BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3950085 · Received July 22, 2014

    Report

    Report Number
    1644487-2014-01838
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE HANDHELD, FLASHCARD AND PROGRAMMING WAND WERE RECEIVED FOR ANALYSIS. ANALYSIS OF THE WAND WAS COMPLETED ON 01/26/2015. NO VISUAL OR MECHANICAL ANOMALY WAS IDENTIFIED. CONTINUITY TESTING OF THE SERIAL DATA CABLE AND THE BATTERY CABLE PASSED. THE PROGRAMMING WAND PERFORMED ACCORDING TO FUNCTIONAL SPECIFICATIONS. ANALYSIS OF THE HANDHELD WAS COMPLETED ON 02/03/2015. 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. ANALYSIS OF THE FLASHCARD WAS COMPLETED ON 02/03/2015. 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

    THE PHYSICIAN REPORTED THAT HE WAS UNABLE TO INTERROGATE A PATIENT ALTHOUGH THE HANDHELD WORKED ON A PREVIOUS PATIENT. TROUBLESHOOTING DETERMINED THAT THE HANDHELD CAUSED THE FAILURE TO INTERROGATE. THE PHYSICIAN WAS PROVIDED A NEW PROGRAMMING COMPUTER. 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
    428406 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS, INC. MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR