BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4564587 · Received February 27, 2015

    Report

    Report Number
    3008642652-2015-01036
    Event Type
    Death
    Date Received
    February 27, 2015
    Date of Event
    January 13, 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): 10/2014, ELECTRODE BELT (B)(4): 09/2013.

    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 ON (B)(6) 2015. THE PT WAS REPORTEDLY UNCONSCIOUS LAYING ON THE FLOOR. THE PT'S DAUGHTER FOUND THE PT. REVIEW OF THE PT'S DOWNLOADED DATA INDICATES THAT THE PT EXPERIENCED AN APPROPRIATE DEFIBRILLATION EVENT CONSISTING OF THREE APPROPRIATE SHOCKS AND ONE OTHER SHOCK. THE LIFEVEST DETECTED VF AT 07:22:22 AND THE PT RECEIVED A SHOCK AT 07:22:58. THE PT'S VF WAS CONVERTED TO BRADYCARDIA AFTER THE FIRST AND THIRD SHOCKS. THE VF WAS CONVERTED TO VT AT 250BPM AFTER THE SECOND SHOCK. THE PT RECEIVED A FOURTH SHOCK DURING BRADYCARDIA. THE PT'S RHYTHM REMAINED IN BRADYCARDIA. THE LIFEVEST DETECTED A NON-TREATABLE RHYTHM APPROXIMATELY 16 SECONDS LATER. THE PT PASSED AWAY (B)(6)2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140886 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| O