BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2983341 · Received February 28, 2013

    Report

    Report Number
    1644487-2013-00552
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    July 24, 2007
    Report Date
    February 1, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    DURING REVIEW OF IN HOUSE PROGRAMMING HISTORY, IT WAS FOUND THAT A FAULTED DIAGNOSTIC TEST OCCURRED DURING THE IMPLANT SURGERY ON (B)(6) 2007, WHICH PROGRAMMED THE GENERATOR TO UNINTENDED SETTINGS. THE DEVICE WAS INTERROGATED PRIOR TO THE PATIENT LEAVING THE OR; HOWEVER, THE SETTINGS WERE NOT CHANGED. THE PATIENT WAS SEEN BY THE NEUROLOGIST THE FOLLWING DAY, AT WHICH TIME THE SETTINGS WERE ADJUSTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86875 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR