BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 484709 · Received September 17, 2003

    Report

    Report Number
    9610978-2003-00379
    Event Type
    Injury
    Date Received
    September 17, 2003
    Date of Event
    July 1, 2003
    Report Date
    September 17, 2003
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    NIQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SLIGHT ELEVATION OF CPK (215) AND TROPONIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG ELUTING STENT NIQ CORDIS EUROPA, N.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening