BEUDAMED
    FDA Adverse Event Death Summary report: N

    CYPHER CLINICAL 2.5 X 23MM

    MDR report key: 587862 · Received April 1, 2005

    Report

    Report Number
    9610978-2005-01307
    Event Type
    Death
    Date Received
    April 1, 2005
    Date of Event
    January 1, 2005
    Report Date
    April 1, 2005
    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

    THE PT FELL UNCONSCIOUS WHILE DANCING. UPON ARRIVAL OF THE EMERGENCY TEAM, THE PT WAS FOUND TO BE ASYSTOLIC. CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. THE PT WAS INTUBATED,, INTERVENOUS (IV) ACCESS WAS ESTABLISHED, ADRENALINE 10 MG, ATROPINE 3 MG, AND BICARBONATE WERE ADMINISTERED. THE PT WAS STILL ASYSTOLIC. CPR WAS CONTINUED, AND THE PT WAS TRANSFERRED TO THE HOSP. THE PT EXPIRED SHORTLY AFTER ARRIVAL TO THE HOSP. TOTAL CPR TIME WAS REPORTED TO BE APPROXIMATELY 30 MINUTES. THE OFFICIAL CAUSE OF DEATH WAS REPORTED TO BE ASYSTOLE. NO AUTOPSY WAS PERFORMED. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER CLINICAL 2.5 X 23MM DRUG-ELUTING STENT NIQ CORDIS EUROPA, N.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death| H| L| R