BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 10669578 · Received October 13, 2020

    Report

    Report Number
    3008642652-2020-08695
    Event Type
    Death
    Date Received
    October 13, 2020
    Date of Event
    August 24, 2020
    Report Date
    October 6, 2020
    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. 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 - (B)(4) - 05/21/2013. ELECTRODE BELT - (B)(4) - 10/23/2013.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY ON (B)(6) 2020 WHILE REPORTEDLY WEARING THE LIFEVEST. THE PATIENT REPORTEDLY COLLAPSED AND THE PATIENT'S WIFE WAS NOT PRESENT. ASYSTOLE WAS DETECTED TWICE BY THE LIFEVEST FROM 10:20:10 TO 10:28:36 WHEN THE PATIENT'S ECG RECORDINGS SHOW ASYSTOLE WITH CPR/MOTION ARTIFACT. PER CLINICAL REVIEW OF THE PATIENT'S CONTINUOUS ECG RECORDINGS, THE PATIENT WAS IN ASYSTOLE WITH CPR/MOTION ARTIFACT, THEN THEIR RHYTHM TRANSITIONED TO AN IDIOVENTRICULAR RHYTHM AT 90 BPM THAT THEN DEGRADED BACK TO ASYSTOLE WITH CPR/MOTION ARTIFACT. THE PATIENT'S RHYTHM THEN CHANGED TO VENTRICULAR FIBRILLATION (VF) WITH CPR/MOTION ARTIFACT FROM APPROXIMATELY 10:29:06 TO 10:37:51. THE CPR/MOTION ARTIFACT PREVENTED THE LIFEVEST FROM DELIVERING A TREATMENT DURING THIS TIME. THE PATIENT RECEIVED A NON-LIFEVEST DEFIBRILLATION. THE PATIENT'S RHYTHM AT THE TIME OF THE NON-LIFEVEST TREATMENT AS VF WITH CPR/MOTION ARTIFACT, AND THE PATIENT'S POST-SHOCK RHYTHM WAS ASYSTOLE WITH CPR/MOTION ARTIFACT. THE PATIENT REMAINED IN ASYSTOLE WITH CPR/MOTION ARTIFACT FROM 10:38:03 UNTIL THE ELECTRODE BELT WAS DISCONNECTED AT 10:48:14. THE PATIENT SUBSEQUENTLY PASSED AWAY. 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
    1137747 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death