BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 11645932 · Received April 9, 2021

    Report

    Report Number
    3008642652-2021-02972
    Event Type
    Death
    Date Received
    April 9, 2021
    Date of Event
    January 28, 2021
    Report Date
    April 7, 2021
    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 MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON INVESTIGATION THE MONITOR FAILED INCOMING FUNCTIONAL TESTING. 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 THE 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 CIRCUITRY WAS TESTED AND FOUND TO BE FULLY FUNCTIONAL. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. DEVICE MANUFACTURE DATE: MONITOR 04/06/2015; BELT 06/23/2020.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT RECEIVED A TREATMENT FROM THE LIFEVEST WHILE AT HOME. EMS WAS CALLED AND THE PATIENT WAS TAKEN TO THE HOSPITAL BEFORE PASSING AWAY. IT WAS REPORTED THAT THE PATIENT'S FAMILY AND EMS PERFORMED RESUSCITATION EFFORTS. PER CLINICAL REVIEW OF THE CONTINUOUS ECG RECORDING, THE DEVICE WAS STARTED UP AT 00:26:22 ON (B)(6) 2021. THE PATIENT WAS IN SVT AT 170 BPM, WHEN THEIR RHYTHM DEGRADED TO VF AT 01:37:43. AN ARRHYTHMIA WAS DETECTED WHILE THE PATIENT WAS IN VF AT 01:38:09. THE RESPONSE BUTTONS WERE USED INTERMITTENTLY, DELAYING THE DELIVERY OF A TREATMENT WHILE THE PATIENT WAS IN VF. IT WAS NOT REPORTED WHO WAS PRESSING THE RESPONSE BUTTONS. THE PATIENT RECEIVED AN APPROPRIATE TREATMENT AT 01:40:09 DURING VF. THE PATIENT'S POST-SHOCK RHYTHM WAS AN IDIOVENTRICULAR RHYTHM AT 100 BPM. THE PATIENT RECEIVED A SECOND APPROPRIATE TREATMENT DURING VF AT 01:42:13. THE PATIENT'S POST-SHOCK RHYTHM WAS VT AT 160 BPM. THE PATIENT'S RHYTHM THEN TRANSITIONED TO ASYSTOLE WITH OCCASIONAL CARDIAC ACTIVITY. THE PATIENT RECEIVED AN INAPPROPRIATE TREATMENT AT 01:42:47 DURING ASYSTOLE. THE INAPPROPRIATE TREATMENT INDUCED VT AT 180 BPM. THE PATIENT RECEIVED AN APPROPRIATE TREATMENT AT 01:43:22. THE PATIENT'S RHYTHM AT THE TIME OF TREATMENT AND POST-SHOCK RHYTHM WERE VT AT 180 BPM. THE PATIENT RECEIVED AN APPROPRIATE TREATMENT AT 01:43:57 DURING VF. THE PATIENT'S POST-SHOCK RHYTHM WAS ASYSTOLE WITH INTERMITTENT CARDIAC ACTIVITY. THE PATIENT RECEIVED AN INAPPROPRIATE TREATMENT DURING ASYSTOLE WITH INTERMITTENT CARDIAC ACTIVITY AT 01:44:26. THE PATIENT'S POST-SHOCK RHYTHM WAS VF. CPR/MOTION ARTIFACT AND ELECTRODE LEAD FALL OFF PREVENTED FURTHER DETECTION OF THE VF ARRHYTHMIA. THE PATIENT RECEIVED A NON-LIFEVEST DEFIBRILLATION AT 02:00:38 DURING VF. THE PATIENT'S POST-SHOCK RHYTHM WAS OBSCURED BY ELECTRODE LEAD FALL OFF. A SECOND NON-LIFEVEST DEFIBRILLATION OCCURRED AT 02:01:11. THE PATIENT'S RHYTHM AT THE TIME OF TREATMENT, AND POST-SHOCK RHYTHM WERE OBSCURED BY ELECTRODE LEAD FALL OFF. THE PATIENT WAS IN VF WITH CPR/MOTION ARTIFACT AT 02:11:34 UNTIL 02:26:23. CPR/MOTION ARTIFACT AND ELECTRODE LEAD FALL OFF PREVENTED THE LIFEVEST FROM DETECTING THE ARRHYTHMIA. THE PATIENT RECEIVED A THIRD NON-LIFEVEST DEFIBRILLATION DURING VF AT 02:26:23. THE PATIENT'S POST-SHOCK RHYTHM WAS ASYSTOLE WHICH TRANSITIONED TO BRADYCARDIA AT 40 BPM WITH CPR/MOTION ARTIFACT AT 02:27:22. THE PATIENT RECEIVED A FOURTH NON-LIFEVEST DEFIBRILLATION AT 02:32:31 DURING VF. THE PATIENT'S POST-SHOCK RHYTHM WAS ASYSTOLE, TRANSITIONING TO BRADYCARDIA AT 20 BPM. ELECTRODE LEAD FALL OFF AND CPR/MOTION ARTIFACT OBSCURED THE PATIENT'S RHYTHM UNTIL AN IDIOVENTRICULAR RHYTHM AT 40 TO 50 BPM CAN BE SEEN AT APPROXIMATELY 02:41:00. THE PATIENT WAS IN AN IDIOVENTRICULAR RHYTHM AT 40 TO 50 BPM WITH CPR/MOTION ARTIFACT AND ELECTRODE LEAD FALL OFF UNTIL THE DEVICE WAS SHUTDOWN AT 02:48:49 ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536810 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death