BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5T LINX, 13B

    MDR report key: 12609270 · Received October 11, 2021

    Report

    Report Number
    3008766073-2021-00202
    Event Type
    Injury
    Date Received
    October 11, 2021
    Date of Event
    January 1, 2021
    Report Date
    January 31, 2022
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    UDI-DI
    00855106005332
    PMA / PMN Number
    P100049
    Removal / Correction Number
    Z-2038-2018
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 12/14/2021. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WAS THE DEVICE EXPLANTED ON (B)(6) 2021? WHEN DID THE SYMPTOMS BEGIN? WHAT WAS THE DATE OF THE IMAGING WHICH SHOWED THE DISCONTINUOUS LINX? IF AVAILABLE, PLEASE SHARE A COPY OF THIS IMAGING. 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? ANSWERS = IT WAS REPORTED BY THE SALES REP THAT A LINX DEVICE WAS EXPLANTED DUE TO A DISCONTINUOUS DEVICE. DEVICE POPPED APART BUT NOT AT THE CLASP. DISCONTINUOUS DEVICE WAS FOUND DURING A ROUTINE EGD SCOPE. A NEW DEVICE WAS IMPLANTED. DEVICE EXPLANTED ON DATE OF EXPLANT (B)(6) 2021. LOT NUMBER AND MODEL OF THE DEVICE (MODEL WOULD BE LXC## OR LXMC##) 11150, LXMC13. DID DR. (B)(6) REPLACE THE LINX DEVICE? NOT YET. IMPLANT DATE ORIGINAL SURGERY (B)(6) 2017. REPLACEMENT DATE NOT SCHDULED YET. ANY MRI SINCE IMPLANTATION? IF SO, WHEN AND MRI STRENGTH NO. ANY TRAUMA THAT MAY HAVE IMPACTED THE DEVICE AND CAUSED IT TO SEPARATE? NO. HOW DID THE PATIENT PRESENT¿WAS THERE AN ISSUE THAT PROMPTED THE PATIENT TO COME IN (EG REFLUX BACK) OR AN INCIDENTAL X-RAY THAT IDENTIFIED THE DISCONTINUITY? SEEN IN CLINIC WITH REFLUX. ASSUMING THERE WAS A CHEST X-RAY, COULD YOU SHARE THE IMAGE? NA.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 11/4/2021. INVESTIGATION SUMMARY: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AS PART OF ETHICON'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER 11150, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. LOT 11150 WAS AN AFFECTED LOT OF THE 2018 LINX RECALL.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 1/31/2022 . INVESTIGATION SUMMARY: THE VISUAL ANALYSIS FOUND THAT THE RETURNED DEVICE HAD AN EXPOSED WELL BALL PAIRED WITH THE WASHER TROUGH HOLE OF THE ADJACENT BEAD. THE AFFECTED WASHER THROUGH HOLE DIAMETER WAS MEASURED WITH COMPUTED TOMOGRAPHY (CT) AND WAS FOUND TO BE GREATER THAN THE SPECIFICATION. THE WASHER THROUGH HOLE SHOWED AN ENLARGED THROUGH HOLE AT THE FAILED LINK. THE OVERALL APPEARANCE OF THE SURFACE OF THE WASHER DIDN'T EXHIBIT LOSS OF SHAPE. TOP VIEW OF THE DIAMETER OF THE EXPOSED WELD BALL WAS MEASURED. THIS DIAMETER IS WITHIN THE SPECIFICATION. THE WELD BALL APPEARS TO BE SPHERICAL AND CONCENTRIC WITH RESPECT TO THE WIRE. THE PAIRED WELD BALL WAS FOUND TO BE WITHIN SPECIFICATION. A SMALL INTERFERENCE WAS FOUND BETWEEN THE DIAMETERS OF THE OUT OF SPECIFICATION WASHER THROUGH HOLE AND THE CORRESPONDING EXPOSED WELD BALL. IT IS PRESUMED THAT A CERTAIN GEOMETRIC COMBINATION OF THE WELD BALL AND THE WASHER THROUGH HOLE RESULTED IN THE DEVICE SEPARATION IN VIVO. THE LINK LENGTH AND TENSILE FORCE WERE FOUND TO MEET THE APPLICABLE SPECIFICATIONS. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 12/27/2021.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: ONLY EVENT YEAR KNOWN: 2021. 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: WHEN DID THE SYMPTOMS BEGIN? WHAT WAS THE DATE OF THE IMAGING WHICH SHOWED THE DISCONTINUOUS LINX? IF AVAILABLE, PLEASE SHARE A COPY OF THIS IMAGING. 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? ANSWER = EXPLANT TO TAKE PLACE ON (B)(6) 2021. UNKNOWN TO ALL ANSWERS UNTIL THAT TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS HAVING REFLUX ISSUES SO THE PATIENTS DOCTOR ORDERED AN EGD. THEY FOUND THAT THE DEVICE WAS DISCONTINUOUS. THE PATIENT WILL HAVE THE DEVICE EXPLANTED BUT NO DATE HAS BEEN SCHEDULED. THE DEVICE WAS INITIALLY IMPLANTED ON (B)(6) 2017. THERE IS NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1505603 1.5T LINX, 13B ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LXMC13 11150 00855106005332

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention