BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 4077717 · Received September 10, 2014

    Report

    Report Number
    1644487-2014-02297
    Event Type
    Malfunction
    Date Received
    September 10, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 11, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CYBERONICS, INC. SUBMITS THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION, BASED ON INFORMATION THAT CYBERONICS HAS OBTAINED, BUT MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA.

    Description of Event or Problem · 1

    THE HANDHELD AND FLASHCARD WERE RECEIVED FOR ANALYSIS. ANALYSIS OF THE FLASHCARD WAS COMPLETED ON 10/23/2014. NO ANOMALIES ASSOCIATED WITH FLASHCARD SOFTWARE OR DATABASES WERE IDENTIFIED DURING THE FLASHCARD ANALYSIS. THE FLASHCARD AND SOFTWARE PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. ANALYSIS OF THE HANDHELD WAS COMPLETED ON 10/23/2014. NO ANOMALIES ASSOCIATED WITH THE HANDHELD WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. THE HANDHELD PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN'S HANDHELD WILL NOT POWER ON EVEN WHILED PLUGGED INTO AN ELECTRICAL OUTLET. A HARD RESET WAS ATTEMPTED; HOWEVER, DID NOT RESOLVE THE ISSUE. A NEW PROGRAMMING TABLET WAS PROVIDED TO THE PHYSICIAN. THE HANDHELD IS EXPECTED TO BE RETURNED FOR ANALYSIS; HOWEVER, HAS NOT BEEN RECEIVED TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE RETURNED HANDHELD WOULD NOT ALLOW TRANSMISSION OF DATA AND KEPT GIVING ERROR MESSAGE THAT NOT ALL DATA COULD BE RECEIVED PRIOR TO ITS RETURN. ATTEMPTS FOR THE CHARGING CABLE AND SERIAL CABLE FOR THE HHD WERE MADE AS THEY WERE NOT RETURNED PREVIOUSLY WITH THE HANDHELD. BOTH CABLES HAVE NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557673 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1075842

    Patients

    Seq Age Sex Outcome Treatment
    1