BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1921898 · Received December 8, 2010

    Report

    Report Number
    1644487-2010-02748
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    April 7, 2005
    Report Date
    November 8, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    WHILE REVIEWING THE PROGRAMMING HISTORY FOR THE PT'S VNS, IT WAS FOUND THAT A FAULTED DIAGNOSTICS TEST OCCURRED THAT ALTERED THE PT'S SETTINGS. THIS WAS NOTICED BY THE PHYSICIAN HOWEVER, THE OFF TIME WAS NOT CORRECTED UNTIL THE NEXT VISIT RESULTING IN THE PT LEAVING THE OFFICE WITH UNINTENDED SETTINGS. NO ADVERSE EVENTS HAVE BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR