BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 12057760 · Received June 24, 2021

    Report

    Report Number
    3008642652-2021-05300
    Event Type
    Death
    Date Received
    June 24, 2021
    Date of Event
    May 14, 2021
    Report Date
    June 22, 2021
    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) HAS BEEN COMPLETED. DURING THE INCOMING FUNCTIONAL TESTING, A 1 HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE ECG ELECTRODES, FOLLOWED BY A 5 HZ SIMULATED TREATABLE ARRHYTHMIA SIGNAL WHICH VERIFIED PROPER PERFORMANCE OF THE DETECTION ALGORITHM. DURING THE TRANSITION TO THE 5 HZ 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 EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON INVESTIGATION THE ELECTRODE BELT WAS UNABLE TO UNDERGO INCOMING FUNCTIONAL TESTING. THE CAUSE FOR THE FAILURE WAS ISOLATED TO SHORT BETWEEN THE GEL FIRE AND PULSE DELIVERY CIRCUITRY OF THE REAR THERAPY ELECTRODES. A ROOT CAUSE INVESTIGATION DETERMINED THAT CONDUCTIVE GEL FROM THE THERAPY ELECTRODES INGRESSED INTO THE THERAPY ELECTRODE ENCLOSURE, CAUSING A SHORT BETWEEN THE GEL FIRE AND PULSE DELIVERY CIRCUITRY. THERE IS NO INDICATION THAT THE DAMAGED BELT CAUSED OR CONTRIBUTED TO THE PATIENT'S PASSING. DEVICE MANUFACTURE DATE: MONITOR 10/23/2019, BELT 05/06/2015.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY IN A REHAB FACILITY WHILE WEARING THE LIFEVEST ON (B)(6) 2021. REVIEW OF THE DOWNLOAD DATA INDICATES THE PATIENT RECEIVED FOUR INAPPROPRIATE TREATMENTS IN RESPONSE TO DOUBLE COUNTING AND MOTION ARTIFACT ON THE DAY PRIOR TO PASSING, (B)(6) 2021. THE PATIENT WAS IN A PACED RHYTHM AT 70 BPM WITH TALL T WAVES AT 17:55:32 ON (B)(6) 2021. THE PATIENT RECEIVED THE FIRST INAPPROPRIATE TREATMENT AT 17:56:11. THE PATIENT'S RHYTHM AT THE TIME OF TREATMENT WAS A PACED RHYTHM AT 70 BPM WITH TALL T WAVES. THE PATIENT'S POST-SHOCK RHYTHM WAS A PACED RHYTHM AT 50 BPM WITH TALL T WAVES. THE PATIENT RECEIVED THE SECOND INAPPROPRIATE TREATMENT AT 20:23:46. THE PATIENT'S RHYTHM AT THE TIME OF TREATMENT WAS A PACED RHYTHM AT 70 BPM WITH TALL T WAVES AND MOTION ARTIFACT. THE PATIENT'S POST-SHOCK RHYTHM WAS SINUS RHYTHM AT 70 BPM WITH MOTION ARTIFACT. THE PATIENT RECEIVED THE THIRD INAPPROPRIATE TREATMENT AT 20:50:37. THE PATIENT'S RHYTHM AT THE TIME OF TREATMENT WAS A PACED RHYTHM AT 70 BPM WITH TALL T WAVES AND TACTILE ARTIFACT. THE PATIENT'S POST-SHOCK RHYTHM WAS SINUS RHYTHM AT 70 BPM WITH MOTION ARTIFACT. THE PATIENT RECEIVED THE FOURTH INAPPROPRIATE TREATMENT AT 21:17:37. THE PATIENT'S RHYTHM AT THE TIME OF TREATMENT WAS A PACED RHYTHM AT 70 BPM WITH TALL T WAVES. THE PATIENT'S POST-SHOCK RHYTHM WAS A PACED RHYTHM AT 65 BPM. THE PATIENT'S RHYTHM DEGRADED TO ASYSTOLE WITH PACEMAKER SPIKES AND CPR/MOTION ARTIFACT AT 08:50:51 ON (B)(6) 2021. THE PATIENT WAS IN ASYSTOLE WITH PACEMAKER SPIKES AT THE TIME OF THE DEVICE SHUTDOWN AT 09:57:49 ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956721 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 Death