BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 10410866 · Received August 14, 2020

    Report

    Report Number
    3008642652-2017-00065
    Event Type
    Death
    Date Received
    August 14, 2020
    Date of Event
    November 25, 2016
    Report Date
    January 4, 2017
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE MONITOR 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 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. . BASED ON THE DOWNLOADED SOFTWARE FLAGS, THERE IS NO EVIDENCE TO SUGGEST THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH. 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 A FULL ENERGY 150J BIPHASIC PULSE. THE FUNCTIONAL TESTING CONFIRMED PROPER ECG ACQUISITION AND PULSE DELIVERY FUNCTIONALITY. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION THAT CAUSED OR CONTRIBUTED TO THE PATIENT DEATH.

    Description of Event or Problem · 1

    8/14/2020: RESUBMITTING THIS MDR AS PART OF AN INTERNAL AUDIT WHICH INDICATED THAT ACKNOWLEDGEMENT 1 AND 2 WERE RECEIVED, HOWEVER DUE TO A TYPOGRAPHICAL ERROR IN THE REPORT NUMBER, WHICH DOCUMENTED THIS AS A 2016 REPORT WHEN IT WAS ACTUALLY A 2017 REPORT, THE MDR SUBMISSION FAILED AS A DUPLICATE REPORT. THE REPORT NUMBER WAS CORRECTED, AND IS BEING RESUBMITTED. A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT THE PATIENT PASSED AWAY ON (B)(6) 2016. IT WAS REPORTED THE PATIENT WAS IN A RESTAURANT AND LOST CONSCIOUSNESS. THE PATIENT REPORTEDLY GAINED CONSCIOUSNESS AFTER THE FIRST TREATMENT. EMERGENCY SERVICES WERE CALLED AND THE PATIENT PASSED AWAY. THE PATIENT RECEIVED FIVE APPROPRIATE TREATMENTS ON (B)(6) 2016 BETWEEN 14:56:04 AND 15:05:11. THE RHYTHM AT THE TIME OF TREATMENT WAS VF. THE POST SHOCK RHYTHM WAS SUCCESSFULLY CONVERTED TO A SLOWER RHYTHM. THE PATIENT RECEIVED ONE INAPPROPRIATE TREATMENT AT 15:07:06. THE RHYTHM AT THE TIME OF THE TREATMENT WAS NSVT AT 245 BPM. THE POST SHOCK RHYTHM WAS SINUS TACHYCARDIA WITH NSVT AT 180 BPM TRANSITIONING TO VF. THE RAPID RATE CONTRIBUTED TO THE FALSE DETECTION. THE RESPONSE BUTTONS WERE PRESSED INTERMITTENTLY THROUGHOUT THE EVENT. IT IS UNKNOWN WHO PRESSED THE RESPONSE BUTTONS. THE ELECTRODE BELT WAS DISCONNECTED AT 03:07:43 WHILE THE PATIENT WAS IN VF. THE DEVICE WAS SHUTDOWN AT 16:01:47.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    874924 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death