BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3062684 · Received April 17, 2013

    Report

    Report Number
    1644487-2013-01039
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    June 6, 2011
    Report Date
    March 25, 2013
    Manufacturer
    CYBERONICS
    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.

    Description of Event or Problem · 1

    DURING REVIEW OF THE PATIENT'S PROGRAMMING HISTORY ON (B)(6) 2013 IT WAS DISCOVERED THAT ON (B)(6) 2011 A SYSTEM DIAGNOSTICS TEST WAS PERFORMED WHICH CHANGED THE PATIENT'S SETTINGS. SOME OF THE SETTINGS WERE CORRECTED AFTERWARDS BUT THEN A SECOND FAULTED SYSTEM DIAGNOSTICS TEST OCCURRED WHICH CHANGED THE PATIENT'S SETTINGS AGAIN. THIS TIME THERE WAS NO FINAL INTERROGATION. IT WAS NOT UNTIL THE PATIENT'S NEXT VISIT ON (B)(6) 2011 THAT THE SETTINGS WERE PARTIALLY CORRECTED. ON (B)(6) 2012 THE PATIENT'S SETTINGS WERE COMPLETELY CORRECTED. NO PATIENT ADVERSE EVENTS WERE REPORTED TO HAVE OCCURRED DUE TO THESE SETTINGS CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166136 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS MODEL 250 839583

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR