BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 17277428 · Received July 7, 2023

    Report

    Report Number
    3008766073-2023-00144
    Event Type
    Injury
    Date Received
    July 7, 2023
    Date of Event
    April 17, 2023
    Report Date
    July 7, 2023
    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: 7/7/2023. 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. 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

    TITLE: MAGNETIC ESOPHAGEAL SPHINCTER AUGMENTATION WITH THE LINX(R)-DEVICE PREPARED BY USING A ROBOTIC ASSISTED SURGICAL SYSTEM. AUTHORS: ERNST WOLFGANG KOLBE, CARMEN KIRCHNER, SABINE LEERHOFF, GÜNTHER WINDE. CITATION CITE: EUR SURG RES 2023;64(SUPPL 1):1¿96. DOI: 10.1159/000529900. THE AUTHOR'S OBJECTIVE IS TO PERFORM A OF SHORT-TERM RETROSPECTIVE STUDY OF ALL PATIENTS SUFFERING FROM REFLUX ESOPHAGITIS WITH AXIAL HIATAL HERNIA WHO UNDERWENT MSA WITH THE LINX-SYSTEM AND USING A ROBOTASSISTED OPERATION SYSTEM (DA VINCI XI, INTUITIVE SURGICAL INC., SUNNYVALE, CA, US) TO PERFORM THE HIATAL PREPARATION AND TO PLACE THE MSA-SYSTEM CALLED LINX®-DEVICE. FROM JUNE 2021 TO JANUARY 2022, 23 PATIENTS WITH MATCHING CRITERIA AND ESOPHAGEAL REFLUX WERE INCLUDED, OUT OF THEM 10 ARE MALES AND 13 ARE FEMALES. MEAN AGE WAS 58,7 ± 10,3 YEARS, BODY MASS INDEX WAS 28,8 ±.2,9 KG/M². GASTROESOPHAGEAL REFLUX DISEASE-HEALTH RELATED QUALITY OF LIFE-SCORE (GERD-HRQL) WAS COLLECTED PREOPERATIVELY, AT THE DAY OF DISMISSION AND 6 MONTHS POSTOPERATIVELY. GERD-HRQL-SCORE WAS REDUCED FROM PREOPERATIVELY 19,6 ± 12,3 TO 1,8 ± 2,6 POSTOPERATIVELY (P= 0,0004) AND 3,2 ± 3,3 AFTER SIX MONTHS (P=0,0005). THE REDUCTION OF THE DAILY PPI MEDICATION WAS OBSERVED IN ALL PATIENTS. COMPLICATIONS MENTIONED IN THE ARTICLE WERE DURING SIX-MONTHS ONE PATIENT NEEDED TEMPORARY METHYLPREDNISOLONE MEDICATION, ANOTHER ONE SUFFERED FROM DYSPHAGIA UNTIL BEING DILATED VIA ENDOSCOPY. IN CONCLUSION, THE OVERALL OPERATION TIME BY USING THE ROBOTIC ASSISTED SYSTEM WAS LITTLE HIGHER THAN DESCRIBED FOR LAPAROSCOPIC PROCEDURES. IN ALL PATIENTS OF THIS SHORT OUT-COME-INVESTIGATION SHOWS DIMINISHED SYMPTOMS FOR REFLUX ESOPHAGITIS AND NO MAJOR COMPLICATIONS OCCURRED IN THIS SERIES, CLEARLY DEMONSTRATING FEASIBILITY. TO THE AUTHOR'S KNOWLEDGE, THIS IS THE FIRST DESCRIPTION OF USING A ROBOTIC SYSTEM FOR CRURAL REPAIR OF THE DIAPHRAGM AND INSERTION OF A MSA SYSTEM IN AXIAL HERNIAS OF VARYING SIZES UP TO 7 CM IN DIAMETER. FURTHER SOME RANDOM CONTROLLED STUDIES ARE NEEDED TO PROVE THESE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2029988 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention