BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3250893 · Received July 29, 2013

    Report

    Report Number
    1644487-2013-02263
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    May 29, 2013
    Report Date
    July 2, 2013
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    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 PHYSICIAN¿S PROGRAMMING SYSTEM WAS NOT COMMUNICATING WITH PATIENTS. A HARD RESET WAS PERFORMED AND THE 9 VOLT BATTERY WAS REPLACED BUT THE PROGRAMMING SYSTEM WOULD NOT WORK. THE WAND, HANDHELD AND FLASHCARD WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. DURING THE ANALYSIS IT WAS IDENTIFIED THAT THE HANDHELD WAS UNABLE TO ESTABLISH COMMUNICATION WITH A KNOWN GOOD WAND AND GENERATOR. THE CAUSE FOR THE ANOMALY IS ASSOCIATED WITH 2 BROKEN WIRE CONNECTIONS IN THE SERIAL CABLE. ONCE THE WIRES WERE SOLDERED ONTO THE SERIAL CABLE PCB, NO FURTHER ANOMALIES WERE IDENTIFIED. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO SPECIFICATIONS. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. NO VISUAL OR MECHANICAL ANOMALY WAS IDENTIFIED WITH THE WAND. CONTINUITY TESTING OF THE SERIAL DATA CABLE AND THE BATTERY CABLE PASSED. THE PROGRAMMING WAND PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352457 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS MODEL 250 840143

    Patients

    Seq Age Sex Outcome Treatment
    1