BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 11903308 · Received May 28, 2021

    Report

    Report Number
    3008642652-2021-04539
    Event Type
    Death
    Date Received
    May 28, 2021
    Date of Event
    April 1, 2021
    Report Date
    May 26, 2021
    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. 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 1 HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE ECG ELECTRODES, FOLLOWED BY A 5 HZ SIMULATED TREATABLE ARRHYTHMIA SIGNAL WHICH VERIFIED PROPER PERFORMANCE OF THE DETECTION ALGORITHM. DURING THE TRANSITION TO THE 5 HZ 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. DEVICE MANUFACTURE DATE: MONITOR: 08/12/2016, BELT: 04/25/2013.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY WHILE WEARING THE LIFEVEST ON (B)(6) 2021. IT WAS REPORTED THAT PARAMEDICS ARRIVED AND REMOVED THE LIFEVEST. PER CLINICAL REVIEW OF THE CONTINUOUS ECG RECORDING, THE DEVICE WAS STARTED UP AT 07:40:47 ON (B)(6) 2021. AT 12:05:58 THE PATIENT WAS IN SINUS BRADYCARDIA AT 50 BPM, WHICH TRANSITIONED TO VT AT 110 BPM BEFORE DEGRADING TO VF. THE FUNDAMENTAL FREQUENCY OF THE VF WAS LESS THAN THE PHYSICIAN PRESCRIBED RATE THRESHOLD OF 3.33 HZ (200 BPM), PREVENTING THE LIFEVEST FROM DETECTING THE ARRHYTHMIA. THE LIFEVEST DETECTED THE VF ARRHYTHMIA FROM 12:06:00 TO 12:07:11, BUT RESPONSE BUTTON USE PREVENTED THE LIFEVEST FROM DELIVERING A TREATMENT. IT WAS NOT REPORTED WHO WAS PRESSING THE RESPONSE BUTTONS. THE PATIENT'S RHYTHM THEN DEGRADED TO ASYSTOLE. THE PATIENT WAS IN ASYSTOLE WITH CPR/MOTION ARTIFACT, WHICH DEGRADED TO VF WITH CPR/MOTION ARTIFACT AT APPROXIMATELY 12:34:50. CPR/MOTION ARTIFACT PREVENTED THE LIFEVEST FROM DETECTING THE ARRHYTHMIA. THE PATIENT WAS IN VF FOR APPROXIMATELY 8 MINUTES BEFORE RECEIVING A NON-LIFEVEST DEFIBRILLATION AT 12:44:00. THE PATIENT'S RHYTHM AT THE TIME OF THE FIRST NON-LIFEVEST DEFIBRILLATION WAS VF WITH CPR/MOTION ARTIFACT. THE PATIENT'S POST-SHOCK RHYTHM WAS BRADYCARDIA AT 30 BPM WITH CPR/MOTION ARTIFACT. THE PATIENT'S RHYTHM DEGRADED TO VF WITH CPR/MOTION ARTIFACT AT APPROXIMATELY 12:47:47. CPR/MOTION ARTIFACT PREVENTED THE LIFEVEST FROM DETECTING THE ARRHYTHMIA. THE PATIENT RECEIVED A SECOND NON-LIFEVEST DEFIBRILLATION AT APPROXIMATELY 12:48:12. THE PATIENT'S RHYTHM AT THE TIME OF THE SECOND NON-LIFEVEST DEFIBRILLATION WAS VF WITH CPR/MOTION ARTIFACT. THE PATIENT'S POST-SHOCK RHYTHM WAS SINUS BRADYCARDIA AT 40 BPM WITH CPR/MOTION ARTIFACT. THE PATIENT WAS IN SINUS RHYTHM/SINUS TACHYCARDIA FROM 90 TO 140 BPM WITH PVC'S AND CPR/MOTION ARTIFACT UNTIL 12:49:17. THE LIFEVEST DETECTED AN ARRHYTHMIA WHILE THE PATIENT WAS IN VT AT 150 BPM WITH MOTION ARTIFACT AT 12:50:09. THE PATIENT RECEIVED A THIRD NON-LIFEVEST DEFIBRILLATION AT APPROXIMATELY 12:50:24. THE PATIENT'S RHYTHM AT THE TIME OF THE NON-LIFEVEST DEFIBRILLATION WAS VT AT 150 BPM WITH MOTION ARTIFACT/ELECTRODE LEAD FALL OFF. THE PATIENT'S POST-SHOCK RHYTHM WAS AN IDIOVENTRICULAR RHYTHM AT 70 BPM WITH MOTION ARTIFACT/ELECTRODE LEAD FALL OFF. THE LIFEVEST PROPERLY DETECTED THE VT ARRHYTHMIA, BUT THE NON-LIFEVEST DEFIBRILLATION WAS DELIVERED APPROXIMATELY 15 SECONDS INTO THE DETECTION SEQUENCE, PREVENTING THE LIFEVEST FROM TREATING THE VT ARRHYTHMIA. THE PATIENT WAS IN SINUS TACHYCARDIA/AN IDIOVENTRICULAR RHYTHM AT 100 BPM, WHICH SLOWED TO AN IDIOVENTRICULAR RHYTHM AT 60 BPM WITH CPR/MOTION ARTIFACT AT APPROXIMATELY 12:52:52. THE PATIENT'S RHYTHM THEN DEGRADED TO ASYSTOLE WITH CPR/MOTION ARTIFACT AT APPROXIMATELY 13:02:20. THE PATIENT WAS IN ASYSTOLE WITH CPR/MOTION ARTIFACT AT THE TIME OF THE ELECTRODE BELT DISCONNECTION AT 13:09:15. IT WAS REPORTED THAT PARAMEDICS DISCONNECTED THE ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797447 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 Death