BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 12715184 · Received October 28, 2021

    Report

    Report Number
    3008642652-2021-09517
    Event Type
    Death
    Date Received
    October 28, 2021
    Date of Event
    September 21, 2021
    Report Date
    October 27, 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 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 NOT BEEN RECOVERED. THE DEVICE FLAG DATA FROM THE LAST DOWNLOAD ((B)(6) 2021) DOES NOT INDICATE ANY DEVICE MALFUNCTION. THE REVIEW OF THE DATA INDICATED THAT THE DEVICE POWERED ON NORMALLY AND WAS ABLE TO ACQUIRE THE PATIENT'S ECG SIGNAL ON THE LAST DAY OF USE CAPTURED IN THE DATA DOWNLOAD. NO DEFICIENCIES ALLEGED. DEVICE MANUFACTURE DATE: MONITOR 05/14/2020; BELT 10/09/2017.

    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. PER CLINICAL REVIEW OF THE CONTINUOUS ECG RECORDING, THE DEVICE WAS STARTED UP AT 03:08:19 ON (B)(6) 2021. THE PATIENT WAS IN AN IDIOVENTRICULAR RHYTHM AT 40 BPM AT 14:15:00, WHICH DEGRADED TO ASYSTOLE. THE PATIENT'S RHYTHM TRANSITIONED TO AN IDIOVENTRICULAR RHYTHM FROM 30 TO 80 BPM WITH CPR/MOTION ARTIFACT AT APPROXIMATELY 14:15:47. THE PATIENT'S RHYTHM DEGRADED TO VT AT 120 BPM WITH CPR/MOTION ARTIFACT AT 14:25:00, BEFORE SLOWING TO AN IDIOVENTRICULAR RHYTHM AT 30 BPM WITH NSVT AND CPR/MOTION ARTIFACT AT 14:25:35. THE VT ARRHYTHMIA SELF-CONVERTING TO AN IDIOVENTRICULAR RHYTHM PREVENTED THE LIFEVEST FROM DETECTING THE ARRHYTHMIA. THE LIFEVEST TYPICALLY REQUIRES 60 SECONDS OF SUSTAINED VT TO DELIVER A TREATMENT SHOCK. THE PATIENT WAS IN AN IDIOVENTRICULAR RHYTHM AT 60 BPM WITH BBB, PVC'S, AND CPR/MOTION ARTIFACT. THE PATIENT'S RHYTHM THEN DEGRADED TO VT FROM 220 TO 270 BPM WITH VARYING HEART RATE, ELECTRODE LEAD FALL OFF, AND CPR/MOTION ARTIFACT AT 14:27:55. THE LIFEVEST DETECTED THE VT ARRHYTHMIA, BUT CPR/MOTION ARTIFACT PREVENTED THE LIFEVEST FROM DELIVERING A TREATMENT SHOCK. THE PATIENT RECEIVED AN EXTERNAL DEFIBRILLATION AT 14:29:20. THE PATIENT'S RHYTHM AT THE TIME OF THE EXTERNAL DEFIBRILLATION WAS VT AT 220 BPM WITH CPR/MOTION ARTIFACT. THE PATIENT'S POST-SHOCK RHYTHM WAS AN IDIOVENTRICULAR RHYTHM AT 40 BPM WITH PVC'S AND CPR/MOTION ARTIFACT. THE PATIENT WAS IN A PACED RHYTHM/IDIOVENTRICULAR RHYTHM WITH CPR/MOTION ARTIFACT AT APPROXIMATELY 14:29:42. THE PATIENT'S RHYTHM THEN DEGRADED TO ASYSTOLE FROM APPROXIMATELY 14:41:17 UNTIL THE ELECTRODE BELT DISCONNECTION AT 14:41:33.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1612482 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 Death