BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX 1.5T 14 BEAD OUS

    MDR report key: 16435369 · Received February 24, 2023

    Report

    Report Number
    3008766073-2023-00030
    Event Type
    Injury
    Date Received
    February 24, 2023
    Date of Event
    February 10, 2023
    Report Date
    March 15, 2023
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 3/15/2023 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER 29442, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    (B)(4). AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. LOT NUMBER WAS RECEIVED AND DHR IS PENDING REVIEW. WHEN THE REVIEW IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT WITH A SUMMARY OF THE EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: PRIOR TO LINX PLACEMENT, DID THE PATIENT HAVE AN EGD, PH, AND MANOMETRY STUDIES DONE? IF YES, COULD YOU PLEASE SHARE THE RESULTS? YES. DETAILS SHOULD BE REQUESTED FROM DR (B)(6). TO SUMMARIZE, DEMEESTER SCORE OF 38. DEA OF 45MMHG WITH VISCOUS SWALLOWS. 60% OF BOLUS VISCOUS SWALLOWS WERE COMPLETELY TRANSMITTED. DCI OF 865. IRP 13. ON WHAT DATE DID THE IMPLANT TAKE PLACE? (B)(6) 2022. WHAT IS THE LOT NUMBER OF THE LINX DEVICE? 29442. WHEN USING THE LINX SIZING DEVICE WHAT TECHNIQUE WAS USED TO DETERMINE THE SIZE? WAND SIZING DEVICE. OPENED AT 11. SIZE 14 USED. DID THE PATIENT HAVE AN AUTOIMMUNE DISEASE? NO. IS THE PATIENT CURRENTLY TAKING STEROIDS / IMMUNOSUPPRESSIVE DRUGS? NO. DID THE PATIENT HAVE ANY PRE-EXISTING DYSPHAGIA OR OTHER CONDITIONS (OTHER THAN GERD)? NO. HOW SEVERE WAS THE DYSPHAGIA/ODYNOPHAGIA BEFORE INTERVENTION?N/A. WERE THERE ANY INTRA-OPERATIVE COMPLICATIONS DURING IMPLANT? NO. WAS THERE ANY HIATAL OR CRURAL REPAIR DONE AT THE SAME TIME AS THE IMPLANT? YES. WERE THERE ANY OTHER CONTRIBUTING FACTORS THAT LED TO THE REMOVAL OF THE DEVICE OTHER THAN THE REPORTED DYSPHAGIA? NO. BESIDES THE REPORTED DYSPHAGIA, WHAT WAS THE REASON FOR REMOVAL OF THE LINX DEVICE? DYSPHAGIA. WAS THE DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY AT THE TIME OF REMOVAL? YES. MSO COMMENTS ABOUT PHOTO THAT WAS PROVIDED IN FILE : THE PHOTOS ARE NOT OF A QUALITY THAT ALLOWS INTERPRETATION. THE OPERATIVE REPORT DESCRIBES A ¿STRICTURE¿ AND DILATION. THIS COULD REPRESENT A TRUE ESOPHAGEAL STRICTURE OR THE EFFECT OF A FUNCTIONING LINX DEVICE AT THE GE JUNCTION. 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 THAT THE PATIENT HAD DYSPHAGIA SO THE ENTIRE LINX DEVICE WAS REMOVED. NISSEN WAS PERFORMED. UNKNOWN OF PATIENT'S SYMPTOMS SINCE EXPLANT. IMPLANT DATE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858476 LINX 1.5T 14 BEAD OUS ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LOT 29442

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male Required Intervention