BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1963424 · Received December 20, 2010

    Report

    Report Number
    1644487-2010-02851
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 23, 2010
    Manufacturer
    CYBERONICS INC
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY VNS PT'S SPOUSE THAT A VNS PT'S DEVICE WAS NOT AT THE INTENDED SETTINGS. ADDITIONALLY, THE TREATING PSYCHIATRIST NEEDED ASSISTANT IN RETRIEVING THE DATA FROM THE HANDHELD, BUT (B)(4) ATTEMPTS HAVE BEEN UNSUCCESSFUL TO DATE TO HELP THE PHYSICIAN. A REQUEST FOR PROGRAMMING HISTORY HAS BEEN SENT TO THE PSYCHIATRIST. (B)(4) TO OBTAIN ADD'L INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR