BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS RGA

    MDR report key: 7918102 · Received September 18, 2018

    Report

    Report Number
    7918102
    Event Type
    Injury
    Date Received
    September 18, 2018
    Date of Event
    August 25, 2018
    Report Date
    September 14, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LDF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IN CATH LAB FOR TEMP PACER. PHYSICIAN USED 5FR BALLOON TIPPED PACING CATHETER, BUT UNABLE TO CAPTURE HR. TROUBLE SHOOTING INCLUDED CHANGING PACER BOX, PACER WIRES, AND FINALLY PACER CATHETER, WHICH OBTAINED IMMEDIATE CAPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724871 EDWARDS RGA SWAN-GANZ BIPOLAR PACING CATH LDF EDWARDS LIFESCIENCES 2018-08074-1

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Life Threatening