BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 9611333 · Received January 21, 2020

    Report

    Report Number
    3008766073-2020-00015
    Event Type
    Injury
    Date Received
    January 21, 2020
    Date of Event
    December 9, 2019
    Report Date
    January 6, 2020
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 09/23/2020. ADDITIONAL INFORMATION RECEIVED: THE PATIENT UNDERWENT A LAPAROSCOPIC NISSEN FUNDOPLICATION AS THE SURGEON WAS CONCERNED ABOUT SCAR TISSUE AT THE TIME OF DEVICE REMOVAL. HE HAD MORE DIFFICULTY INITIALLY FOLLOWING THIS PROCEDURE BUT NOW THE GERD SYMPTOMS HAVE RESOLVED.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 03/31/2020. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS EVALUATION COULD NOT BE PERFORMED. ADDITIONAL INFORMATION RECEIVED: DEVICE WAS REMOVED ON (B)(6) 2019. DEVICE WAS DISCARDED BY THE HOSPITAL.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 05/28/2020. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS RECEIVED: WHAT WAS THE CONDITION OF THE DEVICE WHEN IT WAS REMOVED? WAS THERE ANYTHING UNUSUAL NOTED? RESPONSE: I SPOKE WITH THE SURGEON ON 5.12.20 AND HE SAID THERE WAS NOTHING UNUSUAL ABOUT THE DEVICE¿S CONDITION UPON REMOVAL OTHER THAN THE DISCONTINUOUS NATURE WHICH WAS ALREADY KNOWN AND THE PRIMARY REASON THE DEVICE WAS EXPLANTED. THERE WAS NOTHING ELSE UNUSUAL TO REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). MAUDE REPORT # MW5091745. THE LOT WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED, "IN (B)(6) OF 2016 A LINX DEVICE MANUFACTURED BY TORAX MEDICAL WAS IMPLANTED TO TREAT GERD AT (B)(6) AND WHILE IN (B)(6), AFTER OTHER ATTEMPTS TO TREAT GERD SUCH AS PPI'S HAD FAILED. WHILE WORKING IN (B)(6) IN (B)(6) OF 2019, I NOTICED MY GERD SYMPTOMS HAD RETURNED. ON (B)(6), I RECEIVED A POSITIVE DIAGNOSIS THROUGH A TEST AT UNIVERSITY OF (B)(6) AT (B)(6) THAT THE LINX HAD FAILED AND INFO THAT MY DEVICE WAS PART OF A RECALL. TORAX MEDICAL HAD AGREED TO PAY FOR A REPLACEMENT DEVICE BUT NOT THE SURGERY OR OTHER COSTS ASSOCIATED WITH THE OPERATION. BECAUSE OF THIS, I POSTPONED THE SURGERY FOR SEVERAL MONTHS AND ATTEMPTED TO MANAGE MY GERD SYMPTOMS WITH MODIFICATIONS TO MY DIET AND PPI'S. ON (B)(6), 2019 I SCHEDULED THE SURGERY TO HAVE THE LINX REMOVED AND HAVE A FUNDOPLICATION AT THE UNIVERSITY OF (B)(6) HEALTH CENTER IN (B)(6). AT THIS TIME, MY INSURANCE COMPANY IS DENYING PAYING FOR THE SURGERY. TORAX MEDICAL IS ALSO DENYING PAYING FOR THE SURGERY. WHEN THE LINX DEVICE WAS REMOVED. IT WAS EXAMINED BY THE DR AND HE COMMENTED THE DEVICE HAD DETERIORATED SIMILAR TO A CHEAP PIECE OF JEWELRY AND WAS BROKEN. THIS INDICATED INFERIOR QUALITY OF MATERIAL AND POOR MFG OVERSIGHT IN THE CONSTRUCTION OF THE LINX, WHICH RESULTED IN PREMATURE FAILURE. EVEN THOUGH THE DEVICE IS UNDER RECALL. TORAX MEDICAL DOES NOT APPEAR TO BE RESPONSIBLE FOR ANYTHING OTHER THAN A REPLACEMENT DEVICE. THIS DOES NOT SEEM MORALLY OR ETHICALLY RIGHT FOR A COMPANY TO BE ALLOWED TO TAKE THIS APPROACH. ALSO, I AM FACED WITH WHO WILL PAY FOR THE DEVICE REMOVAL, AND FUNDOPLICATION SURGERY, SINCE MY INSURANCE COMPANY AND TORAX MEDICAL ARE CURRENTLY IN DENIAL TO PAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74653 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1