BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1081938 · Received July 23, 2008

    Report

    Report Number
    1644487-2008-01673
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 26, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER THAT THE SERIAL ADAPTER CABLE CONNECTION WAS LOOSE AND THE PHYSICIAN HAD TO HOLD IT UP IN ORDER FOR THE PROGRAMMING SYSTEM TO FUNCTION PROPERLY. A NEW SERIAL ADAPTER CABLE WAS SENT TO THE SITE AND THE PROBLEM RESOLVED WITH THE NEW CABLE. ATTEMPTS TO OBTAIN THE NON-WORKING CABLE FOR ANALYSIS HAVE BEEN MADE, BUT HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 523496

    Patients

    Seq Age Sex Outcome Treatment
    1