BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 8864177 · Received August 6, 2019

    Report

    Report Number
    1644487-2019-01515
    Event Type
    Malfunction
    Date Received
    August 6, 2019
    Date of Event
    March 4, 2019
    Report Date
    August 13, 2020
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750429
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WAS REFERRED FOR REPLACEMENT DUE TO UNKNOWN REASONS. A CALL WAS LATER RECEIVED FROM THE PHYSICIAN¿S OFFICE INFORMING THAT THE REASON FOR REPLACEMENT DUE TO THE PATIENT¿S HIGH LEAD IMPEDANCE THAT RESOLVED, WHICH THE PHYSICIAN UNDERSTOOD TO BE A RESULT OF BATTERY DEPLETION. THE CLINIC NOTES WERE FURTHER EVALUATED AND IT WAS DISCOVERED THAT THE PHYSICIAN INTERROGATED THE VNS WITH THE OUTPUT CURRENTS PROGRAMMED ON. THIS RESULTED IN "LEAD IMPEDANCE 6600-7700 OHMS.¿ THE PHYSICIAN THEN TURNED THE MAGNET AND THE OUTPUT TO 0MA AND RECHECKED THE DIAGNOSTICS. AT THIS TIME, THE LEAD IMPEDANCE WAS BACK TO NORMAL BETWEEN 4100-5200OHMS. THE PHYSICIAN NOTED THAT THE ONLY EXPLANATION TO THIS EVENT WAS LOW BATTERY WHICH NEEDS TO BE REPLACED. THE BATTERY STATUS OF THE GENERATOR WAS NOT PROVIDED WITHIN THE CLINIC NOTES. FURTHER FOLLOW UP CONFIRMED THAT THE SYSTEM DIAGNOSTICS TESTING WAS PERFORMED USING THE (B)(6) SOFTWARE. IT WAS DETERMINED THAT THE CAUSE OF THIS FALSE HIGH IMPEDANCE MESSAGE WAS A SOFTWARE ERROR ON (B)(6) SOFTWARE; WHEN SYSTEM DIAGNOSTICS WERE PERFORMED BY THE USER WITH (B)(6) SOFTWARE ON M102/102R GENERATORS (NORMAL MODE OUTPUT CURRENT >0 MA), NORMAL MODE DIAGNOSTICS WOULD ACTUALLY BE PERFORMED INSTEAD. THE EXECUTION OF NORMAL DIAGNOSTICS INSTEAD OF SYSTEM DIAGNOSTICS IS NOT APPARENT TO THE USER, AND THE RETURNED DCDC CODE WAS BEING COMPARED AGAINST SYSTEM DIAGNOSTIC THRESHOLDS. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658719 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ LIVANOVA USA, INC. 3000-V1.5 05425025750429

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR