BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 4180679 · Received October 17, 2014

    Report

    Report Number
    1644487-2014-02736
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    February 23, 2011
    Report Date
    September 22, 2014
    Manufacturer
    CYBERONICS INC
    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

    REVIEW OF THE AVAILABLE PROGRAMMING AND DIAGNOSTIC HISTORY.

    Description of Event or Problem · 1

    DURING REVIEW OF PROGRAMMING AND DIAGNOSTIC HISTORY, IT WAS OBSERVED THAT AN INTERRUPTED SYSTEM DIAGNOSTIC TEST OCCURRED THAT CAUSED AN UNINTENDED CHANGE IN DEVICE SETTINGS DURING AN OFFICE VISIT ON (B)(6) 2011. THE PHYSICIAN CORRECTED THE SETTINGS; HOWEVER, THE MAGNET ON TIME WAS NOT CORRECTED. NO PATIENT ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662538 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC MODEL 250 678298

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR