BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2081513 · Received April 19, 2011

    Report

    Report Number
    1644487-2011-00833
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    January 23, 2011
    Report Date
    March 23, 2011
    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

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NEUROLOGIST THAT HIS HANDHELD DEVICE KEPT FREEZING ON INTERROGATION SUCCESSFUL SCREEN WHICH SHE RESOLVED BY RESTING THE HANDHELD AND UNPLUGGING IT FROM THE WALL. THE PRODUCTS WERE RETURNED TO MANUFACTURER WHERE HANDHELD, FLASH CARD, AND WAND UNDERWENT PRODUCT ANALYSIS. ANALYSIS OF THE HANDHELD DID NOT DETECT ANY ANOMALIES DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS OF THE MANUFACTURER. AN ANALYSIS WAS ALSO PERFORMED ON THE FLASHCARD AND THE REPORTED ALLEGATION OF SCREEN FREEZE WAS NOT CONFIRMED. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. LASTLY, THE WAND WAS RETURNED FOR ANALYSIS. AFTER REPLACING THE DEPLETED BATTERY OF THE WAND, THE PROGRAMMING WAND PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. NO ANOMALY WAS IDENTIFIED, WHICH WOULD ADVERSELY IMPACT BATTERY LONGEVITY NOR ANY MECHANICAL OR VISUAL ANOMALY WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 283001

    Patients

    Seq Age Sex Outcome Treatment
    1