BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6345450 · Received February 21, 2017

    Report

    Report Number
    3008642652-2017-01477
    Event Type
    Death
    Date Received
    February 21, 2017
    Date of Event
    December 31, 2016
    Report Date
    February 20, 2017
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    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 SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) AND BELT SN (B)(4) HAS BEEN COMPLETED. THE EVALUATION INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAY OF THE EVENT AND INCOMING FUNCTIONAL TESTING. THE REVIEW OF THE SOFTWARE FLAGS CONSISTED OF AN ANALYSIS OF THE DOWNLOADED DATA TO IDENTIFY ANY FAULT FLAGS OR UNUSUAL PATTERNS OF SOFTWARE FLAGS. THE SOFTWARE FLAG FILES DID NOT SUGGEST A DEVICE MALFUNCTION THAT WOULD CONTRIBUTE TO THE EVENT. DURING THE INCOMING FUNCTIONAL TESTING, A 1HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE ECG ELECTRODES, 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. DEVICE MANUFACTURE DATE: MONITOR: 06/25/2013; BELT: 06/17/2014.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY. THERE ARE NO AVAILABLE DETAILS SURROUNDING THE EVENT. REVIEW OF THE DOWNLOAD DATA INDICATES THAT THE LIFEVEST DETECTED AN ARRHYTHMIA ON (B)(6) 2016 FROM 8:49:39 TO 8:55:00. THE PATIENT'S ECG SHOWED SINUS RHYTHM/BRADYCARDIA WITH VARYING RATE FROM 30 TO 70BPM, AS WELL AS PERIODS OF NON-SUSTAINED VF. ANOTHER ARRHYTHMIA WAS DETECTED AT 8:55:43. THE PATIENT'S ECG SHOWED ASYSTOLE WITH PERIODS OF VF. A TREATMENT SHOCK WAS DELIVERED AND THE PATIENT WAS IN ASYSTOLE AT THE TIME OF THE SHOCK. THE POST-SHOCK RHYTHM WAS AGAIN ASYSTOLE WITH PERIODS OF VF. A SECOND SHOCK WAS DELIVERED DURING VF. THE PATIENT REMAINED IN VF. THREE FINAL SHOCKS WERE DELIVERED DURING ASYSTOLE WITH PERIODS OF VF. THE RHYTHM AFTER THE SHOCKS WAS ASYSTOLE WITH PERIODS OF VF. THE DEVICE THEN DETECTED A NON-TREATABLE RHYTHM AND THE DEVICE WAS SHUTDOWN AT 9:38:31. THE INTERMITTENT VF CONTRIBUTED TO ALL DETECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127632 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death