BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 5054929 · Received September 3, 2015

    Report

    Report Number
    1644487-2015-05694
    Event Type
    Malfunction
    Date Received
    September 3, 2015
    Date of Event
    August 1, 2015
    Report Date
    August 7, 2015
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN'S HANDHELD FREEZES PERSISTENTLY ON THE INTERROGATION SCREEN. HARD RESETS HAVE BEEN PERFORMED WHICH HELPED ON SOME, BUT NOT ALL OCCURRENCES. THE PHYSICIAN WAS PROVIDED A NEW PROGRAMMING COMPUTER AND THE HANDHELD AND FLASHCARD WERE RECEIVED FOR ANALYSIS. ANALYSIS IS UNDERWAY, BUT HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS WAS COMPLETED FOR THE HANDHELD DEVICE. NO ANOMALIES ASSOCIATED WITH THE HANDHELD PERFORMANCE WERE NOTED DURING TESTING. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. PRODUCT ANALYSIS WAS COMPLETED FOR THE SOFTWARE FLASHCARD. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. DURING THE ANALYSIS IT WAS IDENTIFIED THAT THE FLASHCARD CONTAINED A MAC OSX OPERATING SYSTEM FILE AND FOLDERS. THE PRESENCE OF THE FILE AND FOLDERS IS AN INDICATION THAT THE FLASHCARD WAS INSERTED INTO A DEVICE USING THE MAS OSX OPERATING SYSTEM. THE FILE AND FOLDERS HAD NO IMPACT ON THE VNS SOFTWARE PERFORMANCE. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586443 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 1063825

    Patients

    Seq Age Sex Outcome Treatment
    1