BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 13314054 · Received January 21, 2022

    Report

    Report Number
    3008766073-2022-00020
    Event Type
    Injury
    Date Received
    January 21, 2022
    Date of Event
    March 9, 2021
    Report Date
    January 21, 2022
    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 · 0

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY 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 · 0

    TITLE: REFERENCE HIGH-RESOLUTION MANOMETRY VALUES AFTER MAGNETIC SPHINCTER AUGMENTATION. AUTHORS: STEFANO SIBONI, DAVIDE FERRARI, CARLO GALDINO RIVA, MARCO SOZZI, VERONICA LAZZARI, VALENTINA MILANI, LUIGI BONAVINA. CITATION CITE: NEUROGASTROENTEROLOGY & MOTILITY. 2021;00:E14139. HTTPS://DOI.ORG/10.1111/NMO.14139. THE AIM OF THE PRESENT STUDY WAS TO DESCRIBE HRM FEATURES OF PATIENTS AFTER MSA IMPLANTATION AND TO DEFINE REFERENCE VALUES. A RETROSPECTIVE, OBSERVATIONAL COHORT STUDY WAS CONDUCTED AT OUR TERTIARY CARE HOSPITAL AND REFERRAL CENTER FOR ESOPHAGEAL SURGERY. AFTER INSTITUTIONAL REVIEW BOARD APPROVAL, THE PROSPECTIVELY COLLECTED ANTIREFLUX SURGERY DATABASE WAS REVIEWED TO IDENTIFY ALL INDIVIDUALS WHO RECEIVED MSA (LINX REFLUX MANAGEMENT SYSTEM, ETHICON, JOHNSON & JOHNSON). DURING THE STUDY PERIOD, 105 PATIENTS UNDERWENT MSA WITH OR WITHOUT CRURAL REPAIR. REPORTED COMPLICATION INCLUDED DYSPHAGIA AND HIGH-RESOLUTION MANOMETRY (HRM) WAS PERFORMED AFTER ENDOSCOPIC DILATATION. IN CONCLUSION HIGH-RESOLUTION MANOMETRY (HRM) REFERENCE VALUES IN PATIENTS WHO UNDERWENT SUCCESSFUL LAPAROSCOPIC MSA DEVICE IMPLANTATION FOR GERD. THE CRURAL REPAIR IS A KEY COMPONENT OF THE RESISTIVE FORCE AT THE EGJ AND MAY ACCOUNT FOR THE INCREASED IRP AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857706 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention