BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3983356 · Received August 6, 2014

    Report

    Report Number
    1644487-2014-01948
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 11, 2014
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VNS PATIENT¿S DEVICE SETTINGS WERE DIFFERENT THAN WHAT WAS PREVIOUSLY PROGRAMMED. THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL FOR SUBDURAL GRID PLACEMENT. ON (B)(6) 2014, THE PATIENT¿S DEVICE WAS DISABLED; HOWEVER, ON (B)(6) 2014, THE PATIENT¿S DEVICE WAS UNEXPECTEDLY FOUND TO BE PROGRAMMED BACK ON. THE SETTINGS WERE INDICATIVE OF AN INTERRUPTED SYSTEM DIAGNOSTIC TEST. REVIEW OF PROGRAMMING AND DIAGNOSTIC HISTORY DID NOT SHOW THE INITIAL DEVICE DISABLEMENT ON (B)(6) 2014. ON (B)(6) 2014, PATIENT¿S DEVICE WAS FOUND TO BE PROGRAMMED OFF. THE MAGNET MODE OUTPUT CURRENT WAS PROGRAMMED BACK ON, BUT AN INTERRUPTED SYSTEM DIAGNOSTIC TEST SUBSEQUENTLY OCCURRED THAT CAUSED AN UNINTENDED CHANGE IN DEVICE SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459935 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS MODEL 250 1075226

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR