BEUDAMED
    FDA Adverse Event Death Summary report: N

    CONTOUR V-145AC

    MDR report key: 118733 · Received June 26, 1997

    Report

    Report Number
    118733
    Event Type
    Death
    Date Received
    June 26, 1997
    Date of Event
    May 16, 1997
    Report Date
    June 24, 1997
    Manufacturer
    VENTRITEX, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT FOUND PULSELESS ON 5/15/97, 2250-RESUSCITATED AND TRANSFERRED TO ICU, DIAGNOSTIC REPORT INDICATED DEVICE DELIVERED 750V (37.9J). AT 00:10, ASYSTOLE VERSUS, FINE V-FIB NOTED. DEVICE DELIVERED 750V (38.1J). TRANSCUTANEOUS PACER APPLIED WITH VARIABLE CAPTURE. LAST EVENT PER DIAGNOSTIC WAS AT 00:43 CARDIOVERSION WITH 750V (38.0J) AT 01:37, PULSELESS ELECTRICAL ACTIVITY EVEN WITH EXTERNAL PACING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR V-145AC Implant NA LWS VENTRITEX, INC. V-145AC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death 3. MEDTRONIC 6936| 1. CPI A67| 2. L67