BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3955120 · Received July 24, 2014

    Report

    Report Number
    1644487-2014-01860
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    May 29, 2014
    Report Date
    July 1, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEUROLOGIST¿S HANDHELD DEVICE WAS WORKING SLOWLY. THE HANDHELD DEVICE WAS RETURNED FOR ANALYSIS. ANALYSIS IDENTIFIED THAT THE HANDHELD WAS UNABLE TO ADVANCE PAST THE SCREEN ALIGNMENT UTILITY. THE CAUSE FOR THE DISPLAY ANOMALY IS ASSOCIATED WITH RESISTANCE VALUES BEING HIGHER THAN EXPECTED IN THE TOUCH SCREEN CIRCUITRY. NO FURTHER ANOMALIES ASSOCIATED WITH THE HANDHELD PERFORMANCE WERE IDENTIFIED DURING THE ANALYSIS. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434029 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS INC MODEL 250 1063825

    Patients

    Seq Age Sex Outcome Treatment
    1