BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXIMO II VR DEFIBRILLATOR

    MDR report key: 1982443 · Received January 31, 2011

    Report

    Report Number
    1982443
    Event Type
    Death
    Date Received
    January 31, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 28, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS WAS A (B)(6) MALE WITH A PAST MEDICAL HISTORY OF CHF (EJECTION FRACTION OF 45%), TYPE 2 DIABETES, CHRONIC MYELOID LEUKEMIA, AORTIC VALVE REPAIR, CAD, RENAL INSUFFICIENCY, CHRONIC ANEMIA, HYPERTENSION AND ATRIAL FIBRILLATION. HE PRESENTED TO THE ED ON (B)(6) 2011, COMPLAINING OF LIGHTHEADEDNESS, NAUSEA AND LOW BLOOD PRESSURE, WHICH BEGAN THIS MORNING. HE WOKE UP AND WAS JUST FEELING DIZZY AND PERSISTENTLY VOMITING. EMS WAS CALLED AND UPON ARRIVAL, PT'S SYSTOLIC BP WAS IN THE 60'S. PT HAS AUTOMATIC IMPLANTABLE CARDIAC DEFIBRILLATOR (AICD) BUT DENIED NOTICING ANY AICD FIRING OR ANY CHEST PAIN. PT WAS BEING ADMITTED FOR SHOCK, WHICH WAS LIKELY DUE SECONDARILY TO CARDIOGENIC CAUSE. THE PT'S MALFUNCTIONING AICD WAS THOUGHT TO BE THE ETIOLOGY. THE MEDTRONIC AICD TECH WAS CONSULTED TO INTERROGATE THE PACER AND ALSO CARDIOLOGIST WAS CONSULTED. WHILE WAITING FOR MEDTRONIC TECH AND CARDIOLOGIST, PT WAS EXTERNALLY PACED. HIS BP INITIALLY RESPONDED WITH IMPROVED BP, BUT THIS ONLY LASTED A FEW MINUTES. UPON ARRIVAL, MEDTRONIC TECH CONFIRMED AICD WAS NOT FUNCTIONING PROPERLY. ATTEMPTED TO PLACE TRANSVENOUS PACER, BUT THIS DID NOT CAPTURE EITHER. PT BECAME ASYSTOLIC AT THIS POINT AND CPR WAS STARTED. PT EXPIRED AT 21:52 ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO II VR DEFIBRILLATOR MEDTRONIC CARDIOVASCULAR LWS MEDTRONIC CARDIOVASCULAR D284VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death MODEL# 693558| SERIAL# (B)(4)