BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3895460 · Received June 25, 2014

    Report

    Report Number
    1644487-2014-01598
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    November 10, 2010
    Report Date
    May 28, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    DURING REVIEW OF THE IN-HOUSE PROGRAMMING/DIAGNOSTIC HISTORY DATABASE, IT WAS OBSERVED THAT ON OFFICE VISIT ON (B)(6) 2011 THE PATIENT'S SETTINGS WERE DIFFERENT THAN WHAT WERE PROGRAMMED AT THE PREVIOUS OFFICE VISIT ON (B)(6) 2010. THE SETTINGS FOUND WERE INDICATIVE OF A INTERRUPTED DIAGNOSTIC TEST; HOWEVER, REVIEW OF SYSTEM DIAGNOSTIC TESTING FROM OFFICE VISIT ON (B)(6) 2010 WAS WITHIN NORMAL LIMITS. THE DEVICE WAS NOT INTERROGATED PRIOR TO THE PATIENT LEAVING THE OFFICE ON (B)(6) 2010 AS RECOMMENDED BY DEVICE MANUFACTURER TO ENSURE THE DEVICE IS AT THE CORRECT SETTINGS; THEREFORE, THE SETTINGS WERE NOT CORRECTED PRIOR TO THE PATIENT LEAVING THE OFFICE. THE SETTINGS WERE CORRECTED ON (B)(6) 2011. NO PATIENT ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370334 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC MODEL 250 678293

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR