BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 4771789 · Received May 14, 2015

    Report

    Report Number
    1644487-2015-04705
    Event Type
    Malfunction
    Date Received
    May 14, 2015
    Date of Event
    January 1, 2015
    Report Date
    April 20, 2015
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM; CORRECTED DATA: THE PREVIOUSLY SUBMITTED MDR INADVERTENTLY FAILED TO REPORT THE RESULTS OF PRODUCT ANALYSIS.

    Additional Manufacturer Narrative · 1

    NAME AND ADDRESS; CORRECTED DATA: THE PREVIOUSLY SUBMITTED MDR INADVERTENTLY FAILED TO PROVIDE THE INITIAL REPORTER OF THE EVENT. OCCUPATION; CORRECTED DATA: THE PREVIOUSLY SUBMITTED MDR INADVERTENTLY FAILED TO PROVIDE THE INITIAL REPORTER OF THE EVENT. DEVICE MANUFACTURE DATE; CORRECTED DATA: THE PREVIOUSLY SUBMITTED MDR INADVERTENTLY PROVIDED THE WRONG MANUFACTURE DATE FOR THE SUSPECT DEVICE. DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ANALYSIS WAS COMPLETED ON THE RETURNED PROGRAMMING HANDHELD. DURING THE ANALYSIS, IT WAS IDENTIFIED THAT THE HANDHELD WAS UNABLE TO ADVANCE PAST THE SCREEN ALIGNMENT UTILITY. THE CAUSE FOR THE DISPLAY ANOMALY IS ASSOCIATED WITH RESISTANCE VALUES BEING HIGHER THAN EXPECTED IN THE TOUCH SCREEN CIRCUITRY. NO FURTHER ANOMALIES ASSOCIATED WITH THE HANDHELD PERFORMANCE WERE IDENTIFIED DURING THE ANALYSIS. ANALYSIS WAS COMPLETED ON THE RETURNED PROGRAMMING SOFTWARE. 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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE ISSUE EXPERIENCED WAS THAT THE SCREEN WOULD FREEZE IN THE ALIGNMENT STEP AND NOT SHOW THE NEXT STEP OR MENU. THE ISSUE HAS BEEN ISOLATED TO THE PROGRAMMING HANDHELD. THE ISSUE OCCURRED REGARDLESS OF WHETHER THE HANDHELD WAS PLUGGED INTO A WALL OUTLET OR NOT. THERE IS NO KNOWN TRAUMA OR BAD STORAGE CONDITIONS FOR THE HANDHELD. THE PROGRAMMING HANDHELD AND SOFTWARE HAVE BEEN RECEIVED BY THE MANUFACTURER FOR ANALYSIS; HOWEVER, ANALYSIS HAS NOT BEEN COMPLETED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PROGRAMMING HANDHELD IS MALFUNCTIONING. ATTEMPTS TO OBTAIN ADDITIONAL RELEVANT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE. THE HANDHELD IS EXPECTED TO BE RETURNED FOR ANALYSIS, BUT HAS NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317023 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 1063529

    Patients

    Seq Age Sex Outcome Treatment
    1