BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 8646905 · Received May 28, 2019

    Report

    Report Number
    3008642652-2019-03962
    Event Type
    Death
    Date Received
    May 28, 2019
    Date of Event
    April 27, 2019
    Report Date
    May 22, 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 SUMMARY: MONITOR SN (B)(4) AND BELT SN (B)(4) WERE RETURNED AND EVALUATED AT ZOLL MANUFACTURING CORPORATION. THE EVALUATION INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAY OF THE EVENT AND INCOMING FUNCTIONAL TESTING. THE REVIEW OF THE SOFTWARE FLAGS CONSISTED OF AN ANALYSIS OF THE DOWNLOADED DATA TO IDENTIFY ANY FAULT FLAGS OR UNUSUAL PATTERNS OF SOFTWARE FLAGS. THE SOFTWARE FLAG FILES DID NOT SUGGEST A DEVICE MALFUNCTION THAT WOULD CONTRIBUTE TO THE INAPPROPRIATE TREATMENT EVENT. 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 CONTRIBUTING TO THE DEFIBRILLATION EVENT. MANUFACTURE DATE: ELECTRODE BELT: 11/01/2012; MONITOR: 10/06/2015.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT WAS TREATED PRIOR TO PASSING AWAY ON THE MORNING OF (B)(6) 2019 WHILE WEARING THE LIFEVEST. THE PATIENT WAS UNCONSCIOUS AND WITH HIS GIRLFRIEND AT THE TIME OF PASSING. PER REVIEW OF THE DOWNLOAD DATA, THE PATIENT'S RHYTHM TRANSITIONED TO SINUS BRADYCARDIA AT 20 BPM, DEGRADING TO ASYSTOLE AT 03:52:15. THE LIFEVEST DELIVERED FOUR INAPPROPRIATE TREATMENT SHOCKS BETWEEN 03:52:51 AND 03:58:59 AM WHILE THE PATIENT WAS IN ASYSTOLE. THE POST SHOCK RHYTHM AFTER THE FOURTH TREATMENT SHOCK WAS AN IDIOVENTRICULAR RHYTHM AT 35 BPM DEGRADING TO ASYSTOLE WITH TACTILE/MOTION ARTIFACT. OVERSENSING OF THE LOW-AMPLITUDE CARDIAC SIGNAL AND THE INTERMITTENT CARDIAC ACTIVITY CONTRIBUTED TO THE FALSE DETECTIONS. THERE IS NO EVIDENCE THAT THE TREATMENT CAUSED OR CONTRIBUTED TO THE DEATH AS THE PATIENT WAS ALREADY IN A NON-LIFE SUSTAINING RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441354 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| O