BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 10125371 · Received June 5, 2020

    Report

    Report Number
    3008642652-2020-05043
    Event Type
    Death
    Date Received
    June 5, 2020
    Date of Event
    April 17, 2020
    Report Date
    June 5, 2020
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MONITOR SN (B)(4) WAS RETURNED AND EVALUATED AT THE DISTRIBUTOR. 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. DURING THE INCOMING FUNCTIONAL TESTING, A 1HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE MONITOR, 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 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. ELECTRODE BELT SN (B)(4) WAS REPORTEDLY THROWN OUT BY THE BY THE FUNERAL HOME AND THERE IS NO INDICATION THAT IT WILL BE RETURNED FOR EVALUATION. DEVICE EVALUATION INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAY OF THE EVENT. 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 PATIENT'S PASSING. MANUFACTURE DATES: MONITOR: 2/25/2020, ELECTRODE BELT: 7/9/2019.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL AND REPORTED THAT A PATIENT PASSED AWAY ON (B)(6) 2020 WHILE WEARING THE LIFEVEST. IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL AT THE TIME OF PASSING. REVIEW OF THE PATIENT'S DOWNLOAD DATA REVEALED THAT THE PATIENT RECEIVED A TREATMENT EVENT CONSISTING OF 15 SHOCKS. BETWEEN 2:35:41 AM AND 7:00:53 AM, THE PATIENT RECEIVED 14 APPROPRIATE TREATMENTS AND 1 INAPPROPRIATE TREATMENT. TREATMENTS 1 THROUGH 5 WERE APPROPRIATELY DELIVERED DURING VENTRICULAR TACHYCARDIA (VT) OR VENTRICULAR FIBRILLATION (VF). ALL FIVE OF THE TREATMENTS CONVERTED THE ARRHYTHMIAS TO SLOWER RHYTHMS. AT 6:15:02 AM THE PATIENT RECEIVED AN INAPPROPRIATE TREATMENT WHILE THE PATIENT WAS IN SINUS BRADYCARDIA AT 40 BPM WITH MOTION ARTIFACT AND AMPLITUDE OVERSENSING. THE POST-SHOCK RHYTHM WAS SINUS TACHYCARDIA AT 100 BPM WITH PVCS, INTERMITTENT NSVT, AND MOTION ARTIFACT. MOTION ARTIFACT AND AMPLITUDE OVERSENSING CONTRIBUTED TO THE FALSE DETECTION. AT 6:21:20, THE SEVENTH TREATMENT WAS DELIVERED WHILE THE PATIENT'S RHYTHM WAS VF AT THE TIME OF THE TREATMENT, AND THE POST-SHOCK RHYTHM WAS VT AT 220 BPM. AT 6:21:54 AM, THE EIGHTH TREATMENT WAS DELIVERED BY THE LIFEVEST WHILE THE PATIENT WAS IN VT AT 210 BPM, AND THE POST-SHOCK RHYTHM WAS 210 BPM. AT 6:23:16 AM, THE PATIENT RECEIVED THE NINTH TREATMENT FROM THE LIFEVEST WHILE THE PATIENT'S RHYTHM WAS VT AT 210 BPM, AND THE POST-SHOCK RHYTHM WAS SINUS BRADYCARDIA AT 45 BPM TRANSITIONING TO SINUS TACHYCARDIA AT 105 BPM WITH PVCS. AT 6:24:53 AM AND 6:25:58 AM, THE PATIENT RECEIVED THE TENTH AND ELEVENTH TREATMENTS FROM THE LIFEVEST WHILE THE PATIENT WAS IN VF. THE POST-SHOCK RHYTHM FOR BOTH TREATMENTS WAS VT AT 200 AND 210 BPM. AT 6:26:29 AM THE PATIENT RECEIVED THE TWELFTH TREATMENT FROM THE LIFEVEST. THE PATIENT'S RHYTHM WAS VT AT 200 BPM, AND THE POST-SHOCK RHYTHM WAS INDUCED VF. AT 6:27:01 AM, 6:46:02 AM, AND 7:00:53 AM, THE PATIENT RECEIVED TREATMENTS 13, 14, AND 15 FROM THE LIFEVEST. THE PATIENT'S RHYTHM AT THE TIME OF ALL THREE TREATMENTS WAS VF, AND THE POST-SHOCK RHYTHM WAS ASYSTOLE. POST-SHOCK ASYSTOLE IS A KNOWN POTENTIALLY ADVERSE OUTCOME OF DEFIBRILLATION THERAPY. THE RESPONSE BUTTONS WERE PRESSED THROUGHOUT THE EVENT, HOWEVER IT IS NOT KNOWN WHO WAS PRESSING THE RESPONSE BUTTONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588505 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death| H| O