BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACEL RIGHT HEART CURVE

    MDR report key: 757732 · Received June 23, 2006

    Report

    Report Number
    MW1040302
    Event Type
    Injury
    Date Received
    June 23, 2006
    Date of Event
    June 14, 2006
    Report Date
    June 23, 2006
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LDF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING HEART CATH PROCEDURE THE PATIENT DEVELOPED ASYSTOLE THAT WAS IMMEDIATELY RECOGNIZED AND CPR WAS INITIATED. THE RIGHT FEMORAL VEIN WAS QUICKLY ACCESSED WITH AN 18 GAUGE NEEDLE AND A 6-FRENCH VENOUS SHEATH WAS PLACED. A 5-FRENCH PACING ELECTRODE WAS ADVANCED AND PLACED IN THE RIGHT VENTRICULAR APEX. PACING WAS INITIATED BUT THERE WAS NO PACING OUTPUT. TROUBLESHOOTING WAS INITIATED - THE PACER CABLE AND THE PACER BOX WERE BOTH REPLACED WITH NO PACING OUTPUT. THE PACING ELECTRODE WAS REPLACED AND WE WERE ABLE TO PACE WITH GOOD OUTPUT AND CAPTURE. THE ST. JUDE MEDICAL REPRESENTATIVE HAPPENED TO HAVE BEEN IN THE FACILITY AND TOOK THE ELECTRODE, PACING BOX AND CABLE WITH HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PACEL RIGHT HEART CURVE TEMPORARY FLOW DIRECTED PACING CATHETER LDF ST. JUDE MEDICAL 401763 1215684

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening