BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 9162699 · Received October 7, 2019

    Report

    Report Number
    1644487-2019-01948
    Event Type
    Malfunction
    Date Received
    October 7, 2019
    Date of Event
    January 25, 2019
    Report Date
    October 16, 2023
    Manufacturer
    LIVANOVA USA, INC.
    Product Code
    LYJ
    UDI-DI
    05425025750429
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING PRODUCT ANALYSIS OF THE GENERATOR AN ADDITIONAL INSTANCE OF A FALSE HIGH IMPEDANCE MESSAGE WAS OBSERVED FOR THE PATIENT'S DEVICE. NO ABNORMAL PERFORMANCE OR ANY OTHER TYPE OF ADVERSE CONDITION WAS FOUND WITH THE GENERATOR. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    IT WAS FOUND THROUGH PERIODIC PROGRAMMING HISTORY DATABASE REVIEW THAT THE PATIENT'S DEVICE SHOWED A FALSE HIGH IMPEDANCE READING WHEN SYSTEM DIAGNOSTICS WAS PERFORMED. IN THE FOLLOWING CLINIC VISIT THE PATIENT RETURNED AND DEVICE HAD SYSTEM DIAGNOSTICS PERFORMED SHOWING IMPEDANCE WAS WITHIN NORMAL LIMITS. IT WAS DETERMINED THAT THE CAUSE OF THIS FALSE HIGH IMPEDANCE MESSAGE WAS A SOFTWARE ERROR ON M3000 (B)(4) SOFTWARE; WHEN SYSTEM DIAGNOSTICS WERE PERFORMED BY THE USER WITH M3000 (B)(4) 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 ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956231 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ LIVANOVA USA, INC. 3000 05425025750429

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female