BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 9364023 · Received November 22, 2019

    Report

    Report Number
    3008642652-2019-09481
    Event Type
    Death
    Date Received
    November 22, 2019
    Date of Event
    October 15, 2019
    Report Date
    November 22, 2019
    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: 3/15/2012, BELT: 3/21/2013.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY ON (B)(6) 2019, WHILE WEARING THE LIFEVEST. THE PATIENT WAS REPORTEDLY IN THE HOSPITAL AND ON TELEMETRY PRIOR TO PASSING. THE HOSPITAL STAFF PERFORMED RESUSCITATION EFFORTS. PER CLINICAL REVIEW OF THE AVAILABLE ECG DATA, THE DEVICE WAS STARTED UP AT 14:19:20 ON (B)(6) 2019. A DIAGNOSTIC MANUAL RECORDING WAS TAKEN AT 14:50:10, WHILE THE PATIENT WAS IN AN IDIOVENTRICULAR RHYTHM AT 60 BPM. THE DEVICE DETECTED SYSTOLE FIVE TIMES FROM 15:14:52 TO 15:32:51, WHILE THE PATIENT WAS IN AN IDIOVENTRICULAR RHYTHM AT 60 BPM WITH PVC'S. THE DEVICE WAS SHUTDOWN AT 15:37:28 ON (B)(6) 2019. THE DEVICE WAS RESTARTED AT 15:38:11 ON (B)(6) 2019. TWO MANUAL RECORDINGS WERE TAKEN FROM 14:11:48 TO 14:24:13 WITH RB USE ON 10/15/2019, WHILE THE PATIENT WAS IN A PACED RHYTHM AT 60 BPM WITH PVC'S. THE DEVICE WAS SHUTDOWN AT 14:51:05 ON (B)(6) 2019. THE DEVICE WAS RESTARTED AT 14:51:55 ON (B)(6) 2019. THE DEVICE DETECTED ASYSTOLE AT 18:53:32. WHILE THE PATIENT WAS IN A PACED RHYTHM AT 60 BPM DEGRADING TO VT AT 130 BPM DEGRADING TO VF WITH VARIABLE AMPLITUDES AND LOW AMPLITUDE CARDIAC SIGNAL DEGRADING TO ASYSTOLE. THE DEVICE DETECTED AN ARRHYTHMIA AT 18:53:40, WHILE THE PATIENT WAS IN ASYSTOLE WITH PACEMAKER SPIKES AND CPR ARTIFACT. THE DEVICE DETECTED ASYSTOLE AT 18:54:26, WHILE THE PATIENT WAS IN ASYSTOLE WITH PACEMAKER SPIKES. THE DEVICE DETECTED AN ARRHYTHMIA 18:55:00 WITH RB USE WHILE THE PATIENT WAS IN ASYSTOLE WITH PACEMAKER SPIKES AND CPR ARTIFACT. IT IS UNCLEAR WHO WAS PRESSING THE RESPONSE BUTTONS. THE ELECTRODE BELT WAS DISCONNECTED AT 18:55:51 ON (B)(6) 2019, WHILE THE PATIENT WAS IN ASYSTOLE WITH CPR/MOTION ARTIFACT. THE DEVICE PROPERLY DETECTED VT/VF. HOWEVER, VARIABLE AMPLITUDES, LOW AMPLITUDE CARDIAC SIGNAL AND THE PATIENT'S HEART RATE FALLING BELOW THE TREATMENT THRESHOLD PREVENTED THE LIFEVEST FROM TREATING THE PATIENT. THE PATIENT WAS REPORTEDLY IN THE HOSPITAL, ON HOSPITAL TELEMETRY, AND UNDER MENDICAL CARE AT THE TIME OF PASSING. IT WAS REPORTED THAT HOSPITAL STAFF PERFORMED RESUSCITATION EFFORTS. THE PATIENT'S EQUIPMENT WAS RETURNED AND WAS FOUND TO BE FULLY FUNCTIONAL. THERE IS NO INDICATION THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1156515 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death