BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3023772 · Received March 27, 2013

    Report

    Report Number
    1644487-2013-00838
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    April 1, 2010
    Report Date
    March 5, 2013
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    ON (B)(6) 2013 DURING REVIEW OF THE PATIENT'S PROGRAMMING HISTORY IT WAS DISCOVERED THAT A FAULTED SYSTEM DIAGNOSTICS TEST OCCURRED ON (B)(6) 2010 AND A FINAL INTERROGATION WAS NOT PERFORMED. AT THE PATIENT'S NEXT VISIT, THE SETTINGS WERE NOTED TO BE OUTPUT=0MA/FREQUENCY=20HZ/PULSE WIDTH=500USEC/ON TIME=30SEC/OFF TIME=5/MAGNET OUTPUT=0MA/MAGNET PULSE WIDTH=500USEC/MAGNET ON TIME=60SEC. PRIOR TO LEAVING THIS VISIT, THE PATIENT WAS RE-PROGRAMMED TO INTENDED SETTINGS. NO PATIENT ADVERSE EVENTS WERE REPORTED TO HAVE OCCURRED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125971 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS MODEL 250 678297

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR