BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3121516 · Received May 21, 2013

    Report

    Report Number
    1644487-2013-01477
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(4) 2013 THE SERIAL CABLE WAS RETURNED FOR PRODUCT ANALYSIS. PRODUCT ANALYSIS IS STILL UNDERWAY AND HAS NOT YET BEEN COMPLETED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THE HANDHELD WAS UNRESPONSIVE WITH SEVERAL PATIENTS DURING CLINICAL. TROUBLESHOOTING OF PERFORMING A HARD RESET AND CHANGING THE WAND BATTERY WAS PERFORMED BUT THERE WAS NO IMPROVEMENT. ANOTHER PROGRAMMING SYSTEM HAD TO BE USED TO INTERROGATE THE PATIENTS. ADDITIONAL TROUBLESHOOTING WAS LATER PERFORMED AND THE HANDHELD SERIAL CABLE WAS IDENTIFIED TO BE FAULTY, CAUSING COMMUNICATION ISSUES. IT WAS STATED THAT THE PRODUCT WOULD BE RETURNED FOR PRODUCT ANALYSIS BUT IT HAS NOT BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    PRODUCT ANALYSIS ON THE (B)(4) SERIAL DATA CABLE ADAPTER WAS COMPLETED ON (B)(4) 2013. IT WAS FOUND THAT IT HAD INTERMITTENT CONDUCTORS AT THE HANDLE LOCATION. A KNOWN GOOD BENCH SERIAL DATA CABLE WAS SUBSTITUTED AND ALL COMMUNICATIONS ERRORS CLEARED. PRODUCT ANALYSIS ON THE HANDHELD AND FLASHCARD WAS ALSO COMPLETED. DURING THE ANALYSIS, NO ANOMALIES ASSOCIATED WITH THE HANDHELD PERFORMANCE WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224535 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1