BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3071858 · Received April 22, 2013

    Report

    Report Number
    1644487-2013-01102
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    November 19, 2008
    Report Date
    March 24, 2013
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    THROUGH REVIEW OF PROGRAMMING HISTORY A DEFAULTED GENERATOR DIAGNOSTICS ON (B)(6) 2008 CAUSED THE GENERATOR TO CHANGE ITS SETTINGS TO UNDESIRABLE VALUES. ON VISIT (B)(6) 2008, THE PATIENT WAS PROGRAMMED AT SETTINGS OUTPUT CURRENT= 1.75 MA/ FREQUENCY= 20 HZ/ PULSE WIDTH= 250 USEC/ON TIME= 60 SEC/OFF TIME= 1.1 MIN / MAGNET OUTPUT CURRENT= 2 MA/ ON TIME= 60 SEC/ PULSE WIDTH= 250 USEC. A SYSTEM DIAGNOSTICS WAS THEN PERFORMED ON THE PATIENT'S VNS GENERATOR WHICH WAS FAULTED AND CHANGED THE PATIENT'S SETTINGS. NO INTERROGATION WAS PERFORMED BEFORE THE PATIENT LEFT THE OFFICE. DURING THE NEXT VISIT ON (B)(6) 2008, THE PATIENT'S VNS GENERATOR WAS INTERROGATED AND WAS FOUND AT 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= 500 SEC/ PULSE WIDTH= 30 USEC. THE PATIENT'S SETTINGS WERE THEN CHANGED TO OUTPUT CURRENT= 2 MA/ FREQUENCY= 20 HZ/ PULSE WIDTH= 250 USEC/ON TIME= 60 SEC/OFF TIME= 1.1 MIN / MAGNET OUTPUT CURRENT= 2.25 MA/ ON TIME= 60 SEC/ PULSE WIDTH= 250 USEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172728 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS MODEL 250 521380

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR