BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2902469 · Received January 8, 2013

    Report

    Report Number
    1644487-2013-00099
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    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

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS DELL X50 COMPUTER WAS NOT HOLDING A CHARGE. THE COMPUTER APPEARS AS IF IT IS CHARGING WHEN PLUGGED INTO THE CHARGER, BUT AS SOON AS IT IS REMOVED THE CHARGE DEPLETES. NO BATTERY SWELLING WAS NOTED, AND THE COMPUTER IS STORED IN A NORMAL OFFICE ENVIRONMENT. THE COMPUTER AND FLASHCARD HAVE BEEN RETURNED AND ARE PENDING ANALYSIS.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS WAS COMPLETED ON THE RETURNED COMPUTER AND FLASHCARD. NO ANOMALIES ASSOCIATED WITH THE HANDHELD COMPUTER 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 FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE ALSO PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9430 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS INC MODEL 250 1075834

    Patients

    Seq Age Sex Outcome Treatment
    1