BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LS14

    MDR report key: 10258327 · Received July 10, 2020

    Report

    Report Number
    3008766073-2020-00095
    Event Type
    Injury
    Date Received
    July 10, 2020
    Date of Event
    June 1, 2020
    Report Date
    June 17, 2020
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    UDI-DI
    00855106005035
    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: 08/12/2020. ADDITIONAL INFORMATION WAS RECEIVED: SHE HAS NOT MADE A DECISION. SHE KNOWS OF YOUR OFFER TO GIVE HER A NEW DEVICE. SHE HAS SOME OTHER SIGNIFICANT HEALTH ISSUES NOW AND IS UNCERTAIN ABOUT GOING THROUGH ANOTHER PROCEDURE.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 07/31/2020.

    Additional Manufacturer Narrative · 1

    (B)(4). UNKNOWN, ASSUMED THE 1ST DAY OF MONTH THE COMPLAINT WAS REPORTED. THE DHR FOR LOT 1819 WAS REVIEWED. NO NCS, DEFECTS, OR REWORKS RELATED TO THE PRODUCT COMPLAINT WERE FOUND. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS RECEIVED: BESIDES GERD¿S WERE THERE ANY OTHER SYMPTOMS LEADING TO THE DISCOVERY OF THE DISCONTINUOUS DEVICE? WHEN DID THEY BEGIN (INCLUDING GERD¿S)? PATIENT IS RECENTLY UNDERGOING CHEMOTHERAPY FOR MULTIPLE MYELOMA WHICH HAS MADE HER ILL. SHE NOTED A RETURN OF GERD SYMPTOMS AFTER A BOUT OF RETCHING, RETURNED TO THE OFFICE ON (B)(6) 2020 WAS THE DEVICE INITIALLY EFFECTIVE IN CONTROLLING REFLUX? YES, THE PATIENT HAD BEEN DOING WELL. WERE ANY EVENTS ASSOCIATED WITH THE ONSET OF SYMPTOMS (VOMITING, RETCHING, TRAUMA, SURGERY)? CHEMO DID THE PATIENT UNDERGO AN MRI SINCE DEVICE IMPLANT? NO, THIS DEVICE IS NOT MRI COMPATIBLE. DID THE PATIENT HAVE ANY OTHER SURGERIES IN THE AREA? NO DOES THE DEVICE APPEAR TO BE IN A CONTINUOUS ANNULAR STATE IN THESE IMAGES? NO, ON THE BARIUM SWALLOW, THE DEVICE APPEARS TO BE DISCONTINUOUS. WHAT IS THE MANAGEMENT PLAN? THE SURGEON WAS GOING TO DISCUSS THE OPTIONS WITH THE PATIENT. NOT AWARE OF A DEFINITIVE PLAN WHEN I LAST SPOKE WITH THE SURGEON. IS DEVICE REMOVAL SCHEDULED? NO, NOT YET. IS A REPLACEMENT LINX OR FUNDOPLICATION PLANNED? UNSURE ETHICON MEDICAL REVIEW: I REVIEWED SOME ENDOSCOPY IMAGES WHICH SHOWED A SMALL HILL TYPE II GEJ ON RETROFLEXION WITH A NORMAL LOOKING ANTRUM, PYLORUS AND DUODENUM. THERE WERE ALSO 3 FLUOROSCOPIC IMAGES OF THE GEJ TAKEN DURING THE ENDOSCOPY PROCEDURE WHICH SHOWED A C-SHAPED LINX DEVICE AT THE GEJ WITH A DISTENDED STOMACH. A BRAVO CAPSULE WAS PRESENT IN THE FIRST IMAGE AND THE ENDOSCOPE IN THE ESOPHAGUS IN THE OTHER TWO IMAGES. THE FLUOROSCOPIC IMAGES WERE CONSISTENT WITH A DISCONTINUOUS LINX DEVICE GIVEN THE C-SHAPE AND WIDE GAP BETWEEN BEADS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FIELD AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A RETURN OF GERD AFTER HAVING THE LINX DEVICE IMPLANTED ON (B)(6) 2009. AN XRAY WAS TAKEN AND IT WAS DISCOVERED THAT THE LINX DEVICE WAS DISCONTINUOUS AND IN A C SHAPE. IT HAS NOT BEEN DETERMINED IF THE PATIENT WILL HAVE THE DEVICE REMOVED DUE TO THE PATIENT BEING DIAGNOSED WITH CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724914 LS14 ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LS-[14] 1819 00855106005035

    Patients

    Seq Age Sex Outcome Treatment
    1