BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1455156 · Received June 2, 2009

    Report

    Report Number
    1644487-2009-01126
    Event Type
    Malfunction
    Date Received
    June 2, 2009
    Date of Event
    May 1, 2009
    Report Date
    May 7, 2009
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE OT A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SITE'S HANDHELD COMPUTER WAS CONSTANTLY FREEZING AND THEY HAD TO RESEAT THE FLASHCARD MULTIPLE TIMES WHEN USING IT ON A SINGLE PT. THEY ALSO HAD TO RESET THE PT'S PARAMETERS AFTER EVERY SYS TEST. FOLLOW-UP WITH THE SITE REVEALED THE FREEZE WAS HAPPENING UPON INTERROGATION AND ANYTIME DIAGNOSTICS WERE RUN. THEY TRIED IT IN DIFFERENT ROOMS, BUT THE PROBLEM PERSISTED. ONLY THE HANDHELD WAS RETURNED (WITHOUT THE SOFTWARE) TO THE MFR FOR ANALYSIS ON 05/14/2009. UPON ANALYSIS OF THE HANDHELD, NO ANOMALIES WERE NOTED AND THE DEVICE PERFORMED ACCORDING TO SPECS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 521426

    Patients

    Seq Age Sex Outcome Treatment
    1