BEUDAMED
    FDA Adverse Event Injury Summary report: N

    J & J CORDIS

    MDR report key: 547745 · Received July 1, 2004

    Report

    Report Number
    MW1032526
    Event Type
    Injury
    Date Received
    July 1, 2004
    Date of Event
    April 7, 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

    PT PRESENTED TO ED WITH ACUTE MI, DES PLACED IN CIRC AND LAD. THREE DAYS LATER PT RETURNED TO ED WITH C/O CHEST PAIN. BOTH STENTS WERE FOUND TO BE TOTALLY OCCLUDED. BOTH STENTS OPENED WITH PTCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 J & J CORDIS CYPHER ELUTING STENT NIQ JOHNSON & JOHNSON CXS13250 A0204637

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| L| R