BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZUMA ZM6F (JL4.0)

    MDR report key: 385662 · Received March 29, 2002

    Report

    Report Number
    1220452-2002-00034
    Event Type
    Death
    Date Received
    March 29, 2002
    Date of Event
    February 5, 2002
    Report Date
    March 20, 2002
    Manufacturer
    MEDTRONIC AVE, INC.
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO THE CO THAT A PT EXPIRED DURING AN ATTEMPTED CORONARY STENTING PROCEDURE. HEART CATH PROCEDURE BEGAN AND A 6.5 FR, SHEATH WAS INTRODUCED INTO THE ARTERY. PROCEEDED TO PREPARE FOR PTCA. PT BEGAN TO COMPLAIN OF BACK PAIN. PT MEDICATED FOR PAIN WITH DILAUDED 1MGM IVP. WHILE MEDICATION BEING ADMINISTERED THE LEFT CORONARY GUIDE CATHETER WAS INTRODUCED INTO THE LEFT MAIN AND THE PT BEGAN TO COMPLAIN OF CHEST PAIN. THE PT IMMEDIATELY BECAME SYMPTOMATIC, WITH B/P DROPPING 96/52. THE PT BECAME UNRESPONSIVE AND A "CODE BLUE/MEDIC" WAS CALLED. MULTIPLE MEDICATIONS INCLUDING EPINEPHRINE 1 MGM TIME 3, SODIUM BICARBONATE 1 AMP, ATROPINE 1 MGM TIMES 2, LIDOCAINE 100 MGM IVP, LIDOCAINE DRIP WERE ADMINISTERED. DEATH WAS PRONOUNCED. CAUSE OF DEATH LISTED AS SUDDEN OCCLUSION OF LEFT MAIN ARTERY AND MYOCARDIAL INFARCTION. PER HOSP REPORT: NO INDICATION THIS PT'S DEATH IS RELATED TO EQUIPMENT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZUMA ZM6F (JL4.0) GUIDE CATHETER DQY MEDTRONIC AVE, INC. NA 101357

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death