BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2100658 · Received May 12, 2011

    Report

    Report Number
    1644487-2011-01070
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    March 14, 2011
    Report Date
    April 28, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PHYSICIAN'S HANDHELD WAS PERFORMING SLOWLY. THE HANDHELD AND FLASHCARD WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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. DURING THE ANALYSIS, IT WAS IDENTIFIED THAT THE CYBERONICS.CDB DATABASE WAS INCOMPLETE/CORRUPT CAUSING THE HANDHELD TO DISPLAY SQL ERRORS WHEN AN INTERROGATION WAS PERFORMED. THE MOST LIKELY CAUSE FOR THE DATABASE ANOMALY IS ASSOCIATED WITH THE 8.0 UPGRADE BEING INTERRUPTED WHILE IT WAS CREATING THE CYBERONICS.CDB DATABASE. NO FURTHER ANOMALIES WERE IDENTIFIED DURING THE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 840143

    Patients

    Seq Age Sex Outcome Treatment
    1