BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST. JUDE MEDICAL INC., TEMPORARY PACEMAKER

    MDR report key: 5811776 · Received July 19, 2016

    Report

    Report Number
    MW5063563
    Event Type
    Malfunction
    Date Received
    July 19, 2016
    Date of Event
    April 14, 2016
    Report Date
    July 1, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LDF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER SUCCESSFUL INSERTION OF PACER BALLOON, THE BALLOON LINE WAS FLUSHED WITH NORMAL SALINE. PACER STOPPED AND PT RETURNED TO CATH LAB. SYRINGE CAN BE REMOVED FROM PORT. NO LABELING OR MARKING ON BALLOON PORT THAT IDENTIFIES IT DIFFERENT FROM IV LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459057 ST. JUDE MEDICAL INC., TEMPORARY PACEMAKER TEMPORARY PACEMAKER LDF ST. JUDE MEDICAL, INC. 1458 Q

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR