BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 15277241 · Received August 23, 2022

    Report

    Report Number
    3008642652-2022-22646
    Event Type
    Death
    Date Received
    August 23, 2022
    Date of Event
    July 10, 2022
    Report Date
    August 23, 2022
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION OF THE MONITOR 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. THE ELECTRODE BELT HAS BEEN RETURNED AND THE EVALUATION IS UNDERWAY. THE DEVICE FLAG DATA FROM THE LAST DOWNLOAD DOES NOT INDICATE ANY DEVICE MALFUNCTION.

    Description of Event or Problem · 0

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY ON (B)(6) 2022 WHILE REPORTEDLY WEARING THE LIFEVEST.   THE DEVICE WAS STARTED UP AT 16:51:01 ON (B)(6) 2022. FROM 21:43:26 TO 21:43:38, AN ARRHYTHMIA WAS DETECTED THREE TIMES. ECG SHOWS IDIOVENTRICULAR RHYTHM @ 20 BPM WITH PVC¿S. THE RHYTHM THEN DEGRADES TO VT @ 200-260 BPM WITH VARYING HEART RATE. THE RHYTHM THEN SLOW TO VT @ 200 BPM DEGRADING TO FINE VF. DETECTION STOPPED AT 21:43:40. THE DEVICE PROPERLY DETECTED VT/VF. HOWEVER, VARYING HEART RATE AMPLITUDES AND LOW AMPLITUDE CARDIAC SIGNAL PREVENTED THE LIFEVEST FROM TREATING THE PATIENT. FROM 21:45:12 TO 21:06, ASYSTOLE WAS DETECTED FIVE TIMES. ECG SHOWS FINE VF DEGRADING TO ASYSTOLE WITH INTERMITTENT CARDIAC ACTIVITY. VF WAS DETECTED DURING ASYSTOLE. HOWEVER, VF FREQUENCY WAS LESS THAN THE RATE THRESHOLD. THE ELECTRODE BELT WAS DISCONNECTED AT 22:24:59 ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2594995 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death