BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1760897 · Received July 14, 2010

    Report

    Report Number
    1644487-2010-01625
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Date of Event
    June 14, 2010
    Report Date
    June 14, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SITE WAS RECEIVING FAILURE TO ESTABLISH COMMUNICATION ERROR MESSAGES USING THEIR PROGRAMMING SYSTEM. TROUBLESHOOTING WAS DONE OVER THE PHONE, AND IDENTIFIED THAT THE SERIAL ADAPTER CORD CONNECTION INTO THE HAND HELD WAS LOOSE AND WAS NOT ABLE TO BE TIGHTENED. THE NURSE MOVED THE CORD, AND WAS ABLE TO ESTABLISH COMMUNICATION WITH THE PT'S GENERATOR EVENTUALLY. THE SITE WAS SENT A NEW PROGRAMMING SYSTEM TO REPLACE THE NON-WORKING DEVICE. ATTEMPTS TO OBTAIN THE NON-WORKING HAND HELD AND SERIAL ADAPTER CABLE ARE UNDERWAY, HOWEVER, THE DEVICE HAS NOT BEEN RETURNED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 521391

    Patients

    Seq Age Sex Outcome Treatment
    1