BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2241435 · Received August 18, 2011

    Report

    Report Number
    1644487-2011-01883
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    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 INITIALLY REPORTED THAT THE HANDHELD BATTERY WOULD NOT HOLD A CHARGE. THE PRODUCT WAS RETURNED AND PRODUCT ANALYSIS WAS PERFORMED. ANA ANALYSIS WAS PERFORMED ON THE RETURNED HANDHELD AND NO ANOMALIES ASSOCIATED WITH THE MAIN BATTERY WERE IDENTIFIED DURING THE ANALYSIS. DURING THE ANALYSIS IT WAS IDENTIFIED THAT THE HANDHELD WAS UNABLE TO ESTABLISH COMMUNICATION WITH A KNOWN GOOD WAND AND GENERATOR. THE CAUSE OF THE ANOMALY IS ASSOCIATED WITH A BROKEN WIRE CONNECTION IN THE SERIAL CABLE. ONCE THE WIRE WAS SOLDERED ONTO THE SERIAL CABLE PCB, NO FURTHER ANOMALIES WERE IDENTIFIED. AN ANALYSIS WAS PERFORMED ON THE RETURNED WAND AND NO MECHANICAL ANOMALIES, VISUAL ANOMALIES, OR ANOMALIES WHICH WOULD AFFECT BATTERY LONGEVITY WERE IDENTIFIED. THE 9V BATTERY RETURNED WITH THE WANT WAS DEPLETED. CONTINUITY TESTING OF THE SERIAL DATA CABLE AND THE BATTERY CABLE PASSED AND AFTER THE BATTERY WAS SUBSTITUTED, THE PROGRAMMING WAND PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. AN ANALYSIS WAS PERFORMED ON THE FLASHCARD AND NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    FOLLOW UP WITH THE INITIAL REPORTER WAS PERFORMED AND IT WAS INDICATED THAT DEVICE MISHANDLING WAS NOT SUSPECTED, HOWEVER IT WAS REPORTED THAT THE HANDLE HELD DOES GET PASSED AROUND A LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 469051

    Patients

    Seq Age Sex Outcome Treatment
    1