BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 19911415 · Received August 5, 2024

    Report

    Report Number
    3008642652-2024-07982
    Event Type
    Death
    Date Received
    August 5, 2024
    Date of Event
    July 2, 2024
    Report Date
    August 5, 2024
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MONITOR HAS BEEN RETURNED AND THE EVALUATION IS UNDERWAY. THE DEVICE FLAG DATA FROM THE LAST DOWNLOAD DOES NOT INDICATE ANY DEVICE MALFUNCTION. THE ELECTRODE BELT HAS 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) 2024 WHILE REPORTEDLY WEARING THE LIFEVEST. THE PATIENT RECEIVED THREE APPROPRIATE TREATMENTS AND TWO INAPPROPRIATE TREATMENTS. THE DEVICE WAS STARTED UP AT 15:41:51 ON (B)(6) 2024. AT 16:40:02, AN ARRHYTHMIA WAS DETECTED. ECG SHOWS AN SINUS BRADYCARDIA @ 30 BPM WITH CPR/MOTION ARTIFACT. THE RHYTHM THEN DEGRADES TO VT @ 270 BPM. AT 16:40:37, THE PATIENT RECEIVED THE FIRST APPROPRIATE TREATMENT. RHYTHM AT THE TIME OF TREATMENT WAS VT @ 270 BPM. POST SHOCK RHYTHM WAS SINUS BRADYCARDIA @ 50 BPM WITH PAC¿S. AT 16:46:26, AN ARRHYTHMIA WAS DETECTED. ECG SHOWS VT @ 270 BPM. AT 16:46:57, THE PATIENT RECEIVED THE SECOND APPROPRIATE TREATMENT. RHYTHM AT THE TIME OF TREATMENT WAS VT @ 260 BPM. POST SHOCK RHYTHM WAS SINUS BRADYCARDIA @ 30 BPM WITH PVC¿S. AT 16:47:29, THE PATIENT RECEIVED THE FIRST INAPPROPRIATE TREATMENT. NSVT CONTRIBUTED TO THE FALSE DETECTION. RHYTHM AT THE TIME OF TREATMENT WAS NSVT. POST SHOCK RHYTHM WAS SINUS BRADYCARDIA @ 30 BPM WITH PVC¿S BRADYCARDIA @ 50 BPM WITH PVC¿S AND CPR/MOTION ARTIFACT. AT 16:48:43, AN ARRHYTHMIA WAS DETECTED. ECG SHOWS VF WITH CPR/MOTION ARTIFACT. AT 16:49:13, THE PATIENT RECEIVED THE THIRD APPROPRIATE TREATMENT. RHYTHM AT THE TIME OF TREATMENT WAS VF WITH CPR/MOTION ARTIFACT. POST SHOCK RHYTHM WAS SINUS BRADYCARDIA @ 30 BPM WITH PVC¿S. AT 16:57:55, AN ARRHYTHMIA WAS DETECTED. ECG SHOWS NSVT. AT 16:58:53, THE PATIENT RECEIVED THE SECOND INAPPROPRIATE TREATMENT. NSVT CONTRIBUTED TO THE FALSE DETECTION. RHYTHM AT THE TIME OF TREATMENT WAS NSVT. POST SHOCK RHYTHM WAS SINUS BRADYCARDIA @ 30 BPM WITH PVC¿S BRADYCARDIA @ 50 BPM WITH PVC¿S AND CPR/MOTION ARTIFACT. THE ELECTRODE BELT WAS DISCONNECTED AT 16:59:37 ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2301302 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death