BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 7133162 · Received December 20, 2017

    Report

    Report Number
    3008642652-2017-10637
    Event Type
    Death
    Date Received
    December 20, 2017
    Date of Event
    September 17, 2017
    Report Date
    December 18, 2017
    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 ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. ALL GELS WERE DEPLOYED. DURING THE INCOMING FUNCTIONAL TESTING, A 1 HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE ECG ELECTRODES. THE PULSE DELIVERY CIRCUITRY TEST VERIFIED PROPER DELIVERY OF FULL ENERGY 150J BIPHASIC PULSE. THE FUNCTIONAL TESTING CONFIRMED PROPER ECG ACQUISITION AND PULSE DELIVERY FUNCTIONALITY. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. MONITOR SN (B)(4) WAS RETURNED FOR EVALUATION. THE EVALUATION IS STILL UNDERWAY. AN INITIAL EVALUATION CONSISTED OF A REVIEW OF THE DOWNLOADED SOFTWARE FLAG FILES ON THE DAY OF THE EVENT. 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.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT HAD PASSED AWAY ON (B)(6) 2017 WHILE WEARING THE LIFEVEST. THE PATIENT WAS AT HOME AT THE TIME OF THE EVENT WHICH OCCURRED BETWEEN 12:30 - 1:30 AM, PER THE PATIENT'S WIFE. THE PATIENT'S WIFE REPORTED THAT THE PATIENT LOST CONSCIOUSNESS AND THAT THE PATIENT WAS NOT SHOCKED BUT THE DEVICE DID ALARM TO CALL FOR HELP AND PERFORM CPR. CPR WAS PERFORMED AND PARAMEDICS WERE CALLED. THE PARAMEDICS CONTINUED CPR DURING TRANSPORT TO THE HOSPITAL AND REPORTEDLY EXTERNALLY DEFIBRILLATED THE PATIENT. PER REVIEW OF THE DOWNLOADED ECG AND FLAG DATA, PRIOR TO PASSING, THE PATIENT RECEIVED TWO DEFIBRILLATION SHOCKS FROM THE LIFEVEST. AT 01:46:39 ON (B)(6) 2017 THE DEVICE DETECTED AN ARRHYTHMIA. THE ECG RECORDING REVEALED VARIABLE AMPLITUDE VF WITH MOTION ARTIFACT. AN APPROPRIATE TREATMENT WAS DELIVERED AT 01:47:19 AM APPROPRIATE DEFIBRILLATION. THE POST-SHOCK RHYTHM WAS ASYSTOLE. A SECOND DEFIBRILLATION SHOCK FROM THE LIFEVEST WAS DELIVERED AT 01:49:09. THE RHYTHM AT THE TIME OF THE TREATMENT WAS ASYSTOLE. INTERMITTENT CARDIAC ACTIVITY AND ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. THE PATIENT REMAINED IN ASYSTOLE FOLLOWING THE TREATMENT. THE DEVICE PROPERLY DETECTED AND ALARMED FOR THE ASYSTOLE FOLLOWING THE TREATMENT EVENTS. CPR ARTIFACT AND INTERMITTENT CARDIAC ACTIVITY WAS VISIBLE ON THE ECG STRIPS. THE ELECTRODE BELT WAS DISCONNECTED AT 02:04:42 AM. POST-SHOCK ASYSTOLE IS A KNOWN POTENTIAL OUTCOME OF DEFIBRILLATION. THERE IS NO INDICATION OF A DEVICE MALFUNCTION CONTRIBUTING TO THE PATIENT DEATH AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915700 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death