BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 9385679 · Received November 27, 2019

    Report

    Report Number
    3008642652-2019-09626
    Event Type
    Death
    Date Received
    November 27, 2019
    Date of Event
    October 16, 2019
    Report Date
    November 27, 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. 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: 8/15/2014 ELECTRODE BELT: 4/242015.

    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. IT WAS REPORTED THAT THE PATIENT WAS AT HOME AND HIS WIFE WAS PRESENT AT THE TIME OF PASSING. REVIEW OF THE DOWNLOAD DATA REVEALED THAT THE PATIENT RECEIVED 2 TREATMENT SHOCKS ON THE DAY OF PASSING. AT 7:43:16 AM, THE PATIENT RECEIVED AN APPROPRIATE TREATMENT. THE PATIENT'S RHYTHM AT THE TIME OF THE TREATMENT WAS VF AND THE POST-SHOCK RHYTHM WAS AF AT 30 BPM WITH PVCS. AT 7:43:47 AM, THE PATIENT RECEIVED AN INAPPROPRIATE TREATMENT. THE PATIENT'S RHYTHM AT THE TIME OF THE TREATMENT WAS AF AT 30 BPM WITH PVCS WITH MOTION ARTIFACT AND AMPLITUDE OVERSENSING. MOTION ARTIFACT AND AMPLITUDE OVERSENSING CONTRIBUTED TO THE FALSE DETECTION. THE RESPONSE BUTTONS WERE PRESSED AFTER THE SECOND TREATMENT WAS DELIVERED. AT 7:43:58 AM, AN ARRHYTHMIA WAS DETECTED WITH RESPONSE BUTTON USE. IT IS UNKNOWN WHO WAS PRESSING THE RESPONSE BUTTONS. THE PATIENT'S RHYTHM AT THE TIME OF THE DETECTED ARRHYTHMIA WAS BRADYCARDIA AT 30 BPM WITH NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) DEGRADING VENTRICULAR FIBRILLATION (VF). FROM 7:43:47 AM UNTIL THE ELECTRODE BELT WAS DISCONNECTED AT 8:09:31 AM, THE PATIENT'S RHYTHM WAS SINUS RHYTHM AT 90 BPM SLOWING TO BRADYCARDIA AT 30 BPM WITH PVC'S AND NSVT DEGRADING TO VF WITH MOTION ARTIFACT AND RESPONSE BUTTON USE. THE RESPONSE BUTTON USE DURING THIS TIME PREVENTED THE LIFEVEST FROM DELIVERING A TREATMENT DURING THIS TIME. IT IS UNKNOWN WHO WAS PRESSING THE RESPONSE BUTTONS DURING THIS TIME. THE ELECTRODE BELT WAS DISCONNECTED AT 8:09:31 AM. EMS WAS CALLED DURING THE EVENT. THE PATIENT'S EQUIPMENT WAS RETURNED AND WAS FOUND TO BE FULLY FUNCTIONAL. THERE IS NO INDICATION THAT A DEVICE MALFUNCTION THAT CAUSED OR CONTRIBUTED TO THE PATIENT'S PASSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178717 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death| O