BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3043559 · Received April 9, 2013

    Report

    Report Number
    1644487-2013-00962
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 1, 2013
    Report Date
    March 11, 2013
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PHYSICIAN WAS HAVING PROBLEMS WITH THE (B)(4) HANDHELD COMPUTER EVERY SO OFTEN WHICH INVOLVED THE SCREEN FREEZING AFTER THE INTERROGATION SUCCESSFUL SCREEN. DURING THESE EVENTS, THE SCREEN WOULD NOT PROCEED TO THE NEXT SCREEN. THE PHYSICIAN WAS PERFORMING HARD RESETS TO RESOLVE IT, BUT THE EVENT REPORTEDLY CONTINUED TO HAPPEN. A REPLACEMENT PROGRAMMING SYSTEM WAS PROVIDED TO THE PHYSICIAN. THE PROGRAMMING SYSTEM IN QUESTION WAS RETURNED TO DEVICE MANUFACTURER FOR ANALYSIS ON (B)(4) 2013. PRODUCT ANALYSIS FOR THE RETURNED HANDHELD COMPUTER AND SOFTWARE WAS COMPLETED. THE ALLEGED SCREEN FREEZE COMPLAINT IS A KNOWN ISSUE WHILE OPERATING IN THE (B)(4) HANDHELD COMPUTER. NO FURTHER TESTING IS REQUIRED FOR THIS PARTICULAR EVENT. OTHER THAN THE ABOVE MENTIONED OBSERVATIONS, THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. NO ISSUES WERE OBSERVED WITH THE RETUNED HANDHELD. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147003 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS MODEL 250 1073773

    Patients

    Seq Age Sex Outcome Treatment
    1