BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 16994478 · Received May 24, 2023

    Report

    Report Number
    3008642652-2023-05201
    Event Type
    Death
    Date Received
    May 24, 2023
    Date of Event
    December 30, 2022
    Report Date
    May 24, 2023
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION OF THE MONITOR AND ELECTRODE BELT HAS BEEN COMPLETED. THE EVALUATION INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAY OF THE EVENT AND INCOMING FUNCTIONAL TESTING. 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 PATIENT RECEIVED THREE APPROPRIATE TREATMENTS, ONE WHICH CONVERTED THE ARRHYTHMIA, ONE WHICH DID NOT CONVERT THE ARRHYTHMIA, AND ONE WHICH RESULTED IN POST SHOCK ASYSTOLE. THE PATIENT ALSO RECEIVED FOUR INAPPROPRIATE TREATMENTS AND ONE NON-LIFEVEST DEFIBRILLATION. THE DEVICE WAS STARTED UP AT 09:38:55 ON (B)(6) 2022. AT 13:19:46, AN ARRHYTHMIA WAS DETECTED. ECG SHOWS SINUS RHYTHM @ 80 BPM WITH PVC¿S. THE RHYTHM THEN DEGRADED TO VF. AT 13:20:22, THE PATIENT RECEIVED THE FIRST APPROPRIATE TREATMENT. THE RHYTHM AT THE TIME OF TREATMENT WAS VF. POST SHOCK RHYTHM WAS SINUS BRADYCARDIA @ 40 BPM WITH PVC¿S. AT 13:21:34, AN ARRHYTHMIA WAS DETECTED. ECG SHOWS VF. AT 13:22:05, THE PATIENT RECEIVED THE SECOND APPROPRIATE TREATMENT. THE RHYTHM AT THE TIME OF TREATMENT WAS VF. POST SHOCK RHYTHM WAS WITH INTERMITTENT CARDIAC ACTIVITY. POST-SHOCK ASYSTOLE IS A KNOWN AND POTENTIALLY ADVERSE OUTCOME OF DEFIBRILLATION THERAPY. AT 13:22:37, THE PATIENT RECEIVED THE FIRST INAPPROPRIATE TREATMENT. OVERSENSING OF CARDIAC ACTIVITY CONTRIBUTED TO THE FALSE DETECTION. THE PATIENT WAS IN A NON-LIFE SUSTAINING RHYTHM PRIOR TO THE TREATMENT. THE RHYTHM AT THE TIME OF TREATMENT WAS ASYSTOLE WITH INTERMITTENT CARDIAC ACTIVITY. POST SHOCK RHYTHM WAS SINUS BRADYCARDIA @ 30 BPM WITH NSVT. AT 13:23:06, THE PATIENT RECEIVED THE SECOND INAPPROPRIATE TREATMENT. OVERSENSING OF CARDIAC ACTIVITY CONTRIBUTED TO THE FALSE DETECTION. THE RHYTHM AT THE TIME OF TREATMENT WAS SINUS BRADYCARDIA @ 40 BPM WITH PVC¿S. POST SHOCK RHYTHM WAS SINUS BRADYCARDIA @ 50 BPM WITH CPR/MOTION ARTIFACT AND PVC¿S. AT 13:23:33, THE PATIENT RECEIVED THE THIRD INAPPROPRIATE TREATMENT. NSVT CONTRIBUTED TO THE FALSE DETECTION. THE RHYTHM AT THE TIME OF TREATMENT WAS NSVT. POST SHOCK RHYTHM WAS SINUS BRADYCARDIA @ 40 BPM WITH CPR/MOTION ARTIFACT AND PVC¿S. AT 13:24:11, THE PATIENT RECEIVED THE FOURTH INAPPROPRIATE TREATMENT. NSVT CONTRIBUTED TO THE FALSE DETECTION. THE RHYTHM AT THE TIME OF TREATMENT WAS NSVT. POST SHOCK RHYTHM WAS VT @ 220 BPM WITH CPR/MOTION ARTIFACT. THE RHYTHM THEN DEGRADED TO VF WITH CPR/MOTION ARTIFACT AND ELECTRODE LEAD FALL OFF. AT 13:29:14, THE PATIENT RECEIVED THE NON-LIFEVEST DEFIBRILLATION. RHYTHM AT TIME OF TREATMENT WAS VF WITH CPR/MOTION ARTIFACT. POST SHOCK RHYTHM WAS ASYSTOLE WITH INTERMITTENT CARDIAC ACTIVITY. AT 13:31:25, AN ARRHYTHMIA WAS DETECTED. ECG SHOWS VF WITH CPR/MOTION ARTIFACT. AT 13:32:35, THE PATIENT RECEIVED THE THIRD APPROPRIATE TREATMENT. THE RHYTHM AT THE TIME OF TREATMENT WAS VF WITH CPR/MOTION ARTIFACT. POST SHOCK RHYTHM WAS VF WITH CPR/MOTION ARTIFACT AND ELECTRODE LEAD FALL OFF. THE ELECTRODE BELT WAS DISCONNECTED AT 14:28:08 ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897880 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death