BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2930037 · Received January 25, 2013

    Report

    Report Number
    1644487-2013-00070
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    August 11, 2009
    Report Date
    December 27, 2012
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    DURING A REVIEW OF PROGRAMMING HISTORY, IT WAS NOTED THAT A FAULTED SYSTEM DIAGNOSTIC TEST ALTERED THE NORMAL MODE OUTPUT CURRENT FOR THIS PATIENT'S DEVICE. THE EVENT WAS NOT CORRECTED AT THE TIME OF THE EVENT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35660 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR