BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 10854119 · Received November 17, 2020

    Report

    Report Number
    3008642652-2020-10220
    Event Type
    Death
    Date Received
    November 17, 2020
    Date of Event
    October 13, 2020
    Report Date
    November 17, 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. 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. DEVICE MANUFACTURER DATE: MONITOR: 05/23/2013, ELECTRODE BELT: 03/30/2018.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY. IT WAS REPORTED THAT THE PATIENT PASSED AWAY AT THE HOSPITAL, WHILE WEARING THE LIFEVEST.   REVIEW OF THE DOWNLOAD DATA INDICATES THAT THE PATIENT ENTERED VENTRICULAR FIBRILLATION (VF) AT 05:33:50 ON (B)(6) 2020. THE PATIENT EXPERIENCED A TREATMENT EVENT CONSISTING OF FIVE SHOCKS. THE LIFEVEST TREATED THE PATIENT APPROPRIATELY AT 05:34:31 WHILE THE PATIENT WAS IN VENTRICULAR TACHYCARDIA (VT) AT 260 BPM. THE POST-SHOCK RHYTHM WAS BRADYCARDIA AT 30 BPM WITH PVCS. THE PATIENT EXPERIENCED A SECOND APPROPRIATE TREATMENT WHILE THE PATIENT'S RHYTHM WAS VT AT 230 BPM, AND THE POST-SHOCK RHYTHM WAS ASYSTOLE WITH CARDIAC ACTIVITY AND MOTION ACTIVITY. POST-SHOCK ASYSTOLE IS A KNOWN AND POTENTIALLY ADVERSE OUTCOME OF DEFIBRILLATION THERAPY. AT 05:47:13 THE PATIENT EXPERIENCED A THIRD APPROPRIATE TREATMENT WHILE THE PATIENT'S RHYTHM WAS VT AT 220 BPM, BUT THE RHYTHM WAS UNABLE TO CONVERT AND THE POST-SHOCK RHYTHM WAS VT AT 210 BPM WITH MOTION/TACTILE ARTIFACT. AT 05:47:13, THE PATIENT EXPERIENCED A FOURTH APPROPRIATE TREATMENT WHILE THE PATIENT'S RHYTHM WAS VT AT 200 BPM, AND THE POST-SHOCK RHYTHM WAS SINUS TACHYCARDIA AT 115 BPM THAT TRANSITIONS TO SINUS BRADYCARDIA AT 50 BPM WHICH FURTHER DEGRADES TO VT. THE PATIENT EXPERIENCED A FIFTH APPROPRIATE TREATMENT AT 05:48:09 WHILE THE PATIENT'S RHYTHM WAS VT AT 215 BPM, AND THE POST-SHOCK RHYTHM WAS SINUS TACHYCARDIA AT 125 BPM WITH MOTION ARTIFACT WHICH DEGRADED TO VT AT 240 BPM WITH MOTION ARTIFACT AND ECG INTERFERENCE/DISCONNECTION. THE RESPONSE BUTTONS WERE PRESSED AFTER THE EVENTS. IT IS UNSURE WHO WAS PRESSING THE RESPONSE BUTTONS. THE ELECTRODE BELT WAS DISCONNECTED AT 05:48:24. THE PATIENT PASSED AWAY ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320986 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H