BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5T LINX, 13B

    MDR report key: 12330918 · Received August 17, 2021

    Report

    Report Number
    3008766073-2021-00171
    Event Type
    Injury
    Date Received
    August 17, 2021
    Date of Event
    January 1, 2021
    Report Date
    August 3, 2021
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    UDI-DI
    00855106005332
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 8/18/2021. ADDITIONAL INFORMATION: UPON REVIEW IT WAS IDENTIFIED THAT THIS IS A DUPLICATE REPORT. ALL REPORTED INFORMATION FOR THIS EVENT WAS REPORTED UNDER 3008766073-2019-00542.

    Additional Manufacturer Narrative · 1

    (B)(4). ONLY EVENT YEAR KNOWN: 2021. PHOTO WAS PROVIDED FOR REVIEW BY ETHICON MEDICAL SAFETY OFFICER. FOLLOWING ARE THEIR OBSERVATIONS: I REVIEWED A LATERAL AND AP X-RAY IMAGE OF THE PATIENT REFERRED TO IN THE COMPLAINT. THE XRAY IMAGE SHOWED A DISCONTINUOUS CLASP LINX DEVICE. THE ANNULAR SHAPE WAS ABSENT, THE BEADS WERE SEPARATED AND NOT IN THE SAME PLANE CONSISTENT WITH A DISCONTINUOUS DEVICE. 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: WHAT WAS THE DATE OF IMPLANT? (B)(6) 2017. WHAT SYMPTOMS LEAD TO THE DISCOVERY OF THE DISCONTINUOUS DEVICE? WHEN DID THEY BEGIN? ON (B)(6) 2019 PATIENT WENT TO ER FOR CHEST PAIN AND WHEN THEY DID AN X-RAY THEY NOTICED THE DEVICE WAS OPEN. PATIENT WAS DIAGNOSED WITH FLU. WHAT IS THE DEVICE LOT NUMBER? 14973. WHAT IS THE PRODUCT CODE? LXMC13. WAS THE DEVICE INITIALLY EFFECTIVE IN CONTROLLING REFLUX? YES. WERE ANY EVENTS ASSOCIATED WITH THE ONSET OF SYMPTOMS (VOMITING, RETCHING, TRAUMA, SURGERY)? NO. DID THE PATIENT UNDERGO AN MRI SINCE DEVICE IMPLANT? IF SO, WHEN WAS THE MRI AND WHAT STRENGTH? NO. DID THE PATIENT HAVE ANY OTHER SURGERIES IN THE AREA? NO. 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. THE LAST IMAGING WE HAVE IS AN UPPER GI FROM 3/2018 AND THE DEVICE WAS INTACT. WHAT IS THE MANAGEMENT PLAN? EXPLANT ON (B)(6) 2021. IS DEVICE REMOVAL SCHEDULED? YES, IT HAPPENED ON (B)(6) 2021. IS A REPLACEMENT LINX OR FUNDOPLICATION PLANNED? NO, JUST REMOVAL OF THE LINX WAS PERFORMED. THE HIATUS WAS INTACT. WHEN AND IF THE EXPLANATION TAKES PLACE CAN WE ASK THAT THE PROCEDURE GETS VIDEO RECORDED AND THE VIDEO SHARED? NO, TOO LATE. IT HAPPENED YESTERDAY. WHEN AND IF THE LINX DEVICE IS REMOVED, MAY WE ASK THAT THE DEVICE BE RETURNED FOR ANALYSIS? YES, WE ARE WORKING WITH THE HOSPITAL TO RETURN THE DEVICE TO JNJ. WE ALREADY HAVE THE EXPLANT RETURN BOX.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LINX DEVICE WILL BE EXPLANTED DUE TO A VOLUNTARY RECALL. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228396 1.5T LINX, 13B ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LXMC13 14973 00855106005332

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention