BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST JUDE MEDICAL

    MDR report key: 904114 · Received August 23, 2007

    Report

    Report Number
    MW5003537
    Event Type
    Malfunction
    Date Received
    August 23, 2007
    Date of Event
    December 21, 2006
    Report Date
    August 20, 2007
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ATRIAL LEAD DISLODGEMENT RATE MUCH HIGHER THAN OTHER COMPARABLE ATRIAL LEADS. DISLODGEMENT OCCURS WITH LEAD BEING PULLED OUT OF VASCULAR SYSTEM DESPITE ADEQUATE PRECAUTION DURING ATRIAL LEAD INSERTION AND TESTING PRIOR TO DISCHARGE. MOST DISLODGEMENTS OCCUR IN 6-8 WEEK PERIODS POST DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL ATRIAL LEAD 1788TC DTB

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other