BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 11504942 · Received March 17, 2021

    Report

    Report Number
    3008766073-2021-00040
    Event Type
    Injury
    Date Received
    March 17, 2021
    Date of Event
    March 8, 2021
    Report Date
    March 8, 2021
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN; CAPTURED AS AWARENESS DATE THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: ESSENTIALS OF LAPAROSCOPIC REMOVAL OF MAGNETIC LES AUGMENTATION DEVICE (LINX), REDO HIATAL HERNIA REPAIR AND TOUPET FUNDOPLICATION FOR RECURRENT GERD AUTHOR: SHIN THOMAS, JAD KHORAKI, GUILHERME CAMPOS CITATION: NOT REPORTED DOI: NOT REPORTED THIS CASE PRESENTS A PATIENT WITH RECURRENT GERD. A PATIENT HAD LINX FAILURE PRESENTED AS A RECURRENT GERD, 17 MONTHS AFTER LINX AND THE DEVICE WAS REMOVED. THE REMOVAL OF THE DEVICE SHOULD ONLY BE ATTEMPTED AFTER COMPLETE DISSECTION OF GE JUNCTION AND DISTAL ESOPHAGUS. OTHER TECHNICAL STEPS HIGHLIGHTED IN THE VIDEO INCLUDE THE USE OF ENERGY TO UNEARTH THE LINX FROM ITS CAPSULE, HIATUS CLOSURE, FUNDUS MOBILIZATION, AND A TOUPET FUNDOPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403023 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention