENT DYSPHAGIA AND CHEST PAIN. ENDOSCOPY SHOWED DEVICE EROSION. THE LINX DEVICE WAS DIVIDED AT TWO POINTS USING A LOOP CUTTER AND WAS EXTRACTED ENDOSCOPICALLY USING A GRASPER WITH THE APPLICATION OF ROTATIONAL TRACTION. THE MUCOSAL DEFECTS IN THE ESOPHAGUS WERE CLOSED WITH TWO OLYMPUS QUICKCLIPS. THE PATIENT WAS DISCHARGED WITH PROTON PUMP INHIBITORS ON POSTOPERATIVE DAY 1 AFTER A NORMAL ORAL CONTRAST SWALLOW STUDY WHICH CONFIRMED ESOPHAGEAL INTEGRITY AFTER REMOVAL OF THE LINX DEVICE. WE PRESENT THE FIRST CASE OF LINX EROSION IN THE UNITED KINGDOM AND ITS ENDOSCOPIC REMOVAL USING OLYMPUS LOOP CUTTERS. WE DEMONSTRATED THAT AN ENDOSCOPIC APPROACH TO LINX REMOVAL IN THIS CASE IS POSSIBLE WITH MINIMAL MORBIDITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934432 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1