BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3087407 · Received May 1, 2013

    Report

    Report Number
    1644487-2013-01173
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    March 9, 2007
    Report Date
    April 3, 2013
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    WHILE REVIEWING THE PROGRAMMING HISTORY FOR THE PATIENT'S VNS GENERATOR IT WAS NOTED THAT ON (B)(6) 2007 A FAULTED DIAGNOSTICS CHANGED THE SETTINGS TO UNDESIRABLE SETTINGS. ON (B)(6) 2013 THE PATIENT WAS PROGRAMMED AT OUTPUT CURRENT= 0 MA/ FREQUENCY= 30 HZ/ PULSE WIDTH= 500 USEC/ON TIME= 30 SEC/OFF TIME= 180 MIN / MAGNET OUTPUT CURRENT= 0 MA/ ON TIME= 60 SEC/ PULSE WIDTH= 500 USEC. LATER A FAULTED SYSTEM DIAGNOSTICS CAUSED THE SETTINGS TO CHANGE TO OUTPUT CURRENT= 1 MA/ FREQUENCY= 20 HZ/ PULSE WIDTH= 500 USEC/ON TIME= 30 SEC/OFF TIME= 60 MIN / MAGNET OUTPUT CURRENT= 1 MA/ ON TIME= 30 SEC/ PULSE WIDTH= 500 USEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189561 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR