BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 8010781 · Received October 26, 2018

    Report

    Report Number
    1644487-2018-01936
    Event Type
    Malfunction
    Date Received
    October 26, 2018
    Date of Event
    October 1, 2018
    Report Date
    February 6, 2019
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750481
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT A DOSING APPOINTMENT FOR A PATIENT WITH A M102, THE DUTY CYCLE WAS FOUND TO BE AT 1% UPON ADVANCED INTERROGATION WITH M3000 V1.0 SOFTWARE. THE SESSION REPORT SHOWED THAT THE INITIAL AND FINAL INTERROGATION SETTINGS WERE AS EXPECTED. THE PATIENT'S SETTINGS WERE CORRECTED DURING THE SAME VISIT. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    THE GENERATOR'S PROGRAMMING HISTORY WAS REVIEWED. THERE WAS NO EVIDENCE OF A CHANGE IN DUTY CYCLE NOR A FAULTED DIAGNOSTICS DURING THE REPORTED EVENT. REVIEW OF THE INTERNAL TABLET DATA INDICATED NO OBVIOUS WARNING MESSAGE REGARDING THE DUTY CYCLE REPORTED. IT WAS DETERMINED THAT ALTHOUGH THE REPORT INDICATED THAT THE OBSERVED DUTY CYCLE HAPPENED AFTER INTERROGATION, IT WAS LIKELY THAT IT OCCURRED AFTER SYSTEM DIAGNOSTICS DUE TO THE ABSENCE OF ANY DATA SHOWING A 1% DUTY CYCLE. INSTEAD, THERE IS A KNOW DISPLAY ERROR THAT WOULD EXPLAIN WHY A 1% WOULD SHOW AFTER SYSTEM DIAGNOSTICS. ANY TIME SYSTEM DIAGNOSTICS IS PERFORMED IN-SESSION AND THE USER NAVIGATES BACK TO THE PARAMETERS SCREEN, ALL VALUES WILL DISPLAY CORRECTLY (INCLUDING ON TIME AND OFF TIME), EXCEPT FOR THE CALCULATED DUTY CYCLE, WHICH WILL SHOW 1%.. THIS DISPLAY OCCURS BECAUSE THE SYSTEM DIAGNOSTICS WILL PROGRAM THE GENERATOR TO THIS DUTY CYCLE TO RUN DIAGNOSTICS PRIOR TO PROGRAMMING THEM BACK TO THE INTENDED CYCLE. IN THESE CASES THE GENERATOR IS OPERATING AT INTENDED DUTY CYCLES SETTINGS AND REINTERROGATION WILL RESOLVE THE DISPLAY ERROR. NO FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848644 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ LIVANOVA USA, INC. MODEL 3000 05425025750481

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR