BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 549469 · Received October 15, 2004

    Report

    Report Number
    MW1033584
    Event Type
    Malfunction
    Date Received
    October 15, 2004
    Date of Event
    October 6, 2004
    Report Date
    October 12, 2004
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    COMPLAINED OF RIGHT SIDED TINGLING, NUMBNESS, AND CHEST PAIN; HEART CATHETERIZATION IDENTIFIED 95% - STENOSIS; DEPLOYED DES TO LAD WITHOUT DOCUMENTED PROBLEMS. DISMISSED ON PLAVIX 75 MG EVERY DAY. THREE DAYS LATER AFTER LIFTING DEVELOPED RETROSTERNAL CP RADIATING TO UE, NTG WITHOUT IMPROVEMENT - ADMITTED, NEW IMPRESSION; "NSTEMI." THE NEXT DAY CATHETERLIZATION REVEALED 100% OCCLUSION OF STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC TAXUS EXPRESS2 STENT OTW NIQ BOSTON SCIENTIFIC CORP. TAXUS EXPRESS2 OTW 6748948

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other