BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4564583 · Received February 27, 2015

    Report

    Report Number
    3008642652-2015-01034
    Event Type
    Death
    Date Received
    February 27, 2015
    Date of Event
    January 24, 2015
    Report Date
    February 26, 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

    THE PT'S DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. INITIAL DEVICE EVALUATION WAS ACCOMPLISHED THROUGH A REVIEW OF THE PT'S DOWNLOADED DATA FILE. REVIEW OF THE DATA DOES NOT INDICATE ANY DEVICE MALFUNCTION RELATED TO THE EVENT. MONITOR (B)(4): 11/2014 - INITIAL USE, ELECTRODE BELT (B)(4): 12/2013 - REUSE.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL ON (B)(6) 2015 TO REPORT THAT A PT PASSED AWAY WHILE WEARING THE LIFEVEST. THE PT WAS REPORTEDLY UNCONSCIOUS AT THE TIME OF THE EVENT. THE PT'S WIFE WAS WITH THE PT AND NOTIFIED EMS WHO INITIATED CPR. REVIEW OF THE PT'S DOWNLOADED DATA INDICATES THAT THE PT EXPERIENCED AN APPROPRIATE DEFIBRILLATION EVENT CONSISTING OF THREE SHOCKS AND A NON-LIFEVEST DEFIBRILLATION. THE LIFEVEST DETECTED VF AT 23:59:44 ON (B)(6) 2015 AND THE PT RECEIVED A SHOCK AT 00:00:20 ON (B)(6) 2015. THE PT'S VF WAS NOT CONVERTED BY THE FIRST SHOCK. THE SECOND SHOCK CONVERTED VF TO ASYSTOLE AND THE THIRD SHOCK CONVERTED VF TO BRADYCARDIA AT 22BPM. THE NON-LIFEVEST DEFIBRILLATION CONVERTED VF TO A SINUS RHYTHM AT 66BPM. THE LIFEVEST DETECTED A NON-TREATABLE RHYTHM APPROXIMATELY 28 SECONDS LATER. THE PT WAS TRANSPORTED TO THE HOSPITAL WHERE HE PASSED AWAY ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140503 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILALTOR MVK ZOLL MANUFACTURING CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death| H| O