BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2161109 · Received June 17, 2011

    Report

    Report Number
    1644487-2011-01378
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    April 20, 2009
    Report Date
    May 19, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    DURING THE REVIEW OF THE PROGRAMMING HISTORY, A PROGRAMMING ANOMALY WAS OBSERVED. THE GENERATOR WAS RETURNED TO THE MFR SET TO SETTINGS WHICH DO NOT APPEAR TO BE TYPICAL FOR THE PT GIVEN THE HISTORY AND KNOWN DUTY CYCLE. THIS COULD POTENTIALLY BE A CROSS-PROGRAMMING ISSUE OR INTERRUPTION IN DIAGNOSTICS, HOWEVER, DUE TO LACK OF INFO, THIS CANNOT BE CONFIRMED. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    A PROGRAMMING HISTORY REVIEW WAS PERFORMED WHICH FOUND THAT THE CHANGED SETTINGS WERE DUE TO A FAULTED SYSTEM DIAGNOSTIC TEST. ON (B)(6) 2009, A FAULTED SYSTEM DIAGNOSTIC TEST WAS PERFORMED AND A FINAL INTERROGATION WAS NOT PERFORMED ON THE VNS DEVICE AFTERWARDS. THE PATIENT WAS NEXT SEEN (B)(6) 2009 AND FOUND TO BE PROGRAMMED TO DIFFERENT SETTINGS UPON INITIAL INTERROGATION. ALTHOUGH MOST OF THE PATIENT'S SETTINGS WERE ADJUSTED AT THIS VISIT, THE OFF TIME WAS NOT CHANGED FROM 60 MINUTES LEAVING THE PATIENT WITH AN INEFFICACIOUS DUTY CYCLE. THE MOST CURRENT PROGRAMMING INFORMATION AVAILABLE, FROM (B)(6) 2011, SHOWS THE PATIENT IS STILL SET TO 60 MINUTES OFF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 521389

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR