BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2894845 · Received January 3, 2013

    Report

    Report Number
    1644487-2013-00032
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    August 28, 2007
    Report Date
    December 4, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    MUZ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    DURING MANUFACTURER REVIEW OF THE PATIENT'S VNS PROGRAMMING HISTORY, IT WAS NOTED A FAULTED SYSTEMS TEST OCCURRED ON (B)(6) 2007 WHICH CHANGED THE VNS PROGRAMMED SETTINGS. THE SETTINGS WERE ALL CORRECTED EXCEPT FOR THE MAGNET ON TIME, WHICH WAS PREVIOUSLY AT 0MA AND WAS NOW AT 1MA. THE MAGNET OUTPUT CURRENT WAS LATER CORRECTED ON (B)(6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2305 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE MUZ CYBERONICS INC MODEL 250 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR