BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2991044 · Received March 6, 2013

    Report

    Report Number
    1644487-2013-00601
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 7, 2007
    Report Date
    February 6, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    A PROGRAMMING HISTORY REVIEW WAS PERFORMED WHICH FOUND THAT A FAULTED SYSTEM DIAGNOSTIC TEST OCCURRED ON (B)(6) 2007 WHICH CHANGED THE PATIENT'S SETTINGS. A FINAL INTERROGATION WAS NOT PERFORMED AND THE PATIENT'S SETTINGS WERE NOT ADJUSTED WITHIN THE SAME VISIT. UPON INITIAL INTERROGATION ON THE FOLLOWING VISIT, (B)(6) 2007, THE FAULTED SETTINGS WERE SEEN AND ADJUSTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95517 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC MODEL 250 521425

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR