BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2181429 · Received July 6, 2011

    Report

    Report Number
    1644487-2011-01496
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 6, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE WAS FOUND, 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 HANDHELD WOULD NOT POWER ON WHEN THE POWER BUTTON WAS PRESSED. IT WAS REPORTED THAT THE PHYSICIAN KEPT THE HANDHELDS PLUGGED IN ALL THE TIME AND AT THE TIME OF THE REPORT, THE HANDHELD HAD NOT BEEN USED WITHIN THE PAST WEEK. THE HANDHELD WAS NOT SHOWING THE ORANGE OR THE GREEN LIGHT. THREE DIFFERENT WORKING POWER OUTLETS WERE USED BUT THE HANDHELD STILL WOULD NOT POWER ON. THE HANDHELD IS STORED IN THE OFFICE. THE HANDHELD AND FLASHCARD WERE RETURNED TO THE MFR FOR EVAL. AN ANALYSIS WAS PERFORMED ON THE HANDHELD AND THE REPORTED ALLEGATION WAS VERIFIED. THE CAUSE FOR THE REPORTED ALLEGATION IS ASSOCIATED WITH A BLOWN FUSE IN THE HANDHELD. THE MOST LIKELY CAUSE FOR THE BLOWN FUSE IS ASSOCIATED WITH A DEFECTIVE SERIAL CABLE ASSOCIATED WITH ANOTHER HANDHELD IN THE PHYSICIAN OFFICE REPORTED IN MFR¿S REPORT NUMBER 1644487-2011-01508. NO FURTHER ANOMALIES WERE IDENTIFIED. 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
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 872008

    Patients

    Seq Age Sex Outcome Treatment
    1