BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3233824 · Received July 18, 2013

    Report

    Report Number
    1644487-2013-02171
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    February 18, 2013
    Report Date
    July 15, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS NOTED THAT THE PHYSICIAN CALLED THE MANUFACTURER ON THE DATE OF THE EVENT, (B)(6) 2013, AND STATED THAT HE INTERROGATED THE DEVICE AND FOUND THAT THE DEVICE HAD BEEN DISABLED FOR UNKNOWN REASON ON AN UNKNOWN DATE. AT THE TIME THE PROGRAMMING HISTORY WAS UNKNOWN; HOWEVER, REVIEW OF THE PROGRAMMING HISTORY THAT WAS REPORTED ON THE INITIAL MDR INDICATES THAT THE DEVICE DISABLEMENT WAS DUE TO GENERATOR DIAGNOSTICS.

    Description of Event or Problem · 1

    DURING A REVIEW OR PROGRAMMING HISTORY ON (B)(6) 2013 IT WAS NOTED THAT ON ONE OCCASION AN ANOMALY WAS IDENTIFIED AS HAVING OCCURRED ON 02/18/2013 DUE TO A GENERATOR DIAGNOSTICS TEST, RESULTING IN A DISABLEMENT OF THE GENERATOR. THE GENERATOR WAS INTERROGATED AT A DIFFERENT SET OF PARAMETERS ON (B)(6) 2013. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334477 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR