BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2980928 · Received February 27, 2013

    Report

    Report Number
    1644487-2013-00533
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    July 11, 2010
    Report Date
    February 4, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    ON (B)(6) 2010, AN INTERRUPTED SYSTEM DIAGNOSTIC TEST OCCURRED THAT ALTERED THE NORMAL MODE OUTPUT CURRENT. THE SETTINGS WERE NOT RETURNED TO EFFICACIOUS VALUES PRIOR TO THE PATIENT LEAVING THE OFFICE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84273 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC MODEL 250 584960

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR