BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 9097720 · Received September 20, 2019

    Report

    Report Number
    3008766073-2019-00465
    Event Type
    Injury
    Date Received
    September 20, 2019
    Report Date
    August 27, 2019
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    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). DATE SENT: 09/26/2019. H10: CORRECTED DATA: PATIENT CODES SCLERODERMA AND OBSTRUCTION FILED IN ERROR. THEY HAVE BEEN REMOVED.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 09/20/2019. DATE OF EVENT: UNKNOWN. THE LOT WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    TITLE: ROBOTIC ASSISTED REMOVAL OF MAGNETIC ESOPHAGEAL SPHINCTER WITH FUNDOPLICATION AUTHORS: MEARA M.P., ALEXANDER C., RODMAN C., RENTON D.B., SCHWARTZ J CITATION: SURG ENDOSC (2018); 32:S50¿S66. DOI: HTTP://DX.DOI.ORG/10.1007/S00464-018-6120-5. MAGNETIC ESOPHAGEAL SPHINCTER AUGMENTATION IS A RELATIVELY NEW TECHNIQUE FOR MANAGEMENT FOR REFLUX BEYOND TRADITIONAL MEDICATIONS. THE LONG-TERM OUTCOMES OF THIS DEVICE AND CONCERNS FOR POTENTIAL FAILURE OR EROSION REMAIN A PARAMOUNT ISSUE AS THE DEVICE IS APPLIED TO AN INCREASING NUMBER OF INDIVIDUALS, BOTH IN THE UNITED STATES AND WORLDWIDE. THIS CASE INVOLVES A (B)(6)-YEAR-OLD FEMALE PATIENT WITH A PAST SURGICAL HISTORY SIGNIFICANT FOR LINX DEVICE (ETHICON) IMPLANTATION IN 2013. THE PATIENT NOTED THAT SINCE THE SURGERY, SHE HAD NO RELIEF OF THE REFLUX AND THAT IN FACT, THE REFLUX HAD WORSENED TO A POINT WHERE THE SYMPTOMS WERE LIFESTYLE LIMITING. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT. A STANDARD NISSEN FUNDOPLICATION WAS PERFORMED WITH MINIMAL IMPACT ON THE PROCEDURE FROM THE PREVIOUSLY REMOVED DEVICE. IN CONCLUSION, ROBOTIC ASSISTED REMOVAL OF MAGNETIC ESOPHAGEAL SPHINCTER WITH FUNDOPLICATION CAN BE COMPLETED SAFELY AND EFFECTIVELY. ROBOTIC REMOVAL AND REPEAT FUNDOPLICATION CAN BE CONSIDERED IN PATIENT'S WHOSE DEVICE HAS SUBSEQUENTLY FAILED AND REMOVAL IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891070 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown