BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3090787 · Received May 2, 2013

    Report

    Report Number
    1644487-2013-01231
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    January 2, 2007
    Report Date
    April 5, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    WHILE REVIEWING THE PATIENT¿S VNS GENERATOR PROGRAMMING HISTORY A SYSTEM FAULTED DIAGNOSTICS WAS NOTED TO HAVE LEFT THE PATENT WITH UNINTENDED SETTINGS. ON (B)(6) 2006 THE PATIENT LAST SETTINGS WERE OUTPUT CURRENT= 1.75 MA/ FREQUENCY= 30 HZ/ PULSE WIDTH= 250 ¿SEC/ON TIME= 21 SEC/OFF TIME= 1.1 MIN / MAGNET OUTPUT CURRENT= 2.5 MA/ PULSE WIDTH= 500 ¿SEC / ON TIME= 60 SEC. A SYSTEM DIAGNOSTICS WAS THEN PERFORMED WHICH FAULTED. NO FINAL INTERROGATION WAS THEN PERFORMED TO CHECK THE PATIENT'S SETTINGS. THE NEXT RECORDED VISIT ON (B)(6) 2013 THE PATIENT SETTINGS WERE OUTPUT CURRENT= 1 MA/ FREQUENCY= 20 HZ/ PULSE WIDTH= 500 ¿SEC/ON TIME= 30 SEC/OFF TIME= 60 MIN / MAGNET OUTPUT CURRENT= 1 MA/ PULSE WIDTH= 500 ¿SEC / ON TIME= 30 SEC. THIS EVENT IS CAPTURED IN MDR REPORT #: 1644487-2013-01230. ON (B)(6) 2007 THE PATIENT'S SETTINGS WAS STILL AT OUTPUT CURRENT= 1 MA/ FREQUENCY= 20 HZ/ PULSE WIDTH= 500 ¿SEC/ON TIME= 30 SEC/OFF TIME= 60 MIN / MAGNET OUTPUT CURRENT= 1 MA/ PULSE WIDTH= 500 ¿SEC / ON TIME= 30 SEC. A GENERATOR DIAGNOSTICS WAS THEN PERFORMED WHICH RESULTED THE PATIENT¿S SETTINGS TO CHANGE TO OUTPUT CURRENT= 0 MA/ FREQUENCY= 30 HZ/ PULSE WIDTH= 500 ¿SEC/ON TIME= 30 SEC/OFF TIME= 5 MIN / MAGNET OUTPUT CURRENT= 0 MA/ PULSE WIDTH= 500 ¿SEC / ON TIME= 60 SEC. ON (B)(6) 2007 THE PATIENT'S SETTINGS WAS THEN CORRECTED TO OUTPUT CURRENT= 0.25 MA/ FREQUENCY= 30 HZ/ PULSE WIDTH= 250 ¿SEC/ON TIME= 30 SEC/OFF TIME= 5 MIN / MAGNET OUTPUT CURRENT= 0.5 MA/ PULSE WIDTH= 500 ¿SEC / ON TIME= 60 SEC. THIS EVENT IS CAPTURED IN THIS MDR REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192149 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR