BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 485575 · Received September 23, 2003

    Report

    Report Number
    1644487-2003-00614
    Event Type
    Injury
    Date Received
    September 23, 2003
    Date of Event
    August 18, 2003
    Report Date
    August 25, 2003
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT VNS DEPRESSION PATIENT WAS HOSPITALIZED FOR SUICIDAL CRISIS. MEDICATION WAS DISCONTINUED AND A MAO-INHIBITOR (NORDIL) WAS STARTED. FURTHER FOLLOW-UP REVEALED THAT THE PATIENT REMAINS HOSPITALIZED AND THE SUICIDAL IDEATION IS STILL PRESENT. VNS THERAPY HAS NOT BEEN DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 101 5692

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| L| R NCP BIPOLAR LEAD.