BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 11608447 · Received April 2, 2021

    Report

    Report Number
    3008642652-2021-02898
    Event Type
    Death
    Date Received
    April 2, 2021
    Date of Event
    February 26, 2021
    Report Date
    April 2, 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. 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. MANUFACTURE DATES: MONITOR: 5/11/2015, ELECTRODE BELT: 2/25/2011.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY ON (B)(6) 2021 WHILE WEARING THE LIFEVEST. IT WAS REPORTED THAT THE PATIENT'S DAUGHTER FOUND THE PATIENT DECEASED. REVIEW OF THE PATIENT'S DOWNLOAD DATA REVEALED THAT PRIOR TO PASSING, THE PATIENT RECEIVED TWO INAPPROPRIATE TREATMENTS FROM THE LIFEVEST. AT 7:23:11, THE PATIENT RECEIVED THE FIRST TREATMENT. THE PATIENT'S RHYTHM AT THE TIME OF THE TREATMENT WAS AN IDIOVENTRICULAR RHYTHM AT 10 BPM, AND THE POST-SHOCK RHYTHM WAS ALSO AN IDIOVENTRICULAR RHYTHM AT 10 BPM. THE PATIENT REMAINED IN IDIOVENTRICULAR RHYTHM AT 10 BPM FROM 7:23:58 TO 8:07:18. THE PATIENT'S RHYTHM THEN DEGRADED TO ASYSTOLE. AT 10:02:29, THE PATIENT RECEIVED THE SECOND TREATMENT FROM THE LIFEVEST. THE PATIENT'S RHYTHM AT THE TIME OF THE TREATMENT WAS ASYSTOLE, AND THE POST-SHOCK RHYTHM WAS ASYSTOLE. THE PATIENT REMAINED IN ASYSTOLE UNTIL THE DEVICE WAS SHUTDOWN AT 10:21:38. OVERSENSING OF LOW AMPLITUDE CARDIAC ACTIVITY CONTRIBUTED TO THE FALSE DETECTION. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE EVENT. THERE IS NO INDICATION THAT THE LIFEVEST CAUSED OR CONTRIBUTED TO THE PATIENT'S PASSING AS THE PATIENT WAS IN A NON-LIFE-SUSTAINING RHYTHM AT THE TIME OF BOTH TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507343 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O