BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 8116602 · Received November 29, 2018

    Report

    Report Number
    3008642652-2018-09923
    Event Type
    Death
    Date Received
    November 29, 2018
    Date of Event
    October 16, 2018
    Report Date
    November 19, 2018
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. DURING THE INCOMING FUNCTIONAL TESTING, A 1HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE ECG ELECTRODES. THE PULSE DELIVERY CIRCUITRY TEST VERIFIED PROPER DELIVERY OF FULL ENERGY 150J BIPHASIC PULSE. THE FUNCTIONAL TESTING CONFIRMED PROPER ECG ACQUISITION AND PULSE DELIVERY FUNCTIONALITY. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. 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. AN OPEN R781 RESISTOR IS CONSISTENT WITH DAMAGE OBSERVED WHEN A PATIENT IS EXTERNALLY DEFIBRILLATED WHILE WEARING A LIFEVEST DEVICE. MONITOR SN (B)(4) MANUFACTURING DATE: 07/01/2016, ELECTRODE BELT SN (B)(4) MANUFACTURING DATE: 01/04/2012.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A (B)(6) PATIENT PASSED AWAY ON (B)(6) 2018 AT 6:25 PM. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS OCCLUSION OF THE LEFT MAIN CORONARY ARTERY. THE PATIENT WAS IN THE ICU AND WAS REPORTED TO BE WEARING THE DEVICE AT THE TIME OF PASSING. THE PATIENT WAS REPORTEDLY BEING MONITORED BY THE HOSPITAL AT THE TIME. REVIEW OF THE DOWNLOADED ECG DATA REVEALED THAT THE PATIENT RECEIVED TWO, NON-LIFEVEST DEFIBRILLATIONS PRIOR TO PASSING. PER THE DOWNLOADED ECG AND FLAG DATA, THE PATIENT WAS IN SINUS RHYTHM AT 70 BPM WITH NSVT AND MOTION ARTIFACT. THE RHYTHM THEN TRANSITIONED TO VENTRICULAR FIBRILLATION (VF) WITH MOTION ARTIFACT FOR 28 SECONDS BEFORE RECEIVING THE FIRST NON-LIFEVEST DEFIBRILLATION WHILE IN VF WITH MOTION ARTIFACT. THE POST-SHOCK RHYTHM WAS OBSCURED BY CPR ARTIFACT. THE RHYTHM THEN TRANSITIONED TO SINUS RHYTHM FROM 60 BPM TO 80 BPM WITH MOTION ARTIFACT. THE PATIENT WAS THEN IN VENTRICULAR TACHYCARDIA (VT) FOR 24 SECONDS BEFORE RECEIVING THE SECOND NON-LIFEVEST DEFIBRILLATION WHILE IN VT AT 160 BPM. THE POST SHOCK RHYTHM WAS VT AT 200 BPM SLOWING TO VT AT 150 BPM WITH MOTION ARTIFACT FROM APPROXIMATELY 17:46:00 UNTIL THE DEVICE SHUTDOWN AT 18:11:38 ON (B)(6) 2018. THE LIFEVEST PROPERLY DETECTED VT/VF, HOWEVER THE PATIENT WAS NOT IN THE DETECTION SEQUENCE LONG ENOUGH FOR THE LIFEVEST TO DELIVER A TREATMENT. IN ADDITION, THE PATIENT'S HEART RATE WAS AT OR BELOW THE THRESHOLD FOR TREATMENT DELIVERY. LASTLY, CPR ARTIFACT/MOTION ARTIFACT PREVENTED THE PATIENT FROM BEING TREATED BY THE LIFEVEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    954937 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death