BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 11514551 · Received March 18, 2021

    Report

    Report Number
    3008642652-2021-02147
    Event Type
    Death
    Date Received
    March 18, 2021
    Date of Event
    February 8, 2021
    Report Date
    March 16, 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. UPON INVESTIGATION THE MONITOR WAS NOT PROPERLY PRODUCING A DRIVEN GROUND SIGNAL. THE CAUSE FOR THE FAILURE WAS ISOLATED TO AN OPEN R781 DRIVEN GROUND RESISTOR ON THE COMPUTER/ANALOG BOARD. THE OPEN R781 RESISTOR IS CONSISTENT WITH A PATIENT RECEIVING AN EXTERNAL DEFIBRILLATION WHILE WEARING THE LIFEVEST. DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE ELECTRODE BELT ECG ACQUISITION AND PULSE DELIVERY CIRUCITRY WAS TESTED AND FOUND TO BE FULLY FUNCTIONAL. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. MANUFACTURE DATES: MONITOR: 9/15/2020; ELECTRODE BELT: 4/15/2020.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY ON THE MORNING OF (B)(6) 2021 WHILE WEARING THE LIFEVEST. THE PATIENT WAS REPORTEDLY IN AN AMBULANCE WITH EMS PRESENT AT THE TIME OF PASSING. REVIEW OF THE PATIENT'S DOWNLOAD DATA REVEALED THAT FROM 23:50:38 ON (B)(6) 2021 UNTIL 2:27:00 ON (B)(6) 2021, THE PATIENT WAS IN AN IDIOVENTRICULAR RHYTHM AT 40 BPM. THE RHYTHM THEN DEGRADED TO ASYSTOLE WITH CPR/MOTION ARTIFACT. THE RHYTHM TRANSITIONED AGAIN TO AN IDIOVENTRICULAR RHYTHM AT 80 BPM DEGRADING TO VENTRICULAR TACHYCARDIA (VT) AT 170 BPM. THE PATIENT REMAINED IN VT FOR 34 SECONDS WITH MOTION ARTIFACT AND ELECTRODE LEAD FALLOFF UNTIL AN EXTERNAL DEFIBRILLATION WAS DELIVERED TO THE PATIENT. THE PATIENT WAS NOT IN THE TREATABLE ARRHYTHMIA FOR LONG ENOUGH FOR THE LIFEVEST TO DELIVER A TREATMENT. THE LIFEVEST TYPICALLY REQUIRES 60 SECONDS OF SUSTAINED VT BEFORE A TREATMENT CAN BE DELIVERED. THE PATIENT'S CONTINUOUS ECG RECORDINGS THEN SHOWED CPR/MOTION ARTIFACT UNTIL THE RHYTHM DEGRADED TO ASYSTOLE WITH MOTION ARTIFACT/ELECTRODE LEAD FALL OFF. THE FALLOFF SIGNAL WAS LOST ON ALL ELECTRODES AFTER THE EXTERNAL DEFIBRILLATION AND DID NOT RETURN DUE TO THE LOSS OF A DRIVEN GROUND SIGNAL. THIS IS CONSISTENT WITH EXTERNAL DEFIBRILLATIONS. WHEN THE FALLOFF SIGNAL IS LOST THE DEVICE IS ABLE TO CONTINUE RECORDING AN ECG OF THE PATIENT'S HEART RHYTHM, HOWEVER THE DEVICE IS NO LONGER ABLE TO TREAT THE PATIENT. THERE IS NO INDICATION THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE PATIENT'S PASSING AS THE DEVICE WAS FUNCTIONING APPROPRIATELY PRIOR TO THE DELIVERY OF THE EXTERNAL DEFIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412891 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O