BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINX 1.5 16 BEAD US

    MDR report key: 15710370 · Received November 1, 2022

    Report

    Report Number
    3008766073-2022-00215
    Event Type
    Injury
    Date Received
    November 1, 2022
    Date of Event
    January 1, 2022
    Report Date
    December 7, 2022
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    UDI-DI
    00855106005363
    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). EVENT DATE: ONLY EVENT YEAR KNOWN: 2022. NO LOT NUMBER WAS PROVIDED THEREFORE A DEVICE HISTORY COULD NOT BE DONE. 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: WHAT IS THE LOT NUMBER? WHEN IS THE DATE OF THE LINX EXPLANT SCHEDULED? WERE THERE ANY INTRA-OPERATIVE COMPLICATIONS DURING IMPLANT? 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: 12/7/2022. INVESTIGATION SUMMARY: 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. H6 TYPE OF INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A LINX DEVICE WAS IMPLANTED 1.5T IN (B)(6) 2020 - WITH REPAIR OF PEH AND TAKEDOWN OF NISSEN DUE TO SIDE EFFECTS OF NISSEN. RECURRENT HERNIA (B)(6) 2021 REPAIRED, LINX LEFT. SEVERE GASTROPARESIS DEVELOPED AFTER (B)(6) 2021 PEH REPAIR, SUBSEQUENT SEVERE REFLUX AND DYSPHAGIA DUE TO SMALL RECURRENT HERNIA. PATIENT REQUESTED REPAIR OF RECURRENT HH AND CONVERSION TO ANTERIOR FUNDO WITH LINX REMOVAL; PATIENT WILL UNDERGO GASTRIC SURGERY FOR GASTROPARESIS IN 6 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438314 LINX 1.5 16 BEAD US ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LXMC16 00855106005363

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female Required Intervention