BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER DRUG-ELUTING STENT

    MDR report key: 5866311 · Received January 14, 2004

    Report

    Report Number
    5866311
    Event Type
    Death
    Date Received
    January 14, 2004
    Date of Event
    November 20, 2003
    Report Date
    November 20, 2003
    Manufacturer
    JOHNSON AND JOHNSON HEALTHCARE
    Product Code
    NIQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD CARDIAC CATHETERIZATION ON (B)(6) 2003 WHICH INDICATED NEED FOR INTERVENTION. INTERVENTIONAL CATHETERIZATION PERFORMED ON (B)(6) 2003 PER DR (B)(6). CYPHER DRUG-ELUTING STENT (B)(4) USED IN PROCEDURE. ANGIOMAX INFUSED DURING CARE. DOCUMENTATION STATES PATIENT PAIN FREE, NO HEMATOMA, ANGIOSEAL USED. ON 17:08 - 154/81, RR 22, HR 68, SPO2 96 PERCENT. ON (B)(6) 2003 PATIENT ARRIVES EMERGENTLY AS DIRECT ADMIT FROM DR. (B)(6)'S OFFICE AT 12:26 PM. PATIENT COMPLAINS OF LEFT SHOULDER AND CHEST PAIN, RATING 4-5/10 ON PAIN SCALE. VITAL SIGNS ON ARRIVAL TO LAB - SPO2 76 PERCENT. O2 2 LITERS/NASAL CANNULA APPLIED, SPO2 92 PERCENT; HR 100, BP 127/91, RR 21. CARDIAC CATHETERIZATION/INTERVENTION PERFORMED PER DR (B)(6). INTEGRILLIN ADMINISTERED DURING PROCEDURE. POST-PROCEDURE VITAL SIGNS: SPO2 96 PERCENT, HR 91, BP 140/82, RR 19. PT COMPLAINS OF L SHOULDER PAIN, RATING 2/10. MORPHINE GIVEN - 4 MINUTES DENIES PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER DRUG-ELUTING STENT STENT NIQ JOHNSON AND JOHNSON HEALTHCARE A1003422 SIZE 3.0X18

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death