BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING WAND

    MDR report key: 1172590 · Received September 19, 2008

    Report

    Report Number
    1644487-2008-02244
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 20, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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

    IT WAS REPORTED THAT THE NURSE HAD DIFFICULTY PROGRAMMING A PATIENT'S DEVICE. SHE REPORTED THAT WHILE THE POWER LIGHT IN THE PROGRAMMING WAND WAS ON AND THE DATA LIGHT WAS BLINKING, THEY COULD NOT GET THE WAND TO INTERROGATE THE PATIENT'S DEVICE. THE BATTERY WAS REPLACED AND THE ISSUE CONTINUED. THE NURSE CHANGED OUT THE WAND AND THE PROBLEM WAS RESOLVED. THE WAND WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS AND REPORTED EVENT WAS CONFIRMED. THE CABLE WAS VISUALLY EXAMINED AND NO ANOMALIES WERE IDENTIFIED. ADDITIONAL ANALYSIS SHOWED THAT THE ERROR ORIGINATED IN THE SERIAL DATA CABLE THAT HAD AN INTERMITTENT CONDUCTOR. THE CABLE WAS REPLACED WITH A KNOWN GOOD SERIAL DATA CABLE AND ALL THE COMMUNICATION ERRORS CLEARED. THE WAND WITH THE NEW SERIAL DATA CABLE PASSED ALL FUNCTIONAL TESTS AND WAS OPERATING WITH THE LIMITS OF THE FINAL ELECTRICAL TEST REQUIREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING WAND LYJ CYBERONICS, INC. 201

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR