BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER OTW

    MDR report key: 528699 · Received May 24, 2004

    Report

    Report Number
    MW1032195
    Event Type
    Injury
    Date Received
    May 24, 2004
    Date of Event
    May 13, 2004
    Report Date
    May 24, 2004
    Manufacturer
    CORDIS CORP
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED WITH CHEST PAIN IN 2004. TAKEN TO THE CATH LAB THE FOLLOWING DAY AND A CYPHER DRUG ELUTING STENT WAS PLACED IN THE MID CIRC. THE FOLLOWING DAY, PT COMPLAINED OF CHILLS, DIAPHORESIS, SHAKING, REDNESS TO SKIN. THESE SYMPTOMS SUBSIDED ONLY AFTER TREATMENT WITH BENADRYL IV AND PO AS WELL AS IV STEROIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER OTW SIROLIMUS-ELUTING CORONARY STENT NIQ CORDIS CORP CWS13300 3.00 X 13 MM A0304585

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization PT ON VERAPAMIL