BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.5T LINX, 15B

    MDR report key: 10199986 · Received June 26, 2020

    Report

    Report Number
    3008766073-2020-00093
    Event Type
    Malfunction
    Date Received
    June 26, 2020
    Date of Event
    February 11, 2020
    Report Date
    February 11, 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 · 0

    (B)(4), DATE SENT: 3/22/2021. ADDITIONAL INFORMATION RECEIVED: DATE OF RESOLUTION: 29 DEC 2020 RESOLUTION OF CANDIDAL ESOPHAGITIS.

    Additional Manufacturer Narrative · 0

    (B)(4), DATE SENT: 2/11/2021. ADDITIONAL INFORMATION RECEIVED: THE PATIENT WAS PRESCRIBED DIFLUCAN-200 MG. PO, QD, (B)(6) 2020 THROUGH (B)(6) 2020. PATHOLOGY CONFIRMED CANDIDAL ESOPHAGITIS.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 01/08/2021. ADDITIONAL INFORMATION RECEIVED: PRESUMED CANDIDAL ESOPHAGITIS DISCOVERED DURING EGD. PT. REPORTED NO SYMPTOMS. PT. WAS RECENTLY ON A COURSE OF ANTIBIOTICS WHICH MAY BE THE CAUSE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DHR FOR LOT 23772 WAS REVIEWED. NO NCS, DEFECTS, OR REWORKS RELATED TO THE PRODUCT COMPLAINT WERE FOUND 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

    THE FOLLOWING WAS REPORTED THAT THE PATIENT HAD ONGOING DIARRHEA. START DATE: (B)(6) 2020 (NEW ONSET 21 DAYS AFTER THE LINX IMPLANT). IT MAY BE RELATED TO IRRITATION OF THE VAGUS NERVE STIMULATING THE GASTROCOLIC REFLEX OR IT COULD BE RELATED TO STOPPING HIGH DOSE PPIS, WHICH THIS PATIENT WAS ON FOR 20 YEARS. THE PATIENT IS EXPERIENCING DYSPHAGIA AFTER EATING. THE PATIENT HAS NOT BEEN EATING AS MUCH DUE TO THE DIARRHEA. THE DIARRHEA HAS IMPROVED SO PATIENT IS EATING MORE AND EXPERIENCING INTERMITTENT DYSPHAGIA. PATIENT WILL START EATING SMALL AMOUNTS EVERY TWO HOURS. MEDROL DOSE PACK STARTED. THERE ARE NO PLANS TO EXPLANT THE DEVICE. THE PATIENT IS VERY PLEASED WITH HER RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665579 1.5T LINX, 15B ANTI-REFLUX IMPLANT LEI TORAX MEDICAL, INC. LXMC15 23772 00855106005356

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR