BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3900295 · Received June 18, 2014

    Report

    Report Number
    3008642652-2014-01880
    Event Type
    Death
    Date Received
    June 18, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 17, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) HAVE NOT YET BEEN RETURNED TO ZOLL. THE LAST DATA FLAG IN THE MORNING OF (B)(6) 2014. REVIEW OF THE PATIENT'S FLAGS UNTIL THIS TIME INDICATED THAT THE EQUIPMENT WAS FULLY FUNCTIONAL AND DOES NOT REVEAL AN INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S PASSING. BELT MFR DATE: 04/01/2011. EQUIPMENT NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    A (B)(4) YEAR OLD MALE PATIENT'S WIFE CONTACTED ZOLL ON (B)(6) 2014 TO REPORT THAT THE PATIENT PASSED ON (B)(6) 2014. THE PATIENT WAS REPORTED TO HAVE BEEN IN A CAR ACCIDENT WHILE WEARING THE LIFEVEST. THERE ARE NO ALLEGED DEFICIENCIES AGAINST THE DEVICE AND NO ADDITIONAL DETAILS WERE ABLE TO HAVE BEEN OBTAINED. THE PATIENT'S MONITOR AND ELECTRODE BELT HAVE NOT YET BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358044 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death