BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 14149054 · Received April 19, 2022

    Report

    Report Number
    3008642652-2022-04082
    Event Type
    Death
    Date Received
    April 19, 2022
    Date of Event
    March 25, 2022
    Report Date
    April 19, 2022
    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 · 0

    DEVICE EVALUATION OF THE MONITOR AND ELECTRODE BELT HAVE 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.

    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 07:24:44 ON (B)(6) 2022. FROM 21:25:08 TO 21:27:17, AN ARRHYTHMIA WAS DETECTED TWO TIMES. ECG SHOWS SINUS BRADYCARDIA FROM 50-30 BPM WITH BIGEMINY AND TRIGEMINY WITH CPR/MOTION ARTIFACT. THE RHYTHM THEN DEGRADES TO ASYSTOLE. DETECTION STOPPED AT 21:27:21. AT 21:30:55, ASYSTOLE WAS DETECTED. ECG SHOWS SINUS BRADYCARDIA @ 30 BPM WITH BIGEMINY AND TRIGEMINY WITH CPR/MOTION ARTIFACT. AT 21:31:05, AN ARRHYTHMIA WAS DETECTED. ECG SHOWS ASYSTOLE WITH TRANSITIONING TO SINUS BRADYCARDIA FROM 20-10 BPM WITH BIGEMINY AND CPR/MOTION ARTIFACT. DETECTION STOPPED AT 21:31:24. AT 21:32:08, ASYSTOLE WAS DETECTED. ECG SHOWS SINUS BRADYCARDIA FROM 20-10 BPM WITH BIGEMINY AND CPR/MOTION ARTIFACT. FROM 21:36:48 TO 21:49:24, AN ARRHYTHMIA WAS DETECTED TWO TIMES. ECG SHOWS VT FROM 210-150 BPM WITH CPR/ELECTRODE LEAD FALL OFF. CPR/MOTION ARTIFACT, ELECTRODE LEAD FALL OFF, HR NOT IN DETECTION SEQUENCE LONG ENOUGH AND HR AT OR BELOW THE THRESHOLD FOR TREATMENT PREVENTED THE LIFEVEST FROM TREATING THE PATIENT. AT 21:36:48, THE PATIENT RECEIVED A NON-LIFEVEST DEFIBRILLATION. RHYTHM AT TIME OF TREATMENT WAS VT @ 150 BPM. POST SHOCK RHYTHM WAS SINUS TACHYCARDIA @ 100 BPM WITH CPR/MOTION ARTIFACT AND ELECTRODE LEAD FALL OFF. THE ELECTRODE BELT WAS DISCONNECTED AT 22:24:00 ON (B)(6) 2022. THE PATIENT PASSED AWAY ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1273649 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death