BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 494756 · Received November 6, 2003

    Report

    Report Number
    1644487-2003-00694
    Event Type
    Malfunction
    Date Received
    November 6, 2003
    Report Date
    October 7, 2003
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT UPON INTERROGATION OF PATIENT'S GENERATOR AT OFFICE VISIT, THE NORMAL MODE OUTPUT CURRENT WAS FOUND TO BE SET AT 0MA, INDICATING THAT THE PATIENT WAS NOT RECEIVING THERAPY. THE PATIENT HAD REPORTEDLY EXPERIENCED AN INCREASE IN SEIZURE ACTIVITY. INVESTIGATION TO DATE HAS BEEN UNABLE TO DETERMINE WHETHER THE DEVICE MALFUNCTIONED OR WHETHER USER ERROR DURING PREVIOUS PROGRAMMING SESSION HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI PULSE GENERATOR LYJ CYBERONICS, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR LOT NO. 9623C.| MODEL 300-20 NCP BIPOLAR LEAD, EXPIR DATE| 04/30/2000, DATE OF MFG 04/07/1998, STERILIZATION