BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 4210382 · Received October 29, 2014

    Report

    Report Number
    1644487-2014-02877
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 22, 2014
    Report Date
    October 2, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    ANALYSIS OF THE HANDHELD WAS COMPLETED ON 11/07/2014. NO ANOMALIES ASSOCIATED WITH THE MAIN BATTERY WERE IDENTIFIED DURING THE ANALYSIS. DURING THE ANALYSIS, IT WAS IDENTIFIED THAT THE HANDHELD WOULD NOT POWER ON. THE CAUSE FOR THE ANOMALY IS ASSOCIATED WITH FLUID DAMAGE ON THE MAIN PCB. ONCE THE PCB WAS REPLACED, NO FURTHER ANOMALIES ASSOCIATED WITH THE HANDHELD WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. ANALYSIS OF THE FLASHCARD WAS COMPLETED ON 11/07/2014. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN'S HANDHELD WILL NOT CHARGE. THE PHYSICIAN LEFT THE HANDHELD PLUGGED INTO THE ELECTRICAL OUTLET FOR FOUR STRAIGHT DAYS AND IT STILL WOULD NOT CHARGE. THE BATTERY WAS REMOVED AND REINSERTED, BUT THIS DID NOT RESOLVE THE ISSUE. THE PHYSICIAN WAS PROVIDED A NEW PROGRAMMING COMPUTER. THE HANDHELD AND FLASHCARD WERE RECEIVED FOR ANALYSIS. ANALYSIS IS UNDERWAY, BUT HAS NOT BEEN COMPLETED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691639 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1063528

    Patients

    Seq Age Sex Outcome Treatment
    1