BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 15824692 · Received November 18, 2022

    Report

    Report Number
    3008642652-2022-25676
    Event Type
    Death
    Date Received
    November 18, 2022
    Date of Event
    October 7, 2022
    Report Date
    November 17, 2022
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    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 ON (B)(6) 2022 WHILE REPORTEDLY WEARING THE LIFEVEST. THE PATIENT RECEIVED TWELVE APPROPRIATE TREATMENTS, SIX OF WHICH CONVERTED THE ARRHYTHMIAS TO A SLOWER RHYTHM AND SIX WHICH DID NOT CONVERT THE ARRHYTHMIAS. THE PATIENT ALSO RECEIVED AN INAPPROPRIATE TREATMENT. THE DEVICE WAS STARTED UP AT 19:39:07 ON (B)(6) 2022. AT 08:10:13 ON (B)(6) 2022, AN ARRHYTHMIA WAS DETECTED. ECG SHOWS VT @ 280 BPM. AT 08:10:49, THE PATIENT RECEIVED THE FIRST APPROPRIATE TREATMENT. THE RHYTHM AT THE TIME OF TREATMENT WAS VT @ 260 BPM WITH MOTION ARTIFACT. THE POST SHOCK RHYTHM WAS VT @ 240 BPM WITH MOTION ARTIFACT. AT 08:11:20, THE PATIENT RECEIVED THE SECOND APPROPRIATE TREATMENT. THE RHYTHM AT THE TIME OF TREATMENT WAS VT @ 240 BPM. THE POST SHOCK RHYTHM WAS VT @ 230 BPM. AT 08:11:54, THE PATIENT RECEIVED THE THIRD APPROPRIATE TREATMENT. THE RHYTHM AT THE TIME OF TREATMENT WAS VT @ 250 BPM. THE POST SHOCK RHYTHM WAS SINUS BRADYCARDIA/SINUS RHYTHM FROM 30-60 BPM WITH PVC¿S. AT 08:13:02, AN ARRHYTHMIA WAS DETECTED. ECG SHOWS SVT @ 180 BPM WITH NSVT. AT 08:14:43, THE PATIENT RECEIVED THE FOURTH APPROPRIATE TREATMENT. THE RHYTHM AT THE TIME OF TREATMENT WAS VT @ 260 BPM. THE POST SHOCK RHYTHM WAS SINUS BRADYCARDIA @ 50 BPM WITH PVC¿S. THE RHYTHM THEN TRANSITIONS TO SVT FROM 190-170 BPM WITH NSVT. AT 08:21:19, THE PATIENT RECEIVED THE FIFTH APPROPRIATE TREATMENT. THE RHYTHM AT THE TIME OF TREATMENT WAS VF. THE POST SHOCK RHYTHM WAS SINUS RHYTHM/SVT FROM 60-190 BPM WITH NSVT. AT 08:23:09, AN ARRHYTHMIA WAS DETECTED. ECG SHOWS VT @ 290 BPM. AT 08:24:01, THE PATIENT RECEIVED THE SIXTH APPROPRIATE TREATMENT. THE RHYTHM AT THE TIME OF TREATMENT WAS VT @ 290 BPM. THE POST SHOCK RHYTHM WAS VT FROM 150-190 BPM WITH MOTION ARTIFACT. AT 08:24:28, THE PATIENT RECEIVED THE SEVENTH APPROPRIATE TREATMENT. THE RHYTHM AT THE TIME OF TREATMENT WAS VT @ 200 BPM. THE POST SHOCK RHYTHM WAS SINUS BRADYCARDIA @ 50 BPM WITH MOTION ARTIFACT AND PVC¿S. AT 08:26:59, AN ARRHYTHMIA WAS DETECTED. ECG SHOWS SVT @ 180 BPM DEGRADING TO VT @ 180 BPM. AT 08:28:08, THE PATIENT RECEIVED THE EIGHTH APPROPRIATE TREATMENT. THE RHYTHM AT THE TIME OF TREATMENT WAS VT @ 180 BPM. THE POST SHOCK RHYTHM WAS SVT @ 150 BPM WITH NSVT. AT 08:28:30, THE PATIENT RECEIVED THE NINTH APPROPRIATE TREATMENT. THE RHYTHM AT THE TIME OF TREATMENT WAS VT @ 260 BPM. THE POST SHOCK RHYTHM WAS SVT @ 180 BPM WITH NSVT. AT 08:32:38, THE PATIENT RECEIVED THE TENTH APPROPRIATE TREATMENT. THE RHYTHM AT THE TIME OF TREATMENT WAS VT @ 270 BPM. THE POST SHOCK RHYTHM WAS SINUS RHYTHM @ 80 BPM. AT 08:33:55, AN ARRHYTHMIA WAS DETECTED. ECG SHOWS VT @ 190 BPM. AT 08:34:27, THE PATIENT RECEIVED THE ELEVENTH APPROPRIATE TREATMENT. THE RHYTHM AT THE TIME OF TREATMENT WAS VT @ 200 BPM. THE POST SHOCK RHYTHM WAS VT @ 290 BPM. AT 08:34:48, THE PATIENT RECEIVED THE TWELFTH APPROPRIATE TREATMENT. THE RHYTHM AT THE TIME OF TREATMENT WAS VT @ 270 BPM. THE POST SHOCK RHYTHM WAS SINUS RHYTHM @ 90 BPM WITH PVC¿S. AT 08:36:36, AN ARRHYTHMIA WAS DETECTED. ECG SHOWS SVT @ 160 BPM WITH NSVT. AT 08:37:08, THE PATIENT RECEIVED THE INAPPROPRIATE TREATMENT. NSVT CONTRIBUTED TO THE FALSE DETECTION. THE RHYTHM AT THE TIME OF TREATMENT WAS NSVT. THE POST SHOCK RHYTHM WAS VT @ 220 BPM. THE ELECTRODE BELT WAS DISCONNECTED AT 10:49:34 ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229960 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death