BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3907287 · Received July 1, 2014

    Report

    Report Number
    1644487-2014-01652
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 6, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: SUPPLEMENTAL MDR #01 INADVERTENTLY INDICATED THAT THE REPORT WAS ALSO A CORRECTION REPORT. NO CORRECTIONS WERE REQUIRED. SUPPLEMENTAL MDR #01 INADVERTENTLY INDICATED THAT THE REPORT WAS ALSO A CORRECTION REPORT. NO CORRECTIONS WERE REQUIRED.

    Additional Manufacturer Narrative · 1

    NEW INFORMATION RECEIVED CORRECTS THE PATIENT'S AGE AT THE TIME OF THE EVENT AND THE EVENT DATE.

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE HANDHELD PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    ANALYSIS OF THE HANDHELD WAS COMPLETED ON (B)(4) 2014. 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. ANALYSIS OF THE FLASHCARD WAS COMPLETED ON (B)(4) 2014. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. DURING THE ANALYSIS IT WAS IDENTIFIED THAT THE FLASHCARD CONTAINED AN OS X FILE AND FOLDER. THE PRESENCE OF THE FILE AND FOLDER IS AN INDICATION THAT THE FLASHCARD WAS INSERTED INTO A DEVICE USING THE OS X OPERATING SYSTEM. THE PRESENCE OF THE FILE AND FOLDER HAS NO IMPACT ON THE VNS SOFTWARE PERFORMANCE. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEUROLOGIST¿S HANDHELD DEVICE HAD A BLACK SCREEN AND A HARD RESET COULD NOT BE PERFORMED. THE HANDHELD DEVICE HAS BEEN RETURNED TO THE MANUFACTURER WHERE ANALYSIS IS CURRENTLY UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384308 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1063525

    Patients

    Seq Age Sex Outcome Treatment
    1