BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 22394009 · Received July 3, 2025

    Report

    Report Number
    3008766073-2025-00088
    Event Type
    Injury
    Date Received
    July 3, 2025
    Date of Event
    October 14, 2024
    Report Date
    July 7, 2025
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/3/2025. D4: BATCH # UNK. 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.

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 7/7/2025 CORRECTED DATA: B1, B2, H1. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? -NO UPON REVIEW OF THE INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT AND IS BEING CONSIDERED NOT REPORTABLE.

    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: ZHU Z, MAO J, ZHOU M, XIA M, WU J, CHEN Q, ZHAO F, LIANG H, WANG Z. A COMPARATIVE STUDY OF MAGNETIC SPHINCTER AUGMENTATION AND NISSEN FUNDOPLICATION IN THE MANAGEMENT OF GERD. HERNIA. 2024 DEC;28(6):2367-2374. DOI: 10.1007/S10029-024-03172-Z. EPUB 2024 OCT 14. PMID: 39400916; PMCID: PMC11530483. THE AIM OF THIS STUDY IS TO EXPLORE THE SAFETY AND EFFICACY OF MSA COMPARED WITH LAPAROSCOPIC NISSEN FUNDOPLICATION (LNF) FOR GERD TREATMENT. A TOTAL OF 40 ELIGIBLE PATIENTS WERE INCLUDED IN THIS STUDY, INCLUDING 16 MSA CASES AND 24 LNF CASES. AGE (YEAR) [MSA: 40.19±9.40; LNF: 46.88±16.83]; GENDER (% MALE) [MSA: 50; LNF: 62.5]. MAGNETIC SPHINCTER AUGMENTATION (MSA), WHICH RECEIVED FDA APPROVAL IN 2012 [4], UTILIZES THE LINX SYSTEM TO ENHANCE LOWER ESOPHAGEAL SPHINCTER (LES) PRESSURE, ACHIEVING AN ANTI-REFLUX EFFECT. REPORTED COMPLICATIONS ARE: -POSTOPERATIVE ANXIETY AND HAD MINOR REFLUX (N=2) TREATMENT: WITH THE PATIENT¿S PERMISSION, PRESERVING SURGICAL FOOTAGE AND RECORDING PHOTOGRAPHS CAN HELP REDUCE POSTOPERATIVE DISCOMFORT AND ANXIETY. -ANY DYSPHAGIA (N=43.75%) TREATMENT: NO CASES REQUIRED ENDOSCOPIC DILATION -ABILITY OF HICCUP (N=87.5%) TREATMENT: NOT REPORTED -UPPER ABDOMINAL DISCOMFORT TREATMENT: NOT REPORTED -CHEST PAIN TREATMENT: UNDERWENT A SECOND SURGICAL PROCEDURE AT A DIFFERENT FACILITY TO REMOVE THE MSA DEVICE. IN CONCLUSION, BOTH LNF AND MSA ARE SAFE AND SUCCESSFUL SURGICAL THERAPIES FOR GERD. THE BENEFITS OF MSA INCLUDE REDUCED SURGICAL TIME, QUICKER NUTRITIONAL RECOVERY FOLLOWING SURGERY, AND PRESERVATION OF HICCUP CAPACITY. HOWEVER, WITH BOTH SURGERIES, POSTOPERATIVE DYSPHAGIA IS A PREVALENT PROBLEM THAT EMPHASIZES THE SIGNIFICANCE OF IMPROVING PREOPERATIVE COMMUNICATION. WHEN SELECTING BETWEEN TWO SURGICAL TECHNIQUES, IT IS CRUCIAL TO CONSIDER THE POSTOPERATIVE SYMPTOMS ASSOCIATED WITH EACH PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188089 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention