BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 10270928 · Received July 14, 2020

    Report

    Report Number
    3008642652-2020-05810
    Event Type
    Death
    Date Received
    July 14, 2020
    Date of Event
    April 15, 2020
    Report Date
    July 14, 2020
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 2/6/2018, ELECTRODE BELT 7/25/2013.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY ON (B)(6) 2020 WHILE WEARING THE LIFEVEST. IT WAS REPORTED THAT THE PATIENT WAS AT HOME WITH HIS WIFE PRESENT AT THE TIME OF PASSING. IT WAS REPORTED THAT THE PATIENT'S WIFE INITIATED CPR. PER THE REVIEW OF THE PATIENT'S CONTINUOUS ECG RECORDINGS, THE PATIENT WAS IN BRADYCARDIA AT 50 BPM WITH BIGEMINY DEGRADING TO VT AT 290 BPM DEGRADING TO FINE VF WITH LOW AMPLITUDE CARDIAC SIGNAL, MOTION ARTIFACT, AND COMPLETE ELECTRODE FALLOFF ON FB CHANNELS. THE PATIENT WAS IN VT/VF FOR APPROXIMATELY 18 MINUTES, HOWEVER MOTION ARTIFACT, LOW AMPLITUDE CARDIAC SIGNAL, AND COMPLETE ELECTRODE FALLOFF ON FB CHANNELS (FB ELECTRODES WERE NOT IN PROPER CONTACT WITH THE SKIN) PREVENTED THE LIFEVEST FROM TREATING THE PATIENT FROM 01:44:54 TO 02:02:59. THE RHYTHM THEN SLOWED TO AN IDIOVENTRICULAR RHYTHM AT 60 BPM SLOWING TO AN IDIOVENTRICULAR RHYTHM AT 40 BPM DEGRADING TO ASYSTOLE WITH CPR AND MOTION ARTIFACT UNTIL THE ELECTRODE BELT WAS DISCONNECTED AT 07:06:52. THERE IS NO INDICATION OF ANY DEVICE MALFUNCTION THAT CAUSED OR CONTRIBUTED TO THE PATIENT'S PASSING, THE PATIENT'S EQUIPMENT WAS RETURNED AND WAS FOUND TO BE FULLY FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736207 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death| H| O