BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYBERONICS NCP

    MDR report key: 223151 · Received May 12, 1999

    Report

    Report Number
    1644487-1999-00004
    Event Type
    Injury
    Date Received
    May 12, 1999
    Date of Event
    October 22, 1998
    Report Date
    May 12, 1999
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH LENNOX-GASTAUT SYNDROME WAS IMPLANTED WITH NEUROCYBERNETIC PROSTHESIS ON MARCH 3, 1998, WITH DEVICE ACTIVATION OCCURRING ONE WEEK LATER. ON 9/18/98, THE PULSE GENERATOR'S DUTY CYCLE WAS INCREASED. ON 10/22/98, PATIENT PRESENTED WITH CONSTIPATION, PROTEIN LOSS IN STOOL, PANCREATITIS, AND BLEEDING FROM G-TUBE SITE (G-TUBE PRESENT DUE TO PRE-EXISTING SWALLOWING DIFFICULTIES.) PATIENT WAS STARTED ON MYLANTA, AND PULSE GENERATOR SETTINGS WERE ADJUSTED TO INCREASE OUTPUT CURRENT AND DECREASE DUTY CYCLE. PATIENT'S GI SYMPTOMS SUBSEQUENTLY ABATED. ON 3/17/99, THE PULSE GENERATOR'S DUTY CYCLE WAS AGAIN INCREASED. ON 4/9/99, PATIENT PRESENTED WITH RECURRENCE OF GI SYMPTOMS. ON 4/9/99, THE DUTY CYCLE WAS DECREASED. BY 4/15/99, THERE WAS A NOTICEABLE IMPROVEMENT IN PATIENT'S GI SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYBERONICS NCP Implant NEUROSTIMULATOR LYJ CYBERONICS, INC. 100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Life Threatening| R