BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1832144 · Received September 3, 2010

    Report

    Report Number
    1644487-2010-02027
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 5, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN'S VNS HANDHELD COMPUTER SCREEN WOULD NOT MOVE OFF THE HP SCREEN. TROUBLESHOOTING WAS PERFORMED, BUT THE PROBLEM PERSISTED. PRODUCT WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. UPON ANALYSIS, A BROKEN SOLDER CONNECTION BETWEEN THE PCB AND A SCREW MOUNT WAS IDENTIFIED NEAR THE MAIN BATTERY TERMINAL. THE BROKEN SOLDER CONNECTION CAN PREVENT THE MAIN BATTERY FROM MAKING GOOD ELECTRICAL CONTACT WITH THE PCB ALLOWING THE HANDHELD TO LOSE POWER MOMENTARILY. THE MOMENTARY LOSS IN POWER CAN CAUSE THE HANDHELD TO STALL ON THE HP BOOT UP SCREEN DUE TO FILE CORRUPTIONS ASSOCIATED WITH THE OPERATING SYSTEM. NO FURTHER ANOMALIES ASSOCIATED WITH THE HHD WERE IDENTIFIED DURING THE ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 521378

    Patients

    Seq Age Sex Outcome Treatment
    1