BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6122562 · Received November 22, 2016

    Report

    Report Number
    3008642652-2016-08635
    Event Type
    Death
    Date Received
    November 22, 2016
    Date of Event
    September 2, 2016
    Report Date
    November 22, 2016
    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 OF MONITOR SN (B)(4) HAS BEEN COMPLETED. 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. ELECTRODE BELT SN (B)(4) HAS NOT YET BEEN RECOVERED FROM THE EVENT. A REVIEW OF DEVICE DOWNLOAD DATA DOES NOT SUGGEST ANY ELECTRODE BELT MALFUNCTION CAUSING OR CONTRIBUTING TO THE EVENT.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT THE PATIENT WAS TREATED BY THE LIFEVEST AND PASSED AWAY ON (B)(6) 2016. THE PATIENT WAS HOME ALONE AT THE TIME OF THE EVENT. THE LIFEVEST DETECTED AN ARRHYTHMIA (VF) AT 03:34:39 AND RELEASED CONDUCTIVE GEL. THE LIFEVEST DELIVERED A TREATMENT AT 03:35:33. THE VF SELF-CONVERTED TO AN IDIOVENTRICULAR RHYTHM APPROXIMATELY 2 SECONDS PRIOR TO THE TREATMENT. THE POST-SHOCK RHYTHM WAS ASYSTOLE. POST-SHOCK ASYSTOLE IS A KNOWN POTENTIAL OUTCOME OF DEFIBRILLATION. THE RHYTHM CONVERTED TO AN IDIOVENTRICULAR RHYTHM (60 BPM) APPROXIMATELY 13 SECONDS AFTER THE TREATMENT. AT 08:48:57 THE PATIENT'S RHYTHM DEGRADED TO ASYSTOLE. ASYSTOLE IS CONSIDERED A NON-TREATABLE RHYTHM. THE LIFEVEST BATTERY WAS REMOVED FROM THE DEVICE AT 08:59:02. IT IS UNKNOWN WHO REMOVED THE BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770990 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death