BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 8343572 · Received February 15, 2019

    Report

    Report Number
    3008642652-2019-01157
    Event Type
    Death
    Date Received
    February 15, 2019
    Date of Event
    January 16, 2019
    Report Date
    February 14, 2019
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. DURING THE INCOMING FUNCTIONAL TESTING, A 1HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE ECG ELECTRODES, FOLLOWED BY A 5HZ SIMULATED TREATABLE ARRHYTHMIA SIGNAL WHICH VERIFIED PROPER PERFORMANCE OF THE DETECTION ALGORITHM. DURING THE TRANSITION TO THE 5HZ SIGNAL, THE DEVICE WAS CONFIRMED TO PROPERLY ENTER INTO A TREATMENT SEQUENCE WHICH INCLUDES A VERIFICATION OF THE TACTILE VIBRATION ALARM, AUDIO MESSAGING, AND SIREN ALARMS, AS WELL AS A TEST OF THE PULSE DELIVERY CIRCUITRY. THE PULSE DELIVERY CIRCUITRY TEST VERIFIED PROPER CHARGING OF THE HIGH VOLTAGE CAPACITORS AND PROPER DELIVERY OF FIVE FULL ENERGY 150J BIPHASIC PULSES. THE FUNCTIONAL TESTING CONFIRMED PROPER RESPONSE BUTTON FUNCTIONALITY, ECG ACQUISITION, DETECTION ALGORITHM PERFORMANCE, AND PULSE DELIVERY FUNCTIONALITY. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. MANUFACTURE DATES: MONITOR: 7/21/2015, BELT: 5/19/2011.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY ON (B)(6) 2019 WHILE WEARING THE LIFEVEST. THE PATIENT WAS REPORTEDLY AT HOME AND UNCONSCIOUS PRIOR TO PASSING. THE PATIENT'S DAUGHTER AND EMS WERE PRESENT FOR THE EVENT. PRIOR TO PASSING, BETWEEN 3:10:37 PM AND 4:28:30 PM THE PATIENT RECEIVED 14 APPROPRIATE TREATMENTS DURING VT OR VF AND ONE INAPPROPRIATE TREATMENT DURING ASYSTOLE. NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) CONTRIBUTED TO THE FALSE DETECTION THE LED TO THE INAPPROPRIATE TREATMENT. THE RHYTHM AT THE TIME OF THE 12TH TREATMENT WAS VENTRICULAR FIBRILLATION (VF) AND THE POST-SHOCK RHYTHM WAS ASYSTOLE FOR 45 SECONDS WITH INTERMITTENT CARDIAC ACTIVITY AND RECURRENT VT AT 250 BPM. AFTER THE FINAL TREATMENT WAS DELIVERED, THE PATIENT'S ECG SHOWS THAT THE PATIENT'S RHYTHM WAS VT AT 230 BPM WITH VARIABLE HEART RATE, AND ASYSTOLE AT 4:33:15 PM AND 4:38:15 PM. CPR ARTIFACT IS SEEN ON PATIENT'S ECG AT 4:44:03 PM. AT 4:45:16 PM AND 4:48:36, ARRHYTHMIAS WERE DETECTED. THE RESPONSE BUTTONS WERE PRESSED DURING THESE ARRHYTHMIAS. THE PATIENT'S ECG SHOWS THAT THE PATIENT'S RHYTHM WAS VF WITH CPR ARTIFACT. AT 4:51:59 PM, A NON-TREATABLE RHYTHM WAS DECLARED. THE ECG SHOWS THAT THE PATIENT'S RHYTHM WAS IDIOVENTRICULAR RHYTHM AT 70 TO 90 BPM WITH MOTION ARTIFACT. AT 5:01:04 PM, THE PATIENT'S ELECTRODE BELT WAS DISCONNECTED. THE PATIENT'S RHYTHM AT THE TIME OF DISCONNECTION WAS OBSCURED BY MOTION ARTIFACT. VARYING HEARTRATE, ASYSTOLE, CPR ARTIFACT, AND RESPONSE BUTTON USAGE PREVENTED THE LIFEVEST FROM DELIVERING A TREATMENT FROM 4:33:15 PM UNTIL THE ELECTRODE BELT WAS DISCONNECTED. THE PATIENT'S EQUIPMENT WAS RETURNED AND WAS FOUND TO BE FULLY FUNCTIONAL. THERE IS NO INDICATION THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139133 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death| O