BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1881284 · Received October 6, 2010

    Report

    Report Number
    1644487-2010-02239
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEUROLOGIST'S (B)(4) X5 HANDHELD COMPUTER WOULD FREEZE AT THE INTERROGATION SUCCESSFUL SCREEN. THE NEUROLOGIST INDICATED THAT THE HANDHELD BECOMES UNRESPONSIVE AFTER INTERROGATIONS AND TROUBLESHOOTING IS KNOWN TO RESOLVE THE ISSUE. THE NEUROLOGIST REQUESTED A NEW HANDHELD COMPUTER AND THE REPORTED HANDHELD WAS RETURNED TO THE MFR TO UNDERGO PRODUCT ANALYSIS. PRODUCT ANALYSIS WAS COMPLETED BY THE MFR. PRODUCT ANALYSIS OF THE RETURNED HANDHELD COMPUTER REVEALED NO ANOMALIES ASSOCIATED WITH THE HANDHELD WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE DEVICE PERFORMED ACCORDING TO FUNCTIONAL SPECS. MOREOVER, PRODUCT ANALYSIS OF THE RETURNED FLASHCARD REVEALED THE ALLEGED SCREEN FREEZE COMPLAINT IS A KNOWN ISSUE THAT HAS BEEN EVALUATED AND ADDRESSED BY THE MFR. NO FURTHER PA TESTING WAS REQUIRED FOR THIS PARTICULAR EVENT. NO OTHER ISSUES WERE OBSERVED WITH EITHER THE FLASHCARD OR SOFTWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 521406

    Patients

    Seq Age Sex Outcome Treatment
    1