BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3926465 · Received July 10, 2014

    Report

    Report Number
    1644487-2014-01748
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 24, 2011
    Report Date
    June 12, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    DURING REVIEW OF THE IN-HOUSE PROGRAMMING/DIAGNOSTIC HISTORY DATABASE, IT WAS OBSERVED THAT DURING INTERROGATION ON OFFICE VISIT ON (B)(6) 2011 THE PATIENT'S SETTINGS FOUND WERE INDICATIVE OF A FAULTED DIAGNOSTIC TEST. THE SETTINGS WERE CORRECTED ON (B)(6) 2011. NO PROGRAMMING HISTORY WAS AVAILABLE PRIOR TO THIS DATE. IT IS LIKELY THAT THE FAULTED TEST OCCURRED AT THE PATIENT¿S IMPLANT ON (B)(6) 2011. NO PATIENT ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404122 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR