BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2062297 · Received April 12, 2011

    Report

    Report Number
    1644487-2011-00774
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    January 1, 2010
    Report Date
    March 16, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT A PHYSICIAN'S DELL X50 HANDHELD DEVICE WAS FREEZING ON THE INTERROGATION SCREEN. A HARD RESET WOULD RESOLVE THE ISSUE HOWEVER, THE PHYSICIAN WANTED THE HANDHELD REPLACED. THE PHYSICIAN WAS SENT A REPLACEMENT HANDHELD AND THE DELL X50 AND FLASHCARD WERE RETURNED TO THE MANUFACTURER FOR PRODUCT ANALYSIS. THERE WERE NO ANOMALIES FOUND WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. DURING THE ANALYSIS OF THE HANDHELD, IT WAS IDENTIFIED THAT THE DISPLAY HAD SOME DEAD PIXELS. THE DEAD PIXELS HAD NO FUNCTIONAL IMPACT ON THE HANDHELD PERFORMANCE AND WOULD NOT HAVE CONTRIBUTED TO THE ALLEGED "FROZEN SCREEN" CONDITION. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 537103

    Patients

    Seq Age Sex Outcome Treatment
    1