BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3181720 · Received June 21, 2013

    Report

    Report Number
    1644487-2013-01869
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS OF THE HANDHELD CONFIRMED ALL QUALITY TESTS WERE PASSED PRIOR TO DISTRIBUTION. DEVICE FAILURE OCCURRED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    A VNS TREATING PHYSICIAN REPORTED THAT HE HAD A HANDHELD COMPUTER AND IT WAS NOT TURNING ON. THE LOCK BUTTON WAS NOT ENGAGED AND THE POWER LIGHT WAS LIT, INDICATING THAT THE HANDHELD WAS CHARGING. HOWEVER, IT WAS NOTED THAT THE LIGHT WAS GREEN AND FLASHING. A HARD RESET WAS PERFORMED AND IT WAS STILL NOT TURNING ON. THEY TRIED CHARGING THE HANDHELD WITH A DIFFERENT POWER CABLE AND THEN TURNING IT ON, AND THIS WAS NOT SUCCESSFUL. THE BATTERY IN THE HANDHELD COMPUTER IS INSERTED IN THE PROPER ORIENTATION THE HANDHELD HAS BEEN RETURNED FOR ANALYSIS AND COMPLETION IS PENDING.

    Description of Event or Problem · 1

    HANDHELD PA WAS COMPLETED ON (B)(4) 2013. ANALYSIS OF THE HANDHELD CONFIRMED THAT THE HHD DISPLAY HAD NO IMAGE DURING STARTUP. THE CAUSE FOR THE IDENTIFIED ANOMALY IS ASSOCIATED WITH A DEFECTIVE DISPLAY. ONCE THE DISPLAY WAS REPLACED WITH A KNOWN GOOD DISPLAY, NO FURTHER ANOMALIES WERE IDENTIFIED. ANALYSIS OF THE FLASHCARD WAS COMPLETED ON (B)(4) 2013. 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
    282141 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 874820

    Patients

    Seq Age Sex Outcome Treatment
    1