BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 502775 · Received December 24, 2003

    Report

    Report Number
    3003742446-2003-00775
    Event Type
    Death
    Date Received
    December 24, 2003
    Date of Event
    October 30, 2003
    Report Date
    December 22, 2003
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SAT POST STENT IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG ELUTING STENT NIQ CORDIS LLC (PR) NA Y0803442

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death THE PATIENT'S MEDICATIONS WERE POTASSIUM CHLORIDE,| INSULIN, FUROSEMIDE, ALBUTEROL, NORTRIPTYLINE, &| ASPIRIN.