BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 13732023 · Received March 11, 2022

    Report

    Report Number
    3008642652-2022-02256
    Event Type
    Death
    Date Received
    March 11, 2022
    Date of Event
    February 20, 2022
    Report Date
    March 7, 2022
    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 · 0

    THE ELECTRODE BELT AND MONITOR HAVE NOT BEEN RECOVERED. THE DEVICE FLAG DATA FROM THE LAST DOWNLOAD DOES NOT INDICATE ANY DEVICE MALFUNCTION.

    Description of Event or Problem · 0

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY WHILE WEARING THE LIFEVEST ON (B)(6) 2022. REVIEW OF THE DOWNLOAD DATA, INDICATES THE PATIENT RECEIVED FIVE APPROPRIATE TREATMENTS DURING VF AND TWO INAPPROPRIATE TREATMENTS IN RESPONSE TO OVERSENSING CARDIAC ACTIVITY AND MOTION ARTIFACT. AT 06:48:27, THE PATIENT RECEIVED THE FIRST APPROPRIATE TREATMENT. THE PATIENT'S RHYTHM AT THE TIME OF THE TREATMENT EVENT WAS VF WITH MOTION ARTIFACT. THE PATIENT'S POST-SHOCK RHYTHM WAS SINUS BRADYCARDIA AT 30 BPM WITH MOTION ARTIFACT AND HB. AT 06:48:59, THE PATIENT RECEIVED THE FIRST INAPPROPRIATE TREATMENT. THE PATIENT'S RHYTHM AT THE TIME OF THE TREATMENT EVENT WAS SINUS BRADYCARDIA AT 30 BPM WITH MOTION ARTIFACT AND HB. THE PATIENT'S POST-SHOCK RHYTHM WAS SINUS BRADYCARDIA AT 30 BPM WITH MOTION ARTIFACT AND HB. FROM 06:54:32 TO 06:57:57, THE PATIENT'S RHYTHM WAS SINUS TACHYCARDIA AT 120 BPM SLOWING TO SINUS BRADYCARDIA AT 10 BPM. THE RHYTHM THE TRANSITIONS TO VT FROM 140-110 BPM WITH VARYING RATES DEGRADING TO ASYSTOLE WITH UNCONDUCTED P WAVES AND INTERMITTENT CARDIAC ACTIVITY/NSVT. THE RATE OF THE VT ARRHYTHMIA WAS LESS THAN THE PHYSICIAN-PRESCRIBED RATE THRESHOLD OF 150 BPM. THE LIFEVEST TYPICALLY REQUIRES 60 SECONDS OF SUSTAINED VT ABOVE THE RATE THRESHOLD TO DELIVER A TREATMENT SHOCK. AT 07:01:01, THE PATIENT RECEIVED THE SECOND APPROPRIATE TREATMENT. THE PATIENT'S RHYTHM AT THE TIME OF THE TREATMENT EVENT WAS VF WITH MOTION ARTIFACT. THE PATIENT'S POST-SHOCK RHYTHM WAS ASYSTOLE. AT 07:02:18, THE PATIENT RECEIVED THE THIRD APPROPRIATE TREATMENT. THE PATIENT'S RHYTHM AT THE TIME OF THE TREATMENT EVENT WAS VF WITH MOTION ARTIFACT. THE PATIENT'S POST-SHOCK RHYTHM WAS ASYSTOLE WITH INTERMITTENT CARDIAC ACTIVITY. AT 07:06:34, THE PATIENT RECEIVED THE FOURTH APPROPRIATE TREATMENT. THE PATIENT'S RHYTHM AT THE TIME OF THE TREATMENT EVENT WAS VF WITH MOTION ARTIFACT. THE PATIENT'S POST-SHOCK RHYTHM WAS ASYSTOLE WITH INTERMITTENT CARDIAC ACTIVITY. AT 07:09:29, THE PATIENT RECEIVED THE FIFTH APPROPRIATE TREATMENT. THE PATIENT'S RHYTHM AT THE TIME OF THE TREATMENT EVENT WAS VF WITH MOTION ARTIFACT. THE PATIENT'S POST-SHOCK RHYTHM WAS ASYSTOLE WITH INTERMITTENT CARDIAC ACTIVITY. AT 07:12:29, THE PATIENT RECEIVED THE SECOND INAPPROPRIATE TREATMENT. THE PATIENT'S RHYTHM AT THE TIME OF THE TREATMENT EVENT WAS ASYSTOLE WITH INTERMITTENT CARDIAC ACTIVITY. THE PATIENT'S POST-SHOCK RHYTHM WAS ASYSTOLE WITH INTERMITTENT CARDIAC ACTIVITY. FROM 07:12:59 TO 07:21:53, THE PATIENT'S RHYTHM WAS INTERMITTENTLY ASYSTOLE WITH INTERMITTENT CARDIAC ACTIVITY. POST-SHOCK ASYSTOLE IS A KNOWN AND POTENTIALLY ADVERSE OUTCOME OF DEFIBRILLATION THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1525956 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death