BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1001277 · Received February 22, 2008

    Report

    Report Number
    1644487-2008-00358
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    December 19, 2007
    Report Date
    January 23, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A DELL HANDHELD COMPUTER WAS RETURNED TO MFR. IT WAS REPORTED THAT THE DATE COULD NOT BE PROGRAMMED. PRODUCT ANALYSIS WAS COMPLETED BY MFR, AND NO PERFORMANCE ANOMALIES WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 521374

    Patients

    Seq Age Sex Outcome Treatment
    1