BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 5480973 · Received March 4, 2016

    Report

    Report Number
    3008642652-2016-01248
    Event Type
    Death
    Date Received
    March 4, 2016
    Date of Event
    May 9, 2015
    Report Date
    March 3, 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 EVALUTION SUMMARY: THE MONITOR SN (B)(4) AND BELT SN (B)(4) WERE RETURNED AND EVALUATED BY ZOLL MANUFACTURING CORPORATION. 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 PATIENT DEATH. 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: 11/25/2013; ELECTRODE BELT: 03/21/2013.

    Description of Event or Problem · 1

    ZOLL WAS NOTIFIED BY A US DISTRIBUTOR THAT A PATIENT PASSED AWAY ON (B)(6) 2015. NO ADDITIONAL DETAILS ABOUT THE PATIENT DEATH WERE REPORTED. PER REVIEW OF THE PATIENT'S DOWNLOADED FLAG AND ECG FILES, AT 07:22:41 AM THE PATIENT WENT INTO VF. THE RESPONSE BUTTONS WERE PRESSED INTERMITTENTLY BETWEEN 07:22:55 AND 07:23:19 AND AN APPROPRIATE TREATMENT WAS DELIVERED AT 07:24:09 AM. THE RHYTHM AT THE TIME OF THE TREATMENT WAS VF. THE POST-SHOCK RHYTHM WAS AN IDIOVENTRICULAR RHYTHM AT 60 BPM. AT 07:27:14 AND 07:27:53 THE DEVICE DELIVERED TWO ADDITIONAL TREATMENTS WHILE THE PATIENT WAS IN AN IDIOVENTRICULAR RHYTHM AT 60 - 65 BPM WITH TALL T WAVES. MULTIPLE COUNTING OF THE TALL T WAVES CONTRIBUTED TO THE FALSE DETECTIONS. THE PATIENT'S RHYTHM REMAINED AN IDIOVENTRICULAR RHYTHM FOLLOWING BOTH TREATMENTS. BETWEEN 07:33:45 AND 07:38:22 THE DEVICE DETECTED AND ALARMED FOR ASYSTOLE THREE TIMES. THE ECG RECORDING SHOWS THAT THE PATIENT WAS IN AN IDIOVENTRICULAR DEGRADING TO ASYSTOLE. ASYSTOLE IS CONSIDERED A NON-SHOCKABLE RHYTHM. THE DEVICE WAS DEACTIVED AT 07:42:01 AM AND THE PATIENT SUBSEQUENTLY PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135802 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death