BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 10758103 · Received October 29, 2020

    Report

    Report Number
    3008642652-2020-09506
    Event Type
    Death
    Date Received
    October 29, 2020
    Date of Event
    September 20, 2020
    Report Date
    October 28, 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

    MONITOR MANUFACTURE DATE: 04/19/2019. BELT MANUFACTURE DATE: 10/25/2012. DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (PATIENT DEATH) WAS CONFIRMED. THE EVALUATION INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAY OF THE EVENT AND INCOMING FUNCTIONAL TESTING. 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 TO REPORT THAT A PATIENT HAD PASSED AWAY ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT WAS WEARING THE LIFEVEST AND IN THE HOSPITAL AT THE TIME OF PASSING. THE DEVICE WAS STARTED UP AT 13:18:28 ON (B)(6) 2020. BRADYCARDIA WAS DETECTED AT 11:42:53 ON (B)(6) 2020. ASYSTOLE WAS DETECTED AT 11:48:56. THE ECG SHOWS IDIOVENTRICULAR RHYTHM AT 70 BPM DEGRADING TO VF WITH MOTION ARTIFACT, VARYING HEART RATE, AND VARYING AMPLITUDES. AN ARRHYTHMIA WAS DETECTED AT 11:49:08 WITH RESPONSE BUTTON USE. THE ECG SHOWS VF WITH VARYING HEART RATE, AND VARYING AMPLITUDES. DETECTION STOPPED AT 11:49:12. THE DEVICE WAS SHUTDOWN AT 11:49:20 ON (B)(6) 2020. THE PATIENT WAS IN A IDIOVENTRICULAR RHYTHM AT 70 BPM DEGRADING TO VF WITH MOTION ARTIFACT, VARYING HEART RATE, VARYING AMPLITUDES, AND RESPONSE BUTTON USE FROM APPROXIMATELY 11:47:35 UNTIL THE DEVICE SHUTDOWN AT 11:49:20 ON (B)(6) 2020. THE VARYING HEART RATE, AMPLITUDE, AND INTERMITTENT RESPONSE BUTTON USE PREVENTED THE LIFEVEST FROM DELIVERING A TREATMENT WHILE THE PATIENT WAS IN VF. IT WAS NOT REPORTED WHO PRESSED THE RESPONSE BUTTONS. THERE WERE NO DEFICIENCIES ALLEGED. THE DEVICE WAS FULLY FUNCTIONAL UPON RECEIPT. THERE IS NO INDICATION THAT THE LIFEVEST CAUSED OR CONTRIBUTED TO THE PATIENT DEATH. REPORTING THE EVENT OUT OF AN ABUNDANCE OF CAUTION DUE TO POTENTIAL BYSTANDER INTERFERENCE PREVENTING THE LIFEVEST FROM DELIVERING A TREATMENT DURING VF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219270 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| H| O