BEUDAMED
    FDA Adverse Event Injury Summary report: N

    J & J CORDIS

    MDR report key: 547965 · Received July 1, 2004

    Report

    Report Number
    MW1032527
    Event Type
    Injury
    Date Received
    July 1, 2004
    Date of Event
    June 15, 2004
    Report Date
    July 1, 2004
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CYPHER DRUG ELUTING STENT PLACED. PLAVIX WAS A KNOWN BOWEL IRRITANT. PT REFUSED TO TAKE MEDICATION RESULTING IN A SUB ACUTE THROMBOSIS IN THE STENT TOTALLY BLOCKING FLOW. PT BACK TO CATH LAB 3 DAYS LATER AS AN EMERGENT PROCEDURE TO OPEN THE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J & J CORDIS CYPHER ELUTING STENT NIQ JOHNSON & JOHNSON CXS18250 Y0304065

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening| R