BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2050202 · Received April 1, 2011

    Report

    Report Number
    1644487-2011-00701
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    June 22, 2006
    Report Date
    March 3, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING/DEVICE DIAGNOSTIC HISTORY.

    Description of Event or Problem · 1

    DURING A REVIEW OF A PT'S PROGRAMMING HISTORY AVAILABLE IN THE MFR'S PROGRAMMING HISTORY DATABASE, IT WAS FOUND THAT THE PT PRESENTED SETTINGS DIFFERENT THAN WHAT WAS INTENDED DURING AN OFFICE VISIT ON (B)(6) 2006. THE SETTINGS OCCURRED DUE TO A FAULTED SYSTEMS DIAGNOSTIC TEST ON (B)(6) 2006. A FINAL INTERROGATION WAS PERFORMED AS WELL AS ADD'L PROGRAMMING; HOWEVER, THE OFF TIME WAS LEFT AT 60 MINUTES. THE PHYSICIAN BEGAN LOWERING THE OFF TIME AT SUBSEQUENT OFFICE VISITS. THERE WERE NO REPORTS OF ANY PT ADVERSE EVENTS AS A RESULT. THE PHYSICIAN HAS BEEN INSTRUCTED TO PERFORM FINAL INTERROGATIONS AT THE END OF EACH OFFICE VISIT TO ENSURE THE SETTINGS ARE AS INTENDED. ON (B)(6) 2006 - PROGRAM - OUTPUT CURRENT: 2 MA, SIGNAL FREQUENCY: 30 HZ, PULSE WIDTH: 500 USEC, ON TIME: 30 SECONDS. OFF TIME: 5 MINUTES, MAGNET OUTPUT CURRENT: 1MA, MAGNET PULSE WIDTH: 500 USEC, MAGNET ON TIME: 30 SECONDS. ON (B)(6) 2006 - SYSTEMS DIAGNOSTICS - FAULT. ON (B)(6) 2006 - 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, MAGNET PULSE WIDTH: 500, MAGNET ON TIME: 30 SECONDS. ON (B)(6) 2006 - PROGRAM - OUTPUT CURRENT: 2.25 MA, SIGNAL FREQUENCY: 30 HZ, PULSE WIDTH: 500 USEC, ON TIME: 30 SECONDS, OFF TIME: 60 MINUTES, MAGNET OUTPUT CURRENT: 1MA, MAGNET PULSE WIDTH: 500 USEC, MAGNET ON TIME: 30 SECONDS. ON (B)(6)2006 - PROGRAM - OUTPUT CURRENT: 2.25 MA, SIGNAL FREQUENCY: 30 HZ, PULSE WIDTH: 500 USEC, ON TIME: 30 SECONDS. OFF TIME: 45 MINUTES, MAGNET OUTPUT CURRENT: 1MA, MAGNET PULSE WIDTH: 500 USEC, MAGNET ON TIME: 30 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 364714

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR