BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRGRAMMING SOFTWARE

    MDR report key: 1172149 · Received September 18, 2008

    Report

    Report Number
    1644487-2008-02258
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 19, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NURSE HAD DIFFICULTY INTERROGATING MULTIPLE PATIENTS' DEVICES, BUT ONCE SHE USED A DIFFERENT HANDHELD DEVICE, SHE WAS ABLE TO INTERROGATE AND PROGRAM THE DEVICES SUCCESSFULLY. THE HANDHELD DEVICE AND WAND WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, AND ANALYSIS OF THE WAND IS COMPLETE. THERE WERE NO PERFORMANCE ISSUES OR OTHER ANOMALIES ASSOCIATED WITH THE WAND THAT HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE HANDHELD ANALYSIS WAS NOT COMPLETED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 521376

    Patients

    Seq Age Sex Outcome Treatment
    1