BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5T LINX, 14B

    MDR report key: 15086382 · Received July 22, 2022

    Report

    Report Number
    3008766073-2022-00146
    Event Type
    Injury
    Date Received
    July 22, 2022
    Date of Event
    January 1, 2022
    Report Date
    June 1, 2023
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    UDI-DI
    00855106005349
    PMA / PMN Number
    P100049
    Removal / Correction Number
    Z-2038-2018
    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. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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. LINX PHOTO IMAGES WERE RECEIVED AND ARE PENDING REVIEW. WHEN THE REVIEW IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT WITH A SUMMARY OF THE EVALUATION. 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: WHEN DID THE COUGHING BEGIN? WHAT WAS THE DATE OF THE UPPER GI WHICH SHOWED THE DISCONTINUOUS LINX? IF AVAILABLE, PLEASE SHARE A COPY OF THE RESULTS BE SHARED WITH US? WAS THE DEVICE INITIALLY EFFECTIVE IN CONTROLLING REFLUX? WERE ANY EVENTS ASSOCIATED WITH THE ONSET OF SYMPTOMS (VOMITING, RETCHING, TRAUMA, SURGERY)? DID THE PATIENT UNDERGO AN MRI SINCE DEVICE IMPLANT? IF SO, WHEN WAS THE MRI AND WHAT STRENGTH? DID THE PATIENT HAVE ANY OTHER SURGERIES IN THE AREA? WAS ANY ADDITIONAL IMAGING PERFORMED SINCE DEVICE IMPLANT? DOES THE DEVICE APPEAR TO BE IN A CONTINUOUS ANNULAR STATE IN THESE IMAGES? WE ARE INTERESTED IN ESTABLISHING A WINDOW WHEN THE DEVICE MAY HAVE BECOME DISCONTINUOUS. PLEASE SHARE ANY ADDITIONAL IMAGES. WHAT IS THE MANAGEMENT PLAN? IS DEVICE REMOVAL SCHEDULED? IS A REPLACEMENT LINX OR FUNDOPLICATION PLANNED? WHEN AND IF THE EXPLANATION TAKES PLACE CAN WE ASK THAT THE PROCEDURE GETS VIDEO RECORDED AND THE VIDEO SHARED? WHEN AND IF THE LINX DEVICE IS REMOVED, MAY WE ASK THAT THE DEVICE BE RETURNED FOR ANALYSIS? 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: 11/22/2022. LOT 14042 WAS AN AFFECTED LOT OF THE 2018 LINX RECALL H10, H7, H9.

    Additional Manufacturer Narrative · 0

    (B)(4), DATE SENT: 9/13/2022.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 8/5/2022 SPOKE WITH (B)(6) IN DR. (B)(6) OFFICE WHO INDICATED THE PATIENT RECEIVED A REPLACEMENT DEVICE. THE EXPLANTED DEVICE IS BEING RETURNED FOR ANALYSIS AND SHE WILL PROVIDE THE PATIENT WITH MY CONTACT INFORMATION. SALES REP IS WORKING ON OBTAINING THE ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    (B)(4); DATE SENT: 5/2/2023. SEE ATTACHED OP NOTES.

    Additional Manufacturer Narrative · 0

    (B)(4); DATE SENT: 11/22/2022. PHOTO ANALYSIS: THE PHOTOS WERE REVIEWED BY A MEDICAL SAFETY OFFICER. AS PER MEDICAL SAFETY OFFICER: "THE IMAGE APPEARS TO SHOW A DISCONTINUOUS DEVICE THAT MAY OR MAY NOT BE LOCATED BELOW THE DIAPHRAGM.". A HANDS-ON ANALYSIS IS NECESSARY TO DETERMINE THE CAUSE OF FAILURE. INVESTIGATION ANALYSIS: A LINX DEVICE WITH A VISIBLE WELD BALL THAT DISCONNECTED FROM A WASHER WAS RETURNED TO THE ANALYSIS SITE. THE LINK LENGTH AND TENSILE FORCE MEASUREMENTS WERE FOUND TO MEET THE APPLICABLE SPECIFICATIONS DURING DEVICE ANALYSIS. THE REMAINING DEVICE CHARACTERISTICS, EXCEPTING THE VISIBLE WELD BALL, SHOW NO ANOMALIES FOR A DEVICE THAT HAS BEEN REASONABLY CHANGED AS PART OF THE EXPLANT PROCEDURE. THE DEVICE WAS SCANNED USING COMPUTER TOMOGRAPHY (CT), OPTICAL MICROSCOPY, AND SCANNING ELECTRON MICROSCOPY. THE WASHER THROUGH-HOLE AT THE SEPARATION WAS MEASURED AND WAS GREATER THAN THE SPECIFICATION. THE WASHER THROUGH-HOLE WAS CONCENTRIC WITH SMALL AMOUNT OF MATERIAL DISPLACEMENT AT THE OUTER EDGE OF THE THROUGH HOLE. THE OVERALL APPEARANCE OF THE SURFACE OF THE WASHER THROUGH HOLE DIDN¿T EXHIBIT GROSS LOSS OF SHAPE. THE TOP VIEW OF THE DIAMETER OF THE EXPOSED WELD BALL WAS MEASURED. THIS DIAMETER IS WITHIN THE SPECIFICATION. THE WELD BALL WAS CONCENTRIC WITH THE RESPECT TO THE WIRE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER 14042, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 6/1/2023. D6A: IMPLANT DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A LINX DEVICE IS BEING EXPLANTED BECAUSE THE PATIENT DEVELOPED A LOT OF COUGHING. AN UPPER GI REVELED THE BEAD IS COMPLETELY OPEN. A NEW DEVICE WILL BE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116370 1.5T LINX, 14B ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LXMC14 14042 00855106005349

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention