BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2993466 · Received March 7, 2013

    Report

    Report Number
    1644487-2013-00620
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN'S HANDHELD PROGRAMMING SOFTWARE WAS NOT VISIBLE ON THE HANDHELD. THE PHYSICIAN REPORTED THAT THE SCREEN WOULD ONLY SHOW THE OPERATING SYSTEM LOADED ON THE HANDHELD RATHER THAN THE PROGRAMMING SYSTEM. THE PHYSICIAN ATTEMPTED TROUBLESHOOTING WHICH DID NOT CORRECT THE ISSUE. THE HANDHELD AND FLASHCARD WERE RETURNED TO DEVICE MANUFACTURER FOR ANALYSIS ON (B)(6) 2013. THE PRODUCT ANALYSIS ON THE HANDHELD AND FLASHCARD ARE CURRENTLY UNDERWAY AND HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    ANALYSIS OF THE HANDHELD DID NOT IDENTIFY ANY ANOMALIES DURING TESTINGS. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. THE FLASHCARD WAS ALSO ANALYZED. ANALYSIS OF THE FLASHCARD DID NOT IDENTIFY ANY ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97005 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 874814

    Patients

    Seq Age Sex Outcome Treatment
    1