BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 4411810 · Received December 30, 2014

    Report

    Report Number
    4411810
    Date Received
    December 30, 2014
    Date of Event
    September 23, 2014
    Report Date
    December 30, 2014
    Manufacturer
    TZ MEDICAL, INC
    Product Code
    DRF
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CARDIAC ABLATION, SUDDEN DECREASE IN BLOOD PRESSURE AND HEART MOTION COMPARED TO BASELINE. PERICARDIAL EFFUSION CONFIRMED AND RESOLVED WITH SUBSEQUENT PERICARDIOCENTESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858430 * CATHETER DRF TZ MEDICAL, INC * 0216108
    858431 LASSO ELECTROPHYSIOLOGY CATHETER CARDIAC CATHETER DRF BIOSENSE WEBSTER, INC * 17016816L
    858432 THERMOCOOL CARDIAC CATHETER OAD BIOSENSE WEBSTER, INC * 1719809
    858433 * CARDIAC CATHETER DRF BIOSENSE WEBSTER, INC * 17064830M
    858434 SOUNDSTAR CARDIAC CATHETER OBJ BIOSENSE WEBSTER, INC * *
    858545 NAVISTAR THERMOCOOL CARDIAC CATHETER OAD BIOSENSE WEBSTER, INC * 17072122M

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR NO OTHER THERAPIES