BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 5205963 · Received November 5, 2015

    Report

    Report Number
    1644487-2015-06353
    Event Type
    Malfunction
    Date Received
    November 5, 2015
    Date of Event
    October 8, 2015
    Report Date
    October 8, 2015
    Manufacturer
    CYBERONICS - HOUSTON
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN'S PROGRAMMING TABLET WAS GIVING A MESSAGE "UNABLE TO BACKUP DATABASE TO EXTERNAL MEDIA. PLEASE CONTACT CYBERONICS FOR FURTHER ASSISTANCE." IT WAS IDENTIFIED THAT THIS MESSAGE IS RELATED TO A DEFECT V110-723 AND WILL OCCUR WHEN EXPORTING THE DATABASE. IT IS POSSIBLE THAT THE SD CARD WAS REMOVED OR THE SD CARD WAS WRITE PROTECTED. THE PHYSICIAN WAS PROVIDED A NEW PROGRAMMING TABLET UNTIL FURTHER TROUBLESHOOTING COULD BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734254 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS - HOUSTON MODEL 250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1