BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2970058 · Received February 20, 2013

    Report

    Report Number
    1644487-2013-00460
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    August 28, 2009
    Report Date
    February 8, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    REVIEW OF THE MANUFACTURER'S PROGRAMMING HISTORY DATABASE WAS PERFORMED, AND IT WAS OBSERVED THAT A FAULTED SYSTEM DIAGNOSTIC TEST OCCURRED ON (B)(6) 2008 WHICH CHANGED THE SETTINGS TO UNINTENDED PARAMETERS. HOWEVER, THE SETTINGS WERE ALL CORRECTED PRIOR TO THE PATIENT LEAVING THE CLINIC ,EXCEPT FOR THE FREQUENCY WHICH WAS NEVER CHANGED BACK TO 30HZ. IT IS UNKNOWN IF THE SIGNAL FREQUENCY WAS INTENTIONALLY LEFT AT 20HZ. NO PATIENT ADVERSE EVENTS WERE REPORTED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73588 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC MODEL 250 675293

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR