BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2093254 · Received May 3, 2011

    Report

    Report Number
    1644487-2011-00959
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PHYSICIAN'S HANDHELD WAS HAVING DIFFICULTY INTERROGATING PTS. THE PHYSICIAN WAS RECEIVING A FAILURE TO PROGRAM ERROR MESSAGE. A COMPANY REPRESENTATIVE WENT TO THE OFFICE TO TROUBLESHOOT THE ISSUE. THE RESET BUTTONS ON THE WAND WERE PRESSED AND THE POWER LIGHT REMAINED ON FOR MORE THAN 25 SECONDS. THE CONNECTIONS WERE CHECKED AND IT APPEARED THAT THE SERIAL CABLE THAT CONNECTS TO THE HANDHELD WAS LOOSE. THE SERIAL CABLE WAS UNPLUGGED AND WAS RECONNECTED TO THE HANDHELD. THE COMPANY REPRESENTATIVE THEN ATTEMPTED TO INTERROGATE HIS DEMO GENERATOR BUT WAS UNSUCCESSFUL. THE SERIAL CABLE WAS REPLACED WITH A KNOWN FUNCTIONING SERIAL CABLE AND THE DEMO GENERATOR WAS SUCCESSFULLY INTERROGATED. THE SERIAL CABLE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. PRODUCT ANALYSIS IS PLANNED BUT HAS NOT BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 784806

    Patients

    Seq Age Sex Outcome Treatment
    1