BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4827850 · Received June 5, 2015

    Report

    Report Number
    3008642652-2015-03674
    Event Type
    Death
    Date Received
    June 5, 2015
    Date of Event
    April 18, 2015
    Report Date
    June 4, 2015
    Manufacturer
    ZOLL MANUFACTURING CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) WAS COMPLETED. THE MONITOR AND ELECTRODE BELT WERE FOUND TO BE FULLY FUNCTIONAL. THERE WAS NO DEVICE MALFUNCTION. THERE IS NO INDICATION THAT THE TREATMENTS DURING ASYSTOLE CAUSED OR CONTRIBUTED TO THE PT DEATH. NO VENTRICULAR ARRHYTHMIAS WERE DETECTED BY THE LIFEVEST. USAGE: MONITOR SN (B)(4): 06/01/2011. ELECTRODE BELT SN (B)(4): 07/01/2014.

    Description of Event or Problem · 1

    A DISTRIBUTOR NOTIFIED ZOLL THAT A (B)(6) FEMALE PT PASSED AWAY WHILE AT HOME ON (B)(6) 2015. THE LIFEVEST DELIVERED THREE TREATMENTS AT 06:08:18, 06:08:47, AND 06:09:14. THE RHYTHM AT THE TIME OF THE TREATMENTS WAS ASYSTOLE. ASYSTOLE IS CONSIDERED A NON-TREATABLE RHYTHM. OVERSENSING OF SMALL CARDIAC SIGNAL AND INTERMITTENT CARDIAC ACTIVITY CONTRIBUTED TO THE FALSE DETECTIONS. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE EVENT. THE PT SUBSEQUENTLY PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366145 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death