BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2443751 · Received January 23, 2012

    Report

    Report Number
    1644487-2012-00180
    Event Type
    Malfunction
    Date Received
    January 23, 2012
    Date of Event
    March 26, 2009
    Report Date
    January 17, 2012
    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 A REVIEW THE PT'S PROGRAMMING HISTORY, IT WAS NOTICED THAT A PARTIAL PROGRAMMING EVENT OCCURRED ON (B)(6) 2009 FOLLOWING INTERROGATION WHICH RESULTED IN THE PT'S DEVICE BEING REPROGRAMMED TO 0MA. THE SETTINGS WERE NOT REPROGRAMMED PRIOR TO THE PT LEAVING THE CLINIC. THE SETTINGS WERE REPROGRAMMED ON THE FOLLOW UP VISIT ON (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS INC 258

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR