BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 10701447 · Received October 19, 2020

    Report

    Report Number
    3008642652-2018-05786
    Event Type
    Death
    Date Received
    October 19, 2020
    Date of Event
    May 25, 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. DURING THE INCOMING FUNCTIONAL TESTING, A 1HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE MONITOR, 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 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. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. 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 AT A SKILLED NURSING FACILITY. PRIOR TO PASSING, THE PATIENT RECEIVED AN INAPPROPRIATE TREATMENT EVENT CONSISTING OF SIX SHOCKS. IT WAS REPORTED THAT THE PATIENT WAS FOUND UNRESPONSIVE AND THAT RESUSCITATION EFFORTS WERE MADE. AT 23:04:50 ON (B)(6) 2018 THE PATIENT WENT INTO ASYSTOLE. AN ARRHYTHMIA WAS DETECTED, AND THE PATIENT WAS SUBSEQUENTLY TREATED SIX TIMES WHILE IN ASYSTOLE WITH CPR ARTIFACT. THE POST-SHOCK RHYTHMS FOR THE SIX TREATMENTS WAS ASYSTOLE WITH CPR ARTIFACT. CPR ARTIFACT CONTRIBUTED TO THE FALSE DETECTIONS. THE PATIENT DEVICE WAS REMOVED SHORTLY AFTER AT 23:11:06 WHILE THE PATIENT WAS IN ASYSTOLE. THERE IS NO INDICATION OR ALLEGATION TO SUGGEST THAT THE DEVICE CONTRIBUTED TO THE PATIENT'S DEATH AS THE PATIENT WAS IN ASYSTOLE PRIOR TO THE TREATMENT EVENT. ASYSTOLE IS CONSIDERED A NON-TREATABLE, NON-LIFE SUSTAINING RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159869 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death