BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMON NITINOL FILTER SYSTEM

    MDR report key: 1923316 · Received November 29, 2010

    Report

    Report Number
    2020394-2010-00349
    Event Type
    Malfunction
    Date Received
    November 29, 2010
    Report Date
    November 5, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K970099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE IS UNKNOWN. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE FILTER REMAINS IMPLANTED. THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY. NOTE: THIS EVENT COINCIDES TO VOLUNTARY MEDWATCH REPORT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT IN A VOLUNTARY MEDWATCH REPORT THAT PAIN WAS EXPERIENCED DURING THE PLACEMENT OF A VENA CAVA FILTER AND THE PAIN ALLEGEDLY HAS NOT SUBSIDED IN SIX YEARS. A CONSULTING PHYSICIAN REPORTEDLY TOLD THE PATIENT "THAT TWO OR THREE OF THE METAL RODS FROM THE FILTER ARE GOING THROUGH THE MUSCLE MASS IN THE SPINE." THE PATIENT HAS BEEN TREATED WITH NARCOTICS. THE PATIENT WISHES TO HAVE THE FILTER REMOVED, BUT HAS BEEN INFORMED THAT IT IS A PERMANENT FILTER AND CANNOT BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMON NITINOL FILTER SYSTEM DTK BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1