BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4649065 · Received March 27, 2015

    Report

    Report Number
    3008642652-2015-01689
    Event Type
    Death
    Date Received
    March 27, 2015
    Date of Event
    February 12, 2015
    Report Date
    March 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

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) AND MONITOR SN (B)(4) ARE COMPLETE. AS RECEIVED, THE ELECTRODE BELT AND MONITOR WERE FULLY FUNCTIONAL AND ABLE TO DETECT AND TREAT. MONITOR (B)(4) - 06/2011 (REUSE), ELECTRODE BELT (B)(4) - 03/2012 (REUSE).

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A (B)(6) YEAR OLD MALE PT PASSED AWAY (B)(6) 2015 WHILE NOT WEARING THE LIFEVEST. THE PASSING WAS CARDIAC AND STROKE RELATED. THE PT HAD NOT USED THE LIFEVEST SINCE (B)(6) 2014 DUE TO ORES THAT DEVELOPED UNDERNEATH THE DEVICE. THERE IS NO INDICATION THAT THE PT SOUGHT MEDICAL ATTENTION FOR THE SORES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205193 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death