BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 11517708 · Received March 18, 2021

    Report

    Report Number
    3008642652-2021-02391
    Event Type
    Death
    Date Received
    March 18, 2021
    Date of Event
    February 7, 2021
    Report Date
    March 16, 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 REPORTED PROBLEM (PATIENT DEATH) WAS CONFIRMED. 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. DEVICE MANUFACTURE DATE: MONITOR 10/17/2012, BELT 02/09/2012.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT HAD PASSED AWAY AT HOME WHILE WEARING THE LIFEVEST ON (B)(6) 2021. REVIEW OF THE DOWNLOAD DATA INDICATES THE PATIENT RECEIVED TWO INAPPROPRIATE TREATMENTS ON THE DAY OF PASSING. PER CLINICAL REVIEW OF THE CONTINUOUS ECG RECORDINGS, THE DEVICE WAS STARTED UP AT 06:29:36 ON (B)(6) 2021. THE PATIENT WAS IN A SINUS RHYTHM AT 75 TO 100 BPM WITH PVC'S UNTIL THE ONSET OF VT AT 21:47:21. AN ARRHYTHMIA WAS DETECTED AT 21:47:25 WHILE THE PATIENT WAS IN VT AT 300 BPM WITH MOTION ARTIFACT. THE PATIENT'S RHYTHM TRANSITIONED TO VF WITH MOTION ARTIFACT AT 21:47:56. THE DEVICE PROPERLY DETECTED VT/VF, HOWEVER MOTION ARTIFACT PREVENTED THE LIFEVEST FROM DELIVERING A TREATMENT. AN ARRHYTHMIA WAS DETECTED AT 21:48:07 WHILE THE PATIENT WAS IN VF. THE PATIENT RECEIVED THE FIRST APPROPRIATE TREATMENT AT 21:48:41. THE PATIENT'S RHYTHM AT THE TIME OF THE TREATMENT WAS VF. THE PATIENT'S POST-SHOCK RHYTHM WAS AN IDIOVENTRICULAR RHYTHM AT 30 BPM. THE PATIENT WAS IN AN IDIOVENTRICULAR RHYTHM AT 30 BPM THAT GRADUALLY SLOWED TO 20 BPM UNTIL THE ONSET OF VT AT 22:18:34. AN ARRHYTHMIA WAS DETECTED AT 22:18:43 WHILE THE PATIENT WAS IN VT AT 170 BPM. THE PATIENT RECEIVED THE SECOND APPROPRIATE TREATMENT, WHICH FAILED TO CONVERT THE ARRHYTHMIA, AT 22:19:49. THE PATIENT'S RHYTHM AT THE TIME OF THE TREATMENT WAS VF. THE PATIENT'S POST-SHOCK RHYTHM WAS ALSO VF. AT 22:21:18 THE PATIENT WAS IN VF WITH LOW AMPLITUDE IN THE ASYSTOLE DETECTION RANGE. THE LOW AMPLITUDE PREVENTED THE LIFEVEST FROM DETECTING THE TREATABLE ARRHYTHMIA. THE DEVICE THRESHOLD FOR DETECTION OF CARDIAC SIGNALS IS 100 MICROVOLTS. THIS PERFORMANCE LEVEL IS DISCLOSED IN THE LIFEVEST 4000 OPERATORS MANUAL. THE CARDIAC SIGNAL VOLTAGE OBSERVED WAS BELOW 100 MICROVOLTS, WHICH IS UNDER THE MINIMUM DESIGN REQUIREMENT TO DETERMINE THE PRESENCE OF CARDIAC SIGNALS. THE PATIENT'S RHYTHM THEN TRANSITIONED TO ASYSTOLE WITH OCCASIONAL CARDIAC ACTIVITY AT APPROXIMATELY 22:27:08. THE PATIENT WAS IN ASYSTOLE UNTIL THE DEVICE WAS SHUTDOWN AT 05:16:30 ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417666 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death