BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 19104221 · Received April 15, 2024

    Report

    Report Number
    3008766073-2024-00065
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Date of Event
    January 1, 2023
    Report Date
    April 15, 2024
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    P100049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 4/15/2024 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

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: MANAGEMENT OF GASTROESOPHAGEAL REFLUX DISEASE POST BARIATRIC SURGERY USING LINX: ONE-YEAR OUTCOMES AUTHOR'S: ADI, ET AL. CITATION: THE STUDY AIMED TO REVIEW THE OUTCOMES OF PATIENTS WHO COMPLETED AT LEAST OF ONE YEAR FOLLOW UP USING LINX POST BARIATRIC SURGERY INCLUDING SLEEVE GASTRECTOMY. WE REVIEWED THE OUTCOMES OF OUR PATIENTS WHO COMPLETED AT LEAST OF ONE YEAR FOLLOW UP USING LINX POST BARIATRIC SURGERY INCLUDING SLEEVE GASTRECTOMY, ONE ANASTOMOSIS GASTRIC BYPASS AND RY GASTRIC BYPASS. RESULTS THIRTEEN PATIENTS WERE OPERATED (11 FEMALE AND 2 MALE) WITH AGE OF 21- 51 YEAR. BMI WAS 19.1- 30 KG/M 2 AT TIME OF SURGERY. THE INDEX SURGERY WAS 9 SG, 3 RYGB (ONE OF THEM WAS CONVERTED FROM SG TO RYGB BEFORE SHE HAD LINX INSERTED) AND 1 OAGB. INTERVAL PERIOD FROM INDEX BARIATRIC SURGERY WAS 19 -52 MONTHS. GERD- HRQL SCORE IMPROVED FROM 47.9 +/-7.61/75 TO 12.61 +/-9.54/75. DURING THE SURGERY, LINX (ETHICON) WAS USED FOR THE MAGNETIC SPHINCTER AUGMENTATION. THE REPORTED COMPLICATION INCLUDED (N=1) DYSPHAGIA TREATMENT; STEROIDS AND (N=1) RECURRENT GERD AND RECURRENT REFLUX TREATMENT; NOT MENTIONED. IN CONCLUSION, USING LINX FOR MANAGEMENT OF GERD POST BARIATRIC SURGERY IS SAFE. IT CAN BE A TOOL IN ARMAMENTARIUM OF TREATMENT OF REFLUX AFTER BARIATRIC SURGERY SPECIALLY FOR THOSE WITH GERD AND MAINTAINED LOW BMI AFTER THEIR BARIATRIC PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836876 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown