BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3813069 · Received May 15, 2014

    Report

    Report Number
    1644487-2014-01271
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS HAVING ISSUES WITH HIS PROGRAMMING TABLET. IT WAS REPORTED THAT WHEN THE TABLET IS ATTEMPTED TO BE USED AT THE INTERROGATION SCREEN, IT GIVE THE MESSAGE CANNOT FIND PORT. TROUBLESHOOTING WAS PERFORMED WHICH CONFIRMED THAT THE PROGRAMMING WAND WAS FUNCTIONING PROPERLY. A HARD RESET OF THE TABLET DID NOT RESOLVE THE ISSUE. A NEW PROGRAMMING TABLET WAS PROVIDED TO THE PHYSICIAN. THE PROGRAMMING TABLET WAS RECEIVED FOR ANALYSIS; HOWEVER, THE USB TO DB9 CABLE WAS NOT RETURNED. ANALYSIS OF THE TABLET WAS COMPLETED ON (B)(4) 2014. NO ANOMALIES ASSOCIATED WITH THE TABLET PERFORMANCE WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE TABLE WAS ABLE TO POWER ON AND BOOT TO THE VNS SOFTWARE WITH NO OBSERVED ANOMALIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290879 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS MODEL 250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1