BEUDAMED
    FDA Adverse Event Death Summary report: N

    NCP PULSE GENERATOR

    MDR report key: 426148 · Received October 30, 2002

    Report

    Report Number
    1644487-2002-00484
    Event Type
    Death
    Date Received
    October 30, 2002
    Date of Event
    September 28, 2002
    Report Date
    October 1, 2002
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE REPORTER INDICATED THAT THE PATIENT COMMITTED SUICIDE. RESULTS OF A LEAD TEST PERFORMED IN 09/2002 RESULTED IN A DCDC CODE OF 2 INDICATING THAT THE DEVICE WAS WORKING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NCP PULSE GENERATOR PULSE GENERATOR LYJ CYBERONICS, INC. 101 2998

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death DATE OF MFG 09/19/2000, STERILIZATION LOT NO. 759.| OXIS TURBUHAILER = 9MICROG/DAILY, PULMICORT| TURBOHAILER = 400-1600MICROG/DAILY.| 300MG/DAILY, STILNOCT, LOSEC MUPS = 40MG/DAILY,| MEDICATIONS: THERALON = 40MG/DAILY, ZOLOFT =| MODEL 300-20 NCP BIPOLAR LEAD, EXPIRE 09/30/2002,