BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAXUS LIBERTE'

    MDR report key: 1790456 · Received August 9, 2010

    Report

    Report Number
    MW5017010
    Event Type
    Injury
    Date Received
    August 9, 2010
    Date of Event
    January 1, 2008
    Report Date
    August 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT HAD STENT PLACED WITHOUT BEING INFORMED ABOUT ACTION OF DEVICE. PT HAS DONE HER OWN PERSONAL RESEARCH BUT STILL HAS QUESTIONS THAT HAVE NOT BEEN ANSWERED. PT WOULD LIKE TO KNOW HOW DRUG IS ELUDED INTO BLOOD STREAM AND AT WHAT RATE AND INTERVAL. PAIN IN CHEST HAS BEEN WORSE SINCE IMPLANTATION. NO ONE HAS BEEN WILLING AND/OR ABLE TO ANSWER QUESTIONS ABOUT DEVICE. PACLITAXEL CORONARY STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAXUS LIBERTE' CORONARY DRUG ELUTING STENT NIQ BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other