BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYS

    MDR report key: 4192739 · Received October 14, 2014

    Report

    Report Number
    3008642652-2014-03203
    Event Type
    Death
    Date Received
    October 14, 2014
    Date of Event
    September 7, 2014
    Report Date
    October 14, 2014
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    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 ELECTRODE BELT SN (B)(4) IS COMPLETE. AS RECEIVED, THE ELECTRODE BELT WAS FULLY FUNCTIONAL AND ABLE TO DETECT AND TREAT. MONITOR SN (B)(4) HAS NOT YET BEEN RETURNED TO ZOLL FOR INVESTIGATION. NO DATA DOWNLOAD HAS BEEN ABLE TO BE COMPLETED. THE LIFEVEST IS CONTRA-INDICATED WITH ICDS. ELECTRODE BELT SN(B)(4): (B)(6) 2009; MONITOR SN (B)(4): 10(B)(6) 2013.

    Description of Event or Problem · 1

    A UNITED STATES DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PT PASSED AWAY ON (B)(6) 2014, AT 4:58 AM. THE PT STARTED CODING, WENT INTO VF, AND WAS UNRESPONSIVE WHILE WEARING THE LIFEVEST. THE PT'S NURSE DID NOT HEAR THE DEVICE ALARMING. THE PT WAS BEING MONITORED BY HOSPITAL TELEMETRY. THE NURSE REPORTED THAT THE PT'S AICD WAS FIRING, AND HOSPITAL STAFF USED A MAGNET TO DEACTIVATE THE ICD. THE LIFEVEST IS CONTRA-INDICATED WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATORS. NO DATA DOWNLOAD OF THE PT'S MONITOR HAS BEEN ABLE TO BE COMPLETED FOR THE DATE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650180 LIFEVEST WCD 4000 SYS WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death