BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 4151789 · Received October 8, 2014

    Report

    Report Number
    1644487-2014-02582
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 REPORTED THAT THE PHYSICIAN'S HANDHELD HAS A BROKEN BATTERY LATCH. A NEW PROGRAMMING TABLET WAS PROVIDED TO THE PHYSICIAN. THE HANDHELD AND FLASHCARD WERE RECEIVED FOR ANALYSIS. ANALYSIS OF THE HANDHELD WAS COMPLETED ON (B)(4) 2014. THE CAUSE FOR THE ALLEGATION IS ASSOCIATED WITH A LOOSE SCREW THAT SECURES THE BATTERY LATCH TO THE HANDHELD CASE. ONCE THE SCREW WAS TIGHTENED, NO FURTHER ANOMALIES ASSOCIATED WITH THE HANDHELD PERFORMANCE WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. ANALYSIS OF THE FLASHCARD WAS COMPLETED ON (B)(4) 2014. 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
    632462 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS INC MODEL 250 1063830

    Patients

    Seq Age Sex Outcome Treatment
    1