BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 22793129 · Received August 13, 2025

    Report

    Report Number
    3008766073-2025-00112
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    January 1, 2024
    Report Date
    August 13, 2025
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 8/13/2025. D4: BATCH # UNK. ONLY EVENT YEAR KNOWN: 2024. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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

    IT WAS REPORTED VIA JOURNAL ARTICLE: THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: JEFFERIES RS, WARD MA, SHABBIR R, FARIAS DA, OGOLA GO, LEEDS SG. MAGNETIC SPHINCTER AUGMENTATION VS SUBTOTAL GASTRECTOMY WITH ROUX-EN-Y RECONSTRUCTION FOR THE TREATMENT OF POSTSLEEVE GASTRECTOMY GASTROESOPHAGEAL REFLUX DISEASE. J GASTROINTEST SURG. 2024 OCT;28(10):1682-1686. DOI: 10.1016/J.GASSUR.2024.07.016. EPUB 2024 AUG 15. PMID: 39152086. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO BRIDGE THIS GAP BY OFFERING A COMPREHENSIVE COMPARISON OF POSTOPERATIVE OUTCOMES BETWEEN MSA AND SGRY FOR POST-SG GERD. SPECIFICALLY, IT COMPARED THE POSTOPERATIVE OBSERVATION FINDINGS OF PATIENTS WHO UNDERWENT SG FOLLOWED BY MSA WITH THOSE WHO UNDERWENT SG FOLLOWED BY SGRY. BETWEEN 2018 TO 2023, A TOTAL OF 92 PATIENTS WERE INCLUDED IN THE STUDY. THESE PATIENTS DIVIDED INTO TWO GROUPS: MSA GROUP (N=18) CONSISTS OF 15 FEMALE AND 3 MALE WITH THE MEAN AGE OF 55.1 (9.7) YEARS. TREATED WITH MAGNETIC SPHINCTER AUGMENTATION WHILE SGRY (N=74) WITH 70 FEMALE AND 4 MALE AND THE MEAN AGE OF 49.6 (11.9) YEARS, TREATED WITH ROUX-EN-Y RECONSTRUCTION SGRY, RESPECTIVELY. FOLLOW UP WERE UNKNOWN. REPORTED COMPLICATIONS: LINX® REFLUX MANAGEMENT SYSTEM (ETHICON ENDO SURGERY) -REQUIRED REOPERATION DUE TO ODYNOPHAGIA (N=1) IN CONCLUSIONS, ALTHOUGH MSA REMAINS A VIABLE SURGICAL ALTERNATIVE, THE STUDY INDICATED THAT SGRY CAN PRODUCE BETTER SYMPTOM CONTROL AND DECREASE ACID EXPOSURE COMPARED WITH MSA IN PATIENTS WITH POST-SG GERD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763164 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention