BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1761275 · Received July 15, 2010

    Report

    Report Number
    1644487-2010-01637
    Event Type
    Malfunction
    Date Received
    July 15, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 18, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MFR THAT A NURSE'S PROGRAMMING SYSTEM WAS NOT WORKING BECAUSE THE SCREEN WAS FREEZING WHILE PERFORMING DIAGNOSTIC INTERROGATIONS. PERFORMING TROUBLESHOOTING BY REMOVING THE FLASHCARD AND REINSERTING IT BACK IN OR TURNING THE DEVICE OFF AND ON DID NOT RESOLVE THE ISSUE. GOOD FAITH ATTEMPTS TO OBTAIN PRODUCT INFO AND PRODUCT RETURN HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1