BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINX MAGNETIC SPHINCTER

    MDR report key: 5843014 · Received July 29, 2016

    Report

    Report Number
    MW5063803
    Event Type
    Malfunction
    Date Received
    July 29, 2016
    Date of Event
    July 28, 2016
    Report Date
    July 29, 2016
    Manufacturer
    TORAX MEDICAL
    Product Code
    LEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ID, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    LINX MAGNETIC SPHINCTER IMPLANT PROBLEM. HIGH RESOLUTION MOTILITY STUDY RESULTS: ON 5 OUT OF 10 WET SWALLOWS, THE PT (ME) HAD NO PERISTALSIS, ON THE OTHER 5 HE HAD NORMAL PERISTALTIC WAVEFORM WITH SLIGHTLY LOW PRESSURES IN 30 TO 35 MMHG. DOCTOR'S IMPRESSION: PERISTALSIS ON 50% OF SWALLOWS WITH LOW AMPLITUDE. OTHERWISE PRIMARY NONCONDUCTION OF SWALLOWS. THE PT HAS A NON-SPECIFIC MOTILITY DISORDER. LINX WILL PREVENT REFLUX IN MANY, BUT IT CAN HAVE A HUGE EFFECT ON PEOPLE'S MOTILITY IN ORDER TO DO THAT - LIKE ME. DR. (B)(6), MY SURGEON IS INTERESTED IN NEW, IMPORTANT PRODUCTS LIKE THIS AND IS TO BE COMMENDED FOR HIS EFFORTS, BUT THE PRODUCT HAS ISSUES. WE PTS SHOULD BE MADE FULLY AWARE OF POSSIBLE MOTILITY PROBLEMS WHICH COULD BE SERIOUS AND REQUIRE EXPLANT YEARS AFTER IMPLANT. TORAX MEDICAL DOES NOT HAVE ANY INFO, TESTING DONE, OR LONG TERM MOTILITY TESTING INFO AVAILABLE TO PTS (OR DOCTORS?) FOR CONDITIONS LIKE MINE, PERISTALSIS, 50% MOTILITY SWALLOW WITH LOW AMPLITUDE. A SERIOUS COMPLICATION THAT COULD NECESSITATE REMOVAL. I WANT TO KNOW WHAT MOTILITY SCORES ARE FOR ALL LINX PTS ESPECIALLY LONG TERM PTS 2-3 YEARS OUT OR MORE. SERIOUS LACK OF MOTILITY MANOMETRY BRAVO PH TESTING AND SUBSEQUENT COMPLICATIONS OVER TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485552 LINX MAGNETIC SPHINCTER LINX MAGNETIC SPHINCTER LEI TORAX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other