BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 8646901 · Received May 28, 2019

    Report

    Report Number
    3008642652-2019-03924
    Event Type
    Death
    Date Received
    May 28, 2019
    Date of Event
    April 28, 2019
    Report Date
    May 21, 2019
    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 SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) AND ELECTRODE 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. 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. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. MANUFACTURE DATE: MONITOR: 12/01/2015; ELECTRODE BELT: 05/04/2012.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A (B)(6) PATIENT EXPERIENCED A DEFIBRILLATION EVENT CONSISTING OF ONE SHOCK. THE PATIENT RECEIVED AN INAPPROPRIATE TREATMENT AT 4:58 AM ON (B)(6) 2019 WHILE IN SUPRAVENTRICULAR TACHYCARDIA (SVT) AT 170 BPM WITH PVC'S AND MOTION ARTIFACT. THE POST-SHOCK RHYTHM WAS SINUS TACHYCARDIA AT 130 BPM WITH PVC'S AND MOTION ARTIFACT. IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL AT THE TIME OF THE TREATMENT EVENT. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE EVENT. SVT CONTRIBUTED TO THE FALSE DETECTION. THE DEVICE WAS LAST SHUTDOWN AT 11:13:55 ON (B)(6) 2019. THE PATIENT LATER PASSED AWAY EARLY IN THE MORNING AROUND 1:00 AM ON (B)(6) 2019, AND WAS NOT WEARING THE LIFEVEST AT THE TIME OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441350 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| H| O