BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 22714406 · Received August 5, 2025

    Report

    Report Number
    3008766073-2025-00100
    Event Type
    Injury
    Date Received
    August 5, 2025
    Date of Event
    July 16, 2024
    Report Date
    August 5, 2025
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 8/5/2025. 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.

    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: IBACH MJ, DAHLKE PM, WIEGREBE S, HENTSCHEL F, SIEMSSEN B. MEDIUM-TERM OUTCOMES AFTER MAGNETIC SPHINCTER AUGMENTATION VS. FUNDOPLICATION FOR REFLUX DISEASE DUE TO HIATAL HERNIA: A PROPENSITY-SCORE MATCHED COMPARISON IN 282 PATIENTS. SURG ENDOSC. 2024 SEP;38(9):5068-5075. DOI: 10.1007/S00464-024-11011-6. EPUB 2024 JUL 16. PMID: 39014181. THE AIM OF THIS STUDY IS TO FURTHER IMPROVE CLINICAL EFFICACY AND EXPAND THERAPEUTIC OPTIONS, SURGEONS HAVE INCREASINGLY EMPLOYED AN ALTERNATIVE TECHNIQUE OVER THE LAST DECADE: MAGNETIC SPHINCTER AUGMENTATION (MSA). BETWEEN JANUARY 2015 AND JUNE 2020, OUT OF 411 ELIGIBLE PATIENTS, 141 PATIENTS WHO UNDERWENT MSA AND 141 WITH FUNDOPLICATION. PATIENTS UNDERWENT SURGERY, INCLUDING HIATOPLASTY, FOR MEDICAL TREATMENT-RESISTANT REFLUX DUE TO HIATAL HERNIA AND WAS DIVIDED INTO TWO GROUPS THE MSA GROUP HAS 57 MALES WITH THE MEAN AGE OF 54.58 [11.95] YEARS AND FUNDO GROUP HAS 52 MALES WITH THE MEAN AGE OF 55.15 [11.46] YEARS. THE MEAN DURATION FOLLOW-UP WAS AT 3.9 YEARS. REPORTED COMPLICATIONS: LINX REFLUX MANAGEMENT SYSTEM (ETHICON ENDO SURGERY): (N=1) ABDOMINAL WALL HEMORRHAGE DURING PRIMARY STAY. TREATMENT: RESOLVED WITHOUT INTERVENTION. (N=1) WOUND INFECTION DURING PRIMARY STAY. TREATMENT: ORAL ANTIBIOTICS. (N=1) ESOPHAGEAL LESION DURING PRIMARY STAY. TREATMENT: SURGICAL REVISION. (N=14) ABDOMINAL BLOATING/FLATULENC AFTER DISCHARGE. TREATMENT: NOT REPORTED. (N=17) DYSPHAGIA AFTER DISCHARGE. TREATMENT: NOT REPORTED. (N=3) DYSPHAGIA (SEVERE) CONSIDERED AS SERIOUS AE. TREATMENT: SURGICAL REVISION. (N=1) ABDOMINAL DISCOMFORT (UNSPECIFIED) CONSIDERED AS SERIOUS AE. TREATMENT: SURGICAL REVISION. IN CONCLUSION, MSA REDUCES THE RISK OF RE-OPERATION AND MAY REDUCE ADVERSE EVENT RATES COMPARED TO FUNDOPLICATION. OPTIMIZING MAGNETIC DEVICE SIZE COULD MAINTAIN LOW GAS/BLOATING RATES WHILE PREVENTING SEVERE DYSPHAGIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2633553 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention