BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 4131294 · Received October 1, 2014

    Report

    Report Number
    1644487-2014-02523
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 31, 2014
    Report Date
    September 8, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 INITIALLY REPORTED THAT THE PHYSICIAN WAS HAVING ISSUES GETTING HIS HANDHELD DEVICE TO RESPOND ON (B)(6) 2014. A HARD RESET WAS PERFORMED WHICH RESOLVED THE ISSUES WITH THE HANDHELD THE SAME DAY. THE PHYSICIAN AGAIN EXPERIENCED DIFFICULTIES GETTING HIS HANDHELD TO RESPOND ON (B)(6) 2014. THE HANDHELD WAS ONLY RESPONDING TO BUTTON PRESSES AND NOT TO SCREEN PRESSES. THE HANDHELD SCREEN WAS CLEANED AND HARD RESETS WERE PERFORMED; HOWEVER, THE ISSUE DID NOT RESOLVE. THE LOCK BUTTON WAS CONFIRMED TO BE DISENGAGED. FOLLOW-UP REVEALED THAT THE HANDHELD WOULD NOT PAST THE ALIGNMENT SCREEN. THE HANDHELD DEVICE AND SOFTWARE FLASHCARD HAVE BEEN RETURNED TO THE MANUFACTURER WHERE ANALYSIS IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED HANDHELD DEVICE AND SOFTWARE FLASHCARD WAS COMPLETED. IT WAS VERIFIED 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
    611413 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1073773

    Patients

    Seq Age Sex Outcome Treatment
    1