BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK LINX MAGNETIC IMPLANT

    MDR report key: 8817666 · Received July 23, 2019

    Report

    Report Number
    3008766073-2019-00397
    Event Type
    Injury
    Date Received
    July 23, 2019
    Report Date
    July 11, 2019
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PATIENT DEMOGRAPHICS RECEIVED: KEM (DOB 09/23/1948).

    Additional Manufacturer Narrative · 1

    (B)(4). ONLY EVENT DAY AND YEAR KNOWN: (B)(6) 2019. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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. WHAT IS THE PRODUCT CODE FOR THE LINX DEVICE? WHAT IS THE LOT NUMBER FOR THE LINX DEVICE? WHAT WAS THE IMPLANT DATE? WHAT WAS THE REASON FOR REMOVAL OF THE LINX DEVICE? DOES THE PATIENT HAVE ANY OF THE ALLERGIES TO METALS? IF SO, WHAT TEST HAVE BEEN DONE TO TEST FOR METAL ALLERGIES. IS THE PATIENT CURRENTLY TAKING CURRENTLY TAKING STEROIDS / IMMUNIZATION DRUGS? DID THE PATIENT HAVE ANY PRE-EXISTING DYSPHAGIA OR OTHER CONDITIONS (OTHER THAN GERD)? WAS THERE ANY HIATAL OR CRURAL REPAIR DONE AT THE SAME TIME AS THE IMPLANT? WAS MESH USED AT TIME OF IMPLANT? AT THE TIME OF REMOVAL, WAS THE DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY AT THE TIME OF REMOVAL? HAVE THE SYMPTOMS RESOLVED SINCE THE DEVICE WAS EXPLANTED?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER LINX IMPLANT PROCEDURE, THE PATIENT HAS HAD ISSUES WITH THE LINX RING AND WOULD LIKE IT EX-PLANTED. THE LINX RING WAS REMOVED ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609595 UNK LINX MAGNETIC IMPLANT ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1