BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2982866 · Received February 28, 2013

    Report

    Report Number
    1644487-2013-00550
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    March 19, 2004
    Report Date
    February 5, 2013
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    DURING REVIEW OF INHOUSE PROGRAMMING HISTORY VIEWED. ON (B)(6) 2004, THE DAY OF IMPLANT, THE DEVICE WAS INTERROGATED A COUPLE OF TIMES PROGRAMMED TO 0/30/500/30/180 TO STAY AT SHIPPING SETTINGS, 3 SYSTEM DIAGNOSTICS WERE PERFORMED AND THE DEVICE WAS INTERROGATED AND THE SETTINGS WERE 1.0 MA / 20 SF / 500 PW / 30 SECONDS ON TIME / 60 SECONDS OFF TIME AND THE DEVICE WAS NOT PROGRAMMED TO INTENDED SETTINGS PRIOR TO THE PATIENT LEAVING. THE PATIENT'S SETTINGS WERE CORRECTED ON 2/14/2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86388 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS MODEL 241635

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR