BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3864119 · Received June 10, 2014

    Report

    Report Number
    1644487-2014-01459
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 23, 2009
    Report Date
    May 15, 2014
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY.

    Description of Event or Problem · 1

    DURING REVIEW OF PROGRAMMING AND DIAGNOSTIC HISTORY, IT WAS OBSERVED THAT AN INTERRUPTED SYSTEM DIAGNOSTIC TEST OCCURRED THAT CAUSED AN UNINTENDED CHANGE IN DEVICE SETTINGS DURING AN OFFICE VISIT ON (B)(6) 2009. THE CHANGE IN DEVICE SETTINGS WAS FOUND DURING AN OFFICE VISIT ON (B)(6) 2009. NO PATIENT ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338314 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS MODEL 250 675293

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR