BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3200262 · Received July 1, 2013

    Report

    Report Number
    1644487-2013-02000
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    August 25, 2010
    Report Date
    June 4, 2013
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    DURING REVIEW OF PROGRAMMING HISTORY, IT WAS NOTED THAT A FAULTED SYSTEM DIAGNOSTIC TEST OCCURRED THAT ALTERED DEVICE SETTINGS. NOT ALL SETTINGS WERE CORRECTED AT THE SAME OFFICE VISIT. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298343 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS MODEL 250 857133

    Patients

    Seq Age Sex Outcome Treatment
    1