BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5T LINX, 14B

    MDR report key: 8780458 · Received July 11, 2019

    Report

    Report Number
    3008766073-2019-00385
    Event Type
    Injury
    Date Received
    July 11, 2019
    Date of Event
    June 24, 2019
    Report Date
    June 24, 2019
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    UDI-DI
    00855106005349
    PMA / PMN Number
    P100049
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS RECEIVED: IT WAS REPORTED THAT THE IMPLANT DATE WAS (B)(6). WHAT YEAR DID THE IMPLANT TAKE PLACE? 2019. WHAT IS THE PRODUCT CODE FOR THE LINX DEVICE THAT WAS REMOVED? LXMC14. WHAT IS THE LOT NUMBER OF THE LINX DEVICE? DON'T KNOW. WHAT IS THE ACCOUNT NUMBER/HOSPITAL NAME AND ADDRESS FOR THE WHERE THE EXPLANT TOOK PLACE? (B)(6) HOSPITAL; IMPLANT WAS PLACED AT (B)(6) CENTER. DID THE PATIENT HAVE AN AUTOIMMUNE DISEASE? KNOWN COMORBID CONDITIONS ARE LISTED ABOVE. IS THE PATIENT CURRENTLY TAKING STEROIDS / IMMUNIZATION DRUGS? UNKNOWN. DID THE PATIENT HAVE ANY PRE-EXISTING DYSPHAGIA OR OTHER CONDITIONS (OTHER THAN GERD)? KNOWN COMORBID CONDITIONS ARE LISTED ABOVE. HOW SEVERE WAS THE DYSPHAGIA/ODYNOPHAGIA BEFORE INTERVENTION? WERE THERE ANY INTRA-OPERATIVE COMPLICATIONS DURING IMPLANT? NO. IT WAS REPORTED THAT THE PATIENT HAD A PEH. WAS THIS REPAIRED AT IMPLANT? YES. WAS A CRURAL REPAIR DONE AT THE SAME TIME AS THE IMPLANT? YES SEE ABOVE. WERE THERE ANY OTHER CONTRIBUTING FACTORS THAT LED TO THE REMOVAL OF THE DEVICE OTHER THAN THE REPORTED DYSPHAGIA AND INTOLERANCE? UNKNOWN. WAS THE DEVICE FOUND IN THE CORRECT POSITION/GEOMETRY AT THE TIME OF REMOVAL? YES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST OP OF A LINX REMOVAL, DEVICE PLACED (B)(6); REMOVED (B)(6) DUE TO PERSISTENT DYSPHAGIA AND INTOLERANCE; NKA; ORIGINAL PROCEDURE WITH PEH WITH MESH. PATIENT HISTORY OF DVT, ANEMIA, ANXIETY, RIGHT BREAST CANCER WITH CHEMO, TAH, DVT, THE PATIENT WAS NOT PART OF A CLINICAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576216 1.5T LINX, 14B ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. 00855106005349

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR