BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2840444 · Received November 20, 2012

    Report

    Report Number
    1644487-2012-03082
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT WHILE ATTEMPTING TO UPGRADE THE PHYSICIAN'S HANDHELD THAT AN ERROR MESSAGE(S) WERE RECEIVED WHILE ATTEMPTING TO UPGRADE THE HANDHELD TO A NEW SOFTWARE VERSION. IT IS UNCLEAR WHAT THE SPECIFIC ERROR MESSAGE WAS THAT WAS RECEIVED. THE HANDHELD, BOTH THE OLD (V8.0) AND NEW (V8.1) SOFTWARE VERSION FLASHCARDS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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. 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 CAUSE FOR THE REPORTED COMPLAINT IS ASSOCIATED WITH A MISSING VNS81 FOLDER. THE CAUSE FOR THE MISSING FOLDER IS UNKNOWN, BUT THE MISSING CYBERONICS80 AND CYBERONICSBU FILES ON THE FLASHCARD AND THE MISSING FOLDER IN THE HANDHELD SUGGEST IT IS MOST LIKELY ASSOCIATED WITH AN INCOMPLETE V8.1 UPGRADE. NO OTHER ANOMALIES WERE IDENTIFIED. GOOD FAITH ATTEMPT FOR MORE INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS MODEL 250 845633

    Patients

    Seq Age Sex Outcome Treatment
    1