BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2913023 · Received January 14, 2013

    Report

    Report Number
    1644487-2013-00139
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    A VNS TREATING NEUROLOGIST REPORTED THAT THE DELL X50 HANDHELD COMPUTER WAS NOT TURN ON. THE COMPANY REPRESENTATIVE FOLLOWED UP WITH THE NEUROLOGIST'S OFFICE AND PERFORMED TROUBLESHOOTING ON THE COMPUTER. THE DEVICE WAS ABLE TO BE TURNED ON AFTER PERFORMING A HARD RESET. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE PHYSICIAN. THE SPECIFIC PRODUCT INFORMATION IS UNKNOWN, AS THE PHYSICIAN HAS TWO DELL X50 HANDHELD COMPUTERS AND THE COMPUTER THAT COULD NOT BE TURNED ON WAS NOT SPECIFIED. HOWEVER, BOTH PROGRAMMING SYSTEMS WERE FUNCTIONING PROPERLY AFTER THE HARD RESET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20169 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS INC MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1