BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 7707221 · Received July 20, 2018

    Report

    Report Number
    3008642652-2018-06384
    Event Type
    Death
    Date Received
    July 20, 2018
    Date of Event
    June 22, 2018
    Report Date
    July 19, 2018
    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 (B)(4) AND ELECTRODE BELT (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.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL AND REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2018 WHILE AT HOME. AT APPROXIMATELY 20:23:58 THE PATIENT DEGRADED FROM AN IDIOVENTRICULAR RHYTHM (90 BPM) TO VT (140 - 200 BPM). THE PATIENT WAS IN VT FOR APPROXIMATELY FOUR MINUTES. THE VT ARRHYTHMIA WAS DETECTED BY THE LIFEVEST, BUT THE LIFEVEST FELL OUT OF DETECTION AND DID NOT TREAT THE ARRHYTHMIA BECAUSE OF MOTION ARTIFACT AND THE VARYING RATE OF THE ARRHYTHMIA. THE PATIENT DEGRADED TO ASYSTOLE AT 20:47:04 AND REMAINED IN ASYSTOLE UNTIL THE ELECTRODE BELT WAS DISCONNECTED AT 00:08:46 ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549058 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death