BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2250026 · Received September 15, 2011

    Report

    Report Number
    1644487-2011-02173
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    September 14, 2011
    Report Date
    September 14, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A VNS (B)(4) COMPUTER WAS FREEZING DURING THE "INTERROGATION SUCCESSFUL" SCREEN DURING A VNS IMPLANT SURGERY. A HARD RESET RESOLVED THE SCREEN FREEZING AND THE PATIENT'S VNS WAS ABLE TO BE SUCCESSFULLY INTERROGATED AND HAVE VNS DIAGNOSTICS PERFORMED. THE VNS COMPUTER WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC MODEL 250 834042

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR