BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 9097865 · Received September 20, 2019

    Report

    Report Number
    1644487-2019-01828
    Event Type
    Malfunction
    Date Received
    September 20, 2019
    Date of Event
    June 10, 2019
    Report Date
    September 20, 2019
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    UDI-DI
    05425025750429
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS FOUND THROUGH THE PERIODIC PROGRAMMING HISTORY DATABASE REVIEW THAT THERE WAS A FALSE HIGH IMPEDANCE FOUND WITH SOFTWARE VERSION 1.5. IT WAS VERIFIED THAT THE IMPEDANCE WAS FINE AT THE FOLLOWING CLINIC VISIT WHERE THE DEVICE WAS CHECKED BY SOFTWARE VERSION 1.0. IT WAS DETERMINED THAT THE CAUSE OF THIS FALSE HIGH IMPEDANCE MESSAGE WAS A SOFTWARE ERROR ON M3000 V1.5.2.1 SOFTWARE; WHEN SYSTEM DIAGNOSTICS WERE PERFORMED BY THE USER WITH M3000 V1.5.2.1 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 FURTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895051 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS - HOUSTON MODEL 3000 05425025750429

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR