BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3010019 · Received March 18, 2013

    Report

    Report Number
    1644487-2013-00726
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    January 24, 2013
    Report Date
    February 19, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PRODUCT ANALYSIS OF THE COMPUTER AND FLASHCARD WAS COMPLETED. NO ANOMALIES ASSOCIATED WITH THE HANDHELD COMPUTER WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO SPECIFICATIONS. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    REPORTER INDICATED A DELL X5 COMPUTER WITH 8.0 SOFTWARE WAS FREEZING ON THE "INTERROGATION SUCCESSFUL" SCREEN FOR THE PREVIOUS 3 WEEKS. IT WAS NOT CLEAR HOW LONG THE SCREEN WAS FREEZING. THE COMPUTER AND FLASHCARD HAVE BEEN RETURNED AND ARE PENDING PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111937 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 839583

    Patients

    Seq Age Sex Outcome Treatment
    1