BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1963422 · Received December 20, 2010

    Report

    Report Number
    1644487-2010-02848
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 24, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A VNS PROGRAMMING PHYSICIAN REPORTED TO OUR COUNTRY REP THAT THEY HAD A HP JORNADA HANDHELD COMPUTER THAT HAD AN ISSUE WITH THE LIGHT ON THE SCREEN. REPORTED AS LIMITED LIGHT ON THE SCREEN. TROUBLE SHOOTING WAS REPORTED TO HAVE BEEN PERFORMED W/O IT GETTING BETTER. THEY COULD USE THE HANDHELD COMPUTER, BUT IT WAS NOT OPTIMAL. (B)(4) ATTEMPTS ARE UNDERWAY TO HAVE THE HANDHELD RETURNED FOR ANALYSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1