BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2062321 · Received April 12, 2011

    Report

    Report Number
    1644487-2011-00786
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    August 15, 2005
    Report Date
    March 18, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    DURING A REVIEW OF A PT'S PROGRAMMING HISTORY AVAILABLE IN THE MANUFACTURER'S PROGRAMMING HISTORY DATABASE, IT WAS FOUND THAT THE PT PRESENTED SETTINGS DIFFERENT THAN WHAT WAS INTENDED DURING IMPLANT ON (B)(6) 2005. THE SETTINGS OCCURRED DUE TO A FAULTED SYSTEMS DIAGNOSTIC TEST ON (B)(6) 2005. AN INTERROGATION OF THE DEVICE WAS PERFORMED, AND THE NORMAL MODE CURRENT SETTING WAS ADJUSTED BACK TO OFF. THE MAGNET MODE CURRENT WAS NOT CORRECTED. AT THE NEXT REPORTED OFFICE VISIT (B)(6) 2006, THE MAGNET CURRENT WAS STILL UNCHANGED. THERE WERE NO REPORTS OF ANY PT ADVERSE EVENTS AS A RESULT. ON (B)(6) 2005 - INTERROGATE - OUTPUT CURRENT: 0 MA, SIGNAL FREQUENCY: 30 HZ, PULSE WIDTH: 500 USEC, ON TIME: 30 SECONDS, OFF TIME: 180 MINUTES; MAGNET OUTPUT CURRENT: 0 MA, PULSE WIDTH: 500 USEC, ON TIME: 60 SECONDS. ON (B)(6) 2005 - SYSTEMS DIAGNOSTICS - FAULT. ON (B)(6) 2005 - INTERROGATE - OUTPUT CURRENT: 1 MA, SIGNAL FREQUENCY: 20 HZ, PULSE WIDTH: 500 USEC, ON TIME: 30 SECONDS, OFF TIME: 60 MINUTES, MAGNET OUTPUT CURRENT: 1 MA, PULSE WIDTH: 500 USEC, ON TIME: 30 SECONDS. ON (B)(6) 2005 - PROGRAM - OUTPUT CURRENT: 0 MA, SIGNAL FREQUENCY: 20 HZ, PULSE WIDTH: 500 USEC, ON TIME: 30 SECONDS, OFF TIME: 60 MINUTES, MAGNET OUTPUT CURRENT: 1 MA, PULSE WIDTH: 500 USEC, ON TIME: 30 SECONDS. ON (B)(6) 2005 - INTERROGATE - OUTPUT CURRENT: 0 MA, SIGNAL FREQUENCY: 20 HZ, PULSE WIDTH: 500 USEC, ON TIME: 30 SECONDS, OFF TIME: 60 MINUTES, MAGNET OUTPUT CURRENT: 1 MA, PULSE WIDTH: 500 USEC, ON TIME: 30 SECONDS. ON (B)(6) 2006 - INTERROGATE - OUTPUT CURRENT: 1 MA, SIGNAL FREQUENCY: 20 HZ, PULSE WIDTH: 500 USEC, ON TIME: 60 SECONDS, OFF TIME: 60 MINUTES, MAGNET OUTPUT CURRENT: 1 MA, PULSE WIDTH: 500 USEC, ON TIME: 30 SECONDS. ON (B)(6) 2006 - PROGRAM - OUTPUT CURRENT: 1.25 MA, SIGNAL FREQUENCY: 20 HZ, PULSE WIDTH: 500 USEC, ON TIME: 60 SECONDS, OFF TIME: 60 MINUTES, MAGNET OUTPUT CURRENT: 1 MA, PULSE WIDTH: 500 USEC, ON TIME: 30 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 366954

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR