BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2821517 · Received November 6, 2012

    Report

    Report Number
    1644487-2012-02908
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    April 29, 2010
    Report Date
    November 5, 2012
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    DURING REVIEW OF THE IN-HOUSE PROGRAMMING/DIAGNOSTIC HISTORY DATABASE, IT WAS OBSERVED THAT A FAULTED SYSTEM DIAGNOSTIC TEST OCCURRED ON (B)(6) 2010 WHICH CHANGED THE PATIENT'S SETTINGS TO UNINTENDED PARAMETERS. THE SETTINGS WERE NOT CORRECTED PRIOR TO THE PATIENT LEAVING THE OFFICE DESPITE A FINAL INTERROGATION PERFORMED BY THE PHYSICIAN. THE SETTINGS WERE CORRECTED ON (B)(6) 2010. NO PATIENT ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC MODEL 250 521383

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR