BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 5237601 · Received November 19, 2015

    Report

    Report Number
    3008642652-2015-07589
    Event Type
    Death
    Date Received
    November 19, 2015
    Date of Event
    October 14, 2015
    Report Date
    November 18, 2015
    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 ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (PATIENT DEATH) WAS CONFIRMED. 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: 10/25/2013, ELECTRODE BELT: 03/06/2013.

    Description of Event or Problem · 1

    A DISTRIBUTOR NOTIFIED ZOLL ON (B)(6) 2015 THAT A PATIENT PASSED AWAY ON (B)(6) 2015 AROUND 12:15AM. THE PATIENT RECEIVED TWO TREATMENT SHOCKS PRIOR TO PASSING. THE PATIENT WAS REPORTED TO BE AT HOME WITH HIS WIFE AT THE TIME OF THE EVENT. THE PATIENT'S WIFE REPORTED THAT EMS WAS PRESENT AT THE TIME OF THE SECOND TREATMENT. THE FIRST APPROPRIATE TREATMENT WAS DELIVERED AT 12:50:38AM ON (B)(6) 2015. THE RHYTHM AT THE TIME OF THE TREATMENTS WAS VF. THE POST SHOCK RHYTHM OF THE TREATMENT WAS ASYSTOLE. POST-SHOCK ASYSTOLE IS A KNOWN AND POTENTIALLY ADVERSE OUTCOME OF DEFIBRILLATION THERAPY. THE PATIENT WAS TREATED A SECOND TIME AT 12:51:09AM. THE RHYTHM AT THE TIME OF THE TREATMENT WAS CPR ARTIFACT. CPR ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. THE ECG RECORDING SHOWED THAT THE PATIENT WAS IN ASYSTOLE PRIOR TO DEVICE DEACTIVATION AT 12:58:04AM ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765164 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death