BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3242382 · Received July 23, 2013

    Report

    Report Number
    1644487-2013-02219
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    DURING ANALYSIS OF THE HANDHELD DEVICE, IT WAS IDENTIFIED THAT THE TOUCHSCREEN DISPLAY WAS UNRESPONSIVE. THE CAUSE FOR THE DISPLAY ANOMALY IS ASSOCIATED WITH RESISTANCE VALUES BEING HIGHER THAN EXPECTED IN THE TOUCH SCREEN CIRCUITRY. ONCE THE DISPLAY WAS REPLACED WITH A KNOWN GOOD DISPLAY, NO FURTHER ANOMALIES ASSOCIATED WITH THE HANDHELD PERFORMANCE WERE IDENTIFIED DURING THE ANALYSIS. AN ANALYSIS WAS PERFORMED ON THE RETURNED FLASHCARD, AND NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT A PHYSICIAN¿S HANDHELD DEVICE (HHD) WAS FROZEN ON THE CALIBRATION SCREEN AFTER A HARD RESET. FOUR HARD RESETS WERE PERFORMED, AND EACH TIME THE SCREEN FROZE ON THE CALIBRATE SCREEN. THE SCREEN WAS CLEANED, BUT THE EVENT DID NOT RESOLVE. THE HHD WAS RETURNED ON (B)(4) 2013 AND IS PENDING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342804 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1073773

    Patients

    Seq Age Sex Outcome Treatment
    1