BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 12720907 · Received October 29, 2021

    Report

    Report Number
    3008642652-2021-09561
    Event Type
    Death
    Date Received
    October 29, 2021
    Date of Event
    September 29, 2021
    Report Date
    October 29, 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 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. THE ELECTRODE BELT HAS BEEN RETURNED TO ZMC AND THE EVALUATION IS UNDERWAY. THE DEVICE FLAG DATA FROM THE LAST DOWNLOAD (10/25/2021) 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: 02/13/2018, BELT: 05/19/2014.

    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. REVIEW OF THE PATIENT'S DOWNLOAD DATA INDICATES THE PATIENT RECEIVED ONE INAPPROPRIATE SHOCK IN RESPONSE TO OVERSENSING OF LOW AMPLITUDE CARDIAC SIGNAL ON THE DATE OF PASSING. THE DEVICE WAS STARTED UP AT 09:33:32 ON (B)(6) 2021. THE PATIENT WAS IN SINUS BRADYCARDIA AT 50 BPM WITH MOTION ARTIFACT AT 22:41:35. THE PATIENT'S RHYTHM THEN DEGRADED TO ASYSTOLE. THE PATIENT WAS IN ASYSTOLE WITH INTERMITTENT CARDIAC ACTIVITY AND MOTION ARTIFACT AT 22:42:24. THE PATIENT RECEIVED THE INAPPROPRIATE SHOCK AT 22:45:05. THE PATIENT'S RHYTHM AT THE TIME OF THE SHOCK AND POST-SHOCK RHYTHM WERE ASYSTOLE WITH MOTION ARTIFACT. THE PATIENT WAS LAST SEEN IN ASYSTOLE WITH INTERMITTENT CARDIAC ACTIVITY AND MOTION ARTIFACT BETWEEN 22:59:33 AND 23:02:31. THE DEVICE WAS SHUTDOWN AT 23:06:31.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1620362 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 Death