BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 10560294 · Received September 21, 2020

    Report

    Report Number
    3008766073-2020-00146
    Event Type
    Injury
    Date Received
    September 21, 2020
    Report Date
    August 31, 2020
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4), DATE SENT: 10/27/2020. AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. A CONCLUSION COULD NOT BE REACHED AS TO WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: THE PATIENT WAS REFERRED TO MAYO CLINIC AND HAD THE DEVICE REMOVED. THE EXACT EXPLANT DATE IS UNKNOWN. THE PATIENT IS DOING WELL.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 9/21/2020. DATE OF EVENT: ONLY EVENT YEAR KNOWN: 2020. THE LOT WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED. ADDITIONAL INFORMATION WILL BE REQUESTED. IF A RESPONSE IS RECEIVED A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH LINX ABOUT 2 YEARS AGO. PATIENT RETURNED TO OFFICE WITH RECURRENT GERD SYMPTOMS. EGD SHOWED ERODED LINX. SURGEON WILL BE REFERRING THE PATIENT TO MAYO CLINIC FOR ENDOSCOPIC REMOVAL, DATE TO BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027681 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention