BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2181387 · Received July 1, 2011

    Report

    Report Number
    1644487-2011-01484
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6), 2011, A VNS TREATING PHYSICIAN REPORTED THAT HE WAS HAVING PROBLEMS WITH HIS HANDHELD HOLDING A CHARGE. THE CONSULTANT REPLACED THE CORD IN AN EFFORT TO TROUBLESHOOT. THE POWER LIGHT WAS GREEN WHILE CHARGING AND IT WAS CONFIRMED THAT IT WAS ACTUALLY CHARGING ON THE USER PREFERENCES SCREEN. HOWEVER, WHEN THE HANDHELD WAS UNPLUGGED FROM THE WALL, THE BATTERY DECREASED ABOUT 10% AFTER ABOUT A MINUTE. GOOD FAITH ATTEMPTS FOR PRODUCT RETURN HAVE BEEN MADE BUT THE PRODUCT HAS NOT YET BEEN RETURNED FOR PRODUCT ANALYSIS. IF ADDITIONAL INFO IS RECEIVED, IT WILL BE REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE MANUFACTURER'S CONSULTANT REPORTED THAT SHE VISITED THE PHYSICIAN'S OFFICE AND FOUND OUT THAT THEY STILL HAVE NOT SENT THE PROGRAMMING SYSTEM TO THE MANUFACTURER FOR PRODUCT ANALYSIS. SHE STATED THAT SHE NOW HAS THE PROGRAMMING SYSTEM AND WILL BE SENDING IT TO THE MANUFACTURER; HOWEVER IT HAS NOT YET BEEN RECEIVED. WHEN ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2011, WHEN THE PHYSICIAN'S HANDHELD AND FLASHCARD WERE RECEIVED FOR PRODUCT ANALYSIS. PRODUCT ANALYSIS WAS COMPLETED ON (B)(6) 2011, WHICH REVEALED NO ANOMALIES ASSOCIATED WITH THE FLASHCARD SOFTWARE OR DATABASE. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. AN ANALYSIS WAS PERFORMED ON THE HANDHELD AND THE REPORTED ALLEGATION THAT THE HANDHELD WOULD NOT HOLD A CHARGE WAS NOT VERIFIED. NO ANOMALIES ASSOCIATED WITH THE HANDHELD WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS AND THE REMAINING BATTERY CHARGE LEVEL AFTER OVER AN HOUR OF TESTING WAS 58% OF FULL CAPACITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 885473

    Patients

    Seq Age Sex Outcome Treatment
    1