BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2232355 · Received September 2, 2011

    Report

    Report Number
    1644487-2011-02056
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 19, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6), 2011 WHEN THE PHYSICIAN'S HANDHELD AND FLASHCARD WERE RECEIVED BY THE MANUFACTURER FOR PRODUCT ANALYSIS. PRODUCT ANALYSIS ON THE FLASHCARD REVEALED NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. NO ANOMALIES ASSOCIATED WITH THE MAIN BATTERY OF THE HANDHELD WERE NOTED DURING TESTING. DURING ANALYSIS IT WAS IDENTIFIED THAT THE HANDHELD WOULD NOT POWER ON. THE CAUSE FOR THE ANOMALY WAS ASSOCIATED WITH DAMAGE TO THE MAIN BOARD AND DISPLAY FROM EXPOSURE TO AN UNKNOWN FLUID AND APPEARED TO BE A USER-RELATED EVENT AND NOT A DEVICE ANOMALY. NO FURTHER ANOMALIES WERE IDENTIFIED.

    Description of Event or Problem · 1

    ON (B)(6) 2011 A VNS TREATING PHYSICIAN REPORTED THAT HIS HANDHELD IS NO LONGER HOLDING A CHARGE. THE CONSULTANT CONFIRMED THAT IT WASN'T HOLDING A CHARGE AND THE HANDHELD IS STORED ON THE PHYSICIAN'S DESK. THE CONSULTANT REPORTED THAT THE HANDHELD WOULD BE RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS, BUT IT HAS NOT YET BEEN RECEIVED. WHEN ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SYSTEM LYJ CYBERONICS, INC. MODEL 250 67830

    Patients

    Seq Age Sex Outcome Treatment
    1