BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II STEROX

    MDR report key: 2221745 · Received August 16, 2011

    Report

    Report Number
    2221745
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 27, 2011
    Report Date
    August 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE MD WAS UNABLE TO STABILIZE LEAD IN RIGHT VENTRICLE DURING PACEMAKER INSERTION AND OBTAIN SUFFICIENT PRESSURE NUMBERS. ANOTHER LEAD FROM THE SAME MANUFACTURER AND SAME MODEL WAS THEN USED. THERE WAS NO ADVERSE SEQUELLAE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II STEROX LEAD, PACEMAKER DTB BOSTON SCIENTIFIC 4457 611237

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR NO OTHER THERAPIES