BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 10701463 · Received October 19, 2020

    Report

    Report Number
    3008642652-2018-05785
    Event Type
    Death
    Date Received
    October 19, 2020
    Date of Event
    May 17, 2018
    Report Date
    June 27, 2018
    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. THE REPORTED PROBLEM (PATIENT DEATH/TREATMENT) WAS CONFIRMED. UPON INVESTIGATION THE MONITOR WAS FULLY FUNCTIONAL AND PASSED INCOMING FUNCTIONAL TESTING. DURING THE INCOMING FUNCTIONAL TESTING, A 1HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE DEVICE, FOLLOWED BY A 5HZ SIMULATED TREATABLE ARRHYTHMIA SIGNAL WHICH VERIFIED PROPER PERFORMANCE OF THE DETECTION ALGORITHM. DURING THE TRANSITION TO THE 5HZ SIGNAL, THE DEVICE WAS CONFIRMED TO PROPERLY ENTER INTO A TREATMENT SEQUENCE WHICH INCLUDES A VERIFICATION OF THE TACTILE VIBRATION ALARM, AUDIO MESSAGING, AND SIREN ALARMS, AS WELL AS A TEST OF THE PULSE DELIVERY CIRCUITRY. THE PULSE DELIVERY CIRCUITRY TEST VERIFIED PROPER CHARGING OF THE HIGH VOLTAGE CAPACITORS AND PROPER DELIVERY OF FIVE FULL ENERGY 150J BIPHASIC PULSES. THE FUNCTIONAL TESTING CONFIRMED PROPER RESPONSE BUTTON FUNCTIONALITY, ECG ACQUISITION, DETECTION ALGORITHM PERFORMANCE, AND PULSE DELIVERY FUNCTIONALITY OF THE MONITOR. DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (PATIENT DEATH/TREATMENT) WAS CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT WAS FULLY FUNCTIONAL AND PASSED INCOMING FUNCTIONAL TESTING OF THE DEVICE'S ECG ACQUISITION AND PULSE DELIVERY CIRCUITRY.

    Description of Event or Problem · 1

    ON 10/16/2020: RESUBMITTING THIS MDR AS PART OF AN INTERNAL AUDIT WHERE THE ELECTRONIC 3500A PDF FORM COULD NOT BE LOCATED. THE INTERNAL AUDIT INDICATES THAT THE ELECTRONIC 3500A FORM, WITHIN THE ESUBMITTER APPLICATION, WAS CREATED ON 6/27/2018. ACKNOWLEDGEMENTS 1, 2, AND 3 COULD NOT BE LOCATED. A US DISTRIBUTOR REPORTED THAT A PATIENT PASSED AWAY ON (B)(6) 2018 WHILE IN THE HOSPITAL. PRIOR TO PASSING, THE PATIENT RECEIVED AN INAPPROPRIATE TREATMENT EVENT CONSISTING OF ONE SHOCK. THE PATIENT WAS ALONE IN A HOSPITAL ROOM AT THE TIME OF THE EVENT. RESUSCITATION EFFORTS WERE MADE ON THE PATIENT. AT 23:55:18 ON (B)(6) 2018 THE PATIENT WAS TREATED WHILE IN ATRIAL FLUTTER WITH CPR ARTIFACT. THE POST-SHOCK RHYTHM WAS POLYMORPHIC ATRIAL FIBRILLATION AT 60 BPM. FOLLOWING THE TREATMENT, THE PATIENT DEGRADED TO ASYSTOLE. THE PATIENT REMAINED IN ASYSTOLE WITH INTERMITTENT CARDIAC ACTIVITY AND CPR ARTIFACT UNTIL DEVICE DEACTIVATION AT 00:14:00 ON (B)(6) 2018. THE PATIENT PASSED AWAY ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159872 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death