BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2955759 · Received February 11, 2013

    Report

    Report Number
    1644487-2013-00362
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    June 15, 2010
    Report Date
    June 7, 2012
    Manufacturer
    CYBERONICS INC
    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

    MANUFACTURER REVIEW OF A PATIENT'S VNS PROGRAMMING HISTORY IDENTIFIED THAT TWO FAULTED SYSTEMS DIAGNOSTICS TESTS OCCURRED ON (B)(6) 2010 AT 11:24:16 AND 11:25:58, FOLLOWED BY A SUCCESSFUL SYSTEMS TEST AT 11:28:36. A FINAL INTERROGATION WAS DONE AT 11:30:46, BUT IT WAS NOT NOTED THAT THE SETTINGS CHANGED; THE SETTINGS WERE 0MA/30HZ/250PULSEWIDTH/30SEC ON/5MIN OFF/0MA MAG/250PULSEWIDTH/30SEC ON. AT THE NEXT RECORDED OFFICE VISIT ON (B)(6) 2010, THE INITIAL INTERROGATION AT 11:09:45 RESULTED IN SETTINGS OF 0MA/30HZ/250PULSEWIDTH/30SEC ON/5MIN OFF/0MA MAG/250PULSEWIDTH/30SEC ON. THE SETTINGS WERE THEN CHANGED TO 1MA/30HZ/250PULSEWIDTH/30SEC ON/5MIN OFF/1.25MA MAG/250PULSEWITH/30SEC ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58023 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR