BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3060847 · Received April 16, 2013

    Report

    Report Number
    1644487-2013-01029
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    July 27, 2006
    Report Date
    March 20, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY (IF APPLICABLE).

    Description of Event or Problem · 1

    ON (B)(4) 2013 REVIEW OF THE PATIENT'S PROGRAMMING HISTORY REVEALED THAT ON (B)(6) 2006 A PARTIAL PROGRAMMING OCCURRED THAT CHANGED THE PATIENT'S SETTINGS. THIS WAS NOT OBSERVED UNTIL THE NEXT DAY WHEN THE SETTINGS WERE CORRECTED. NO ADVERSE EVENTS WERE REPORTED TO HAVE OCCURRED DUE TO THIS SETTINGS CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162624 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC MODEL 250 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR