BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2961157 · Received February 14, 2013

    Report

    Report Number
    1644487-2013-00400
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    December 1, 2009
    Report Date
    January 17, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    DURING REVIEW OF THE MANUFACTURER'S PROGRAMMING HISTORY DATABASE, IT WAS OBSERVED THAT A FAULTED SYSTEM DIAGNOSTIC TEST OCCURRED ON (B)(6) 2009 WHICH CHANGED THE PATIENT'S SETTING TO UNINTENDED PARAMETERS. A FINAL INTERROGATION WAS NOT PERFORMED, SO THE SETTINGS WERE NOT IDENTIFIED OR CORRECTED PRIOR TO THE PATIENT LEAVING THE CLINIC. UPON INITIAL INTERROGATION ON (B)(6) 2010, THE SETTINGS WERE AT UNINTENDED PARAMETERS, BUT THEY WERE CORRECTED AT THIS VISIT. MANUFACTURER LABELING INDICATES TO PERFORM FINAL INTERROGATIONS PRIOR TO PATIENTS LEAVING THE CLINIC TO IDENTIFY SUCH PROGRAMMING ANOMALIES. NO PATIENT ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65645 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC MODEL 250 523500

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR