BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3092835 · Received May 3, 2013

    Report

    Report Number
    1644487-2013-01237
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PREVIOUSLY SUBMITTED REPORT INDICATED THAT THE DEVICE WAS RETURNED; HOWEVER, THE SOFTWARE FLASHCARD WAS RETURNED ON (B)(4) 2013. THE REPORT IS BEING SUBMITTED TO CORRECT THIS INFORMATION. PREVIOUSLY SUBMITTED MDR INDICATED AN INCORRECT MANUFACTURE DATE. THIS REPORT IS BEING SUBMITTED TO CORRECT THIS DATA.

    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

    ANALYSIS OF THE HANDHELD SHOWED THAT NO ANOMALIES ASSOCIATED WITH THE HANDHELD PERFORMANCE WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE SOFTWARE FLASHCARD WAS RETURNED ON (B)(6) 2013 AND IS PENDING ANALYSIS.

    Description of Event or Problem · 1

    ANALYSIS OF THE FLASHCARD WAS COMPLETED. 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

    REPORTER INDICATED A VNS DELL X50 COMPUTER WAS WORKING DURING INTERROGATION, BUT THEN WOULD FREEZE AND MAKE A BEEPING SOUND WHEN THE MENU BUTTON WAS PUSHED, AND THEN WOULD NO LONGER FUNCTION. THE SCREEN WOULD THEN FREEZE AFTER RESETTING THE COMPUTER. THE COMPUTER WORKS INTERMITTENTLY. THE COMPUTER WAS RETURNED AND IS PENDING ANALYSIS. THE FLASHCARD WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194135 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1