BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3231862 · Received July 17, 2013

    Report

    Report Number
    1644487-2013-02157
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    January 12, 2010
    Report Date
    June 26, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Additional Manufacturer Narrative · 1

    REPORT #0 INADVERTENTLY LISTED WRONG AGE AT TIME OF EVENT BASED ON INCORRECT EVENT DATE. REPORT #0 INADVERTENTLY LISTED WRONG DATE OF EVENT. REPORT #0 INADVERTENTLY LISTED WRONG EVENT DESCRIPTION BASED ON INCORRECT EVENT DATE. REPORT #0 INADVERTENTLY LISTED WRONG RELEVANT DATA AND DATES BASED ON INCORRECT EVENT DATE. REPORT #0 INADVERTENTLY LISTED INCORRECT SOFTWARE VERSION # BASED ON INCORRECT EVENT DATE.

    Description of Event or Problem · 1

    DURING A REVIEW OR PROGRAMMING HISTORY ON (B)(6) 2013 IT WAS NOTED THAT ON ONE OCCASION AN ANOMALY WAS IDENTIFIED AS HAVING OCCURRED ON (B)(6) 2011 DUE TO A FAULTED SYSTEMS DIAGNOSTICS TEST, RESULTING IN A CHANGE OF THE GENERATOR PARAMETERS. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    DURING A REVIEW OR PROGRAMMING HISTORY ON (B)(4) 2013 IT WAS NOTED THAT ON ONE OCCASION AN ANOMALY WAS IDENTIFIED AS HAVING OCCURRED ON (B)(6) 2011 DUE TO A FAULTED SYSTEMS DIAGNOSTICS TEST, RESULTING IN A CHANGE OF THE GENERATOR PARAMETERS. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MDR REPORT #0, MFR. REPORT #1644487-2013-02157, PREVIOUSLY REPORTED THE PROGRAMMING ANOMALY AS HAVING OCCURRED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330491 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR