BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5T LINX, 15B

    MDR report key: 10297851 · Received July 20, 2020

    Report

    Report Number
    3008766073-2020-00100
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Date of Event
    January 24, 2020
    Report Date
    February 18, 2020
    Manufacturer
    TORAX MEDICAL, INC.
    Product Code
    LEI
    UDI-DI
    00855106005356
    PMA / PMN Number
    P100049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE. THE DHR FOR LOT 24717 WAS REVIEWED. NO NCS, DEFECTS, OR REWORKS RELATED TO THE PRODUCT COMPLAINT WERE FOUND. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WHAT TEST WAS PERFORMED TO SHOW THAT THE DEVICE WAS WORKING PROPERLY? BARIUM SWALLOW WITH BAGEL. DOES THE PATIENT BELIEVE THE TORAX LINX IS CAUSING THIS INTERFERENCE? THE TIME SHE WAS UNSURE. HOW IS THE LINX DEVICE ASSOCIATED WITH THE EVENT? IT IS UNCLEAR IF THE DEVICE ITSELF CAUSED THE N/V CHEST PAIN. IT MAY HAVE BEEN ATTRIBUTED TO ESOPHAGEAL SPASMS AFTER PLACEMENT WILL ADDITIONAL TESTING BE PERFORMED FOR THE PATIENT¿S ISSUES? NO. IS THIS MEDICATION PRESCRIBED BY THE DOCTOR (A PRESCRIPTION)? OR, IS THIS MEDICATION OVER THE COUNTER? THE MEDICATION WAS PRESCRIBED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHEST PAIN AND VOMITING (2 EPISODES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760831 1.5T LINX, 15B ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LXMC15 24717 00855106005356

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR