BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6838915 · Received September 1, 2017

    Report

    Report Number
    3008642652-2017-07328
    Event Type
    Death
    Date Received
    September 1, 2017
    Date of Event
    July 16, 2017
    Report Date
    September 1, 2017
    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 DEVICE MALFUNCTION. BOTH THE MONITOR AND ELECTRODE BELT WERE FUNCTIONALLY TESTED AND MET SPECIFICATIONS. THERE WAS NO DEVICE MALFUNCTION ASSOCIATED WITH THIS EVENT. THE DEVICE DID NOT TREAT THE PATIENT'S VENTRICULAR TACHYCARDIA BECAUSE THE PATIENT'S RATE DROPPED BELOW THE PRESCRIBED THRESHOLD OF 180 BPM BEFORE A TREATMENT SHOCK COULD BE DELIVERED. SIGNIFICANT MOTION ARTIFACT PREVENTED THE DEVICE FROM DETECTING THE SUBSEQUENT PATIENT'S VENTRICULAR FIBRILLATION. THE CAUSE OF THE MOTION ARTIFACT COULD NOT BE POSITIVELY DETERMINED. DEVICE MANUFACTURE DATE: MONITOR SN (B)(4): 06/11/2015, ELECTRODE BELT SN (B)(4): 02/03/2012.

    Description of Event or Problem · 1

    ON (B)(6) 2017, ZOLL RECEIVED INFORMATION FROM A CLINICAL ANALYSIS OF A (B)(6) PATIENT'S DEATH THAT CONCLUDED THAT THE PATIENT WAS IN A TREATABLE ARRHYTHMIA PRIOR TO PASSING. THE ANALYSIS DETERMINED THAT THE PATIENT EXPERIENCED VENTRICULAR TACHYCARDIA WHICH THE LIFEVEST DID DETECT. THE ARRHYTHMIA DETECTION SEQUENCE ENDED WHEN THE PATIENT'S RHYTHM TRANSITIONED TO VENTRICULAR TACHYCARDIA AT 170 BPM, WHICH WAS BELOW THE PROGRAMMED TREATMENT THRESHOLD PARAMETER (180 BPM) FOR VENTRICULAR TACHYCARDIA. THE PATIENT WAS NOT TREATED BY THE DEVICE. ZOLL'S INVESTIGATION FOUND THAT THE PATIENT HAD PASSED AWAY AT HOME ON (B)(6) 2017 WHILE WEARING THE LIFEVEST. THE CAUSE OF DEATH WAS REPORTED TO BE A HEART ATTACK BY AN EMERGENCY DOCTOR. THE PATIENT'S HUSBAND WITNESSED THE EVENT. THE PATIENT'S HUSBAND REPORTED THAT A SIREN ALERT SOUNDED AND WAS FOLLOWED BY A VOICE PROMPT TO START CPR. THIS IS THE STANDARD OPERATION OF THE LIFEVEST WHEN ASYSTOLE IS DETECTED. THE PATIENT'S HUSBAND REPORTED THAT THE PATIENT HAD BEEN ASLEEP, WOKEN UP, AND WAS GOING TO THE TOILET. THE PATIENT THEN COLLAPSED AND WENT UNCONSCIOUS. EVALUATION OF THE EVENT WAS ACCOMPLISHED THROUGH A CLINICAL ANALYSIS OF THE CONTINUOUS ECG DATA STORED ON THE PATIENT'S MONITOR. ACCORDING TO THE PATIENT FLAG FILES AND CONTINUOUS ECG RECORDINGS, AN ARRHYTHMIA WAS DETECTED BY THE LIFEVEST AT 21:47:27 ON (B)(6) 2017. THE ECG RECORDINGS SHOW THE PATIENT WAS IN A SINUS RHYTHM AT 85 BEATS PER MINUTE (BPM) TRANSITIONING TO VENTRICULAR TACHYCARDIA AT 200 BPM WITH VARYING AMPLITUDE FOR 27 SECONDS. THE PATIENT'S VENTRICULAR TACHYCARDIA THEN SLOWED TO 170 BPM. THE LIFEVEST ARRHYTHMIA DETECTION STOPPED AT 21:47:54 ON (B)(6) 2017 AS THE PATIENT'S RATE HAD DROPPED BELOW THE PRESCRIBED THRESHOLD OF 180 BPM. THE LIFEVEST REQUIRES APPROXIMATELY 60 SECONDS OF SUSTAINED VENTRICULAR TACHYCARDIA ABOVE THE PROGRAMMED THRESHOLD IN ORDER TO DELIVER A TREATMENT SHOCK. FROM 21:47:54 TO 21:48:54 ON (B)(6) 2017 THE PATIENT WAS IN VENTRICULAR TACHYCARDIA FROM 170 BPM TO 240 BPM WITH MOTION ARTIFACT EVIDENT IN THE RECORDING. THE VENTRICULAR TACHYCARDIA WAS NOT SUSTAINED ABOVE 180 BPM LONG ENOUGH FOR THE LIFEVEST TO INITIATE A TREATMENT SEQUENCE. THE PATIENT'S RHYTHM THEN TRANSITIONED TO VENTRICULAR FIBRILLATION WITH MOTION ARTIFACT EVIDENT IN THE ECG RECORDING. THE VENTRICULAR FIBRILLATION WAS PRESENT FROM 21:48:57 UNTIL 21:51:06 ON (B)(6) 2017. THE LIFEVEST DID NOT DETECT THE PATIENT'S UNDERLYING VENTRICULAR FIBRILLATION BECAUSE OF THE SIGNIFICANT MOTION ARTIFACT ON ONE DETECTION CHANNEL. FOR 18 SECONDS, THE PATIENT'S RHYTHM TRANSITIONED TO VENTRICULAR TACHYCARDIA AT 180 BPM. THE PATIENT THEN TRANSITIONED BACK TO VENTRICULAR FIBRILLATION WITH MOTION ARTIFACT FROM 21:51:24 TO 21:52:42. ASYSTOLE WAS THEN DETECTED BY THE LIFEVEST TWICE ON (B)(6) 2017, AT 21:52:43 AND 21:55:50. THE ECG RECORDINGS SHOW THE PATIENT IN AN IDIOVENTRICULAR RHYTHM FROM 60 TO 95 BPM DEGRADING TO ASYSTOLE. THE PATIENT REMAINED IN ASYSTOLE WITH INTERMITTENT CARDIAC ACTIVITY UNTIL THE TIME OF THE ELECTRODE BELT DISCONNECTION AT 22:02:31 ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617882 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death