BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 162738 · Received April 13, 1998

    Report

    Report Number
    162738
    Event Type
    Death
    Date Received
    April 13, 1998
    Date of Event
    April 3, 1998
    Report Date
    April 10, 1998
    Manufacturer
    *
    Product Code
    GZE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    L.V.N. CAME ON DUTY AT 0700. PT'S LUNGS WERE CONGESTED. SHE GAVE PT A BATH, & CHANGED THE ADHESIVE TAPE WHICH KEPT THE PHRENIC NERVE STIMULATOR IN PLACE. PULSE OXIMETER ALARMED & O2 SATURATION WENT FROM 96% TO 86% WITHIN A FEW SECONDS. NO PULSE AT THIS TIME. 0820 911 CALLED & CPR STARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * Implant PHRENIC NERVE STIMULATOR GZE * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Death| O| S AGENCY PROVIDED CARE FROM 6/10/97.