BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3043001 · Received April 9, 2013

    Report

    Report Number
    1644487-2013-00963
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    September 13, 2010
    Report Date
    April 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY PERFORMED.

    Description of Event or Problem · 1

    REVIEW OF THE PATIENT'S PROGRAMMING HISTORY AVAILABLE IN THE MANUFACTURER'S DATABASE REVEALED THAT A PROGRAMMING ANOMALY OCCURRED ON (B)(6) 2010 DUE TO A FAULTED SYSTEM DIAGNOSTIC TEST. A FINAL INTERROGATION WAS NOT PERFORMED PRIOR TO THE PATIENT LEAVING THE CLINIC. UPON INITIAL INTERROGATION ON (B)(6) 2011, THE SETTINGS WERE AT UNINTENDED PARAMETERS WITH THE OUTPUT CURRENTS AT 0MA. THE SETTINGS WERE CORRECTED ON THIS VISIT. MANUFACTURER LABELING INDICATES TO IDENTIFY AND FULLY CORRECT PROGRAMMING SETTINGS PRIOR TO PATIENT'S LEAVING THE CLINIC BY PERFORMING FINAL INTERROGATIONS. NO PATIENT ADVERSE EVENTS WERE REPORTED. THE PHYSICIAN HAS SINCE BEEN TRAINED ON IDENTIFYING AND CORRECTING PROGRAMMING ANOMALIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145192 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC MODEL 250 521403

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR