BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4922666 · Received July 17, 2015

    Report

    Report Number
    3008642652-2015-04496
    Event Type
    Death
    Date Received
    July 17, 2015
    Date of Event
    June 15, 2015
    Report Date
    July 17, 2015
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE MONITOR WAS FULLY FUNCTIONAL AND WAS ABLE TO DETECT AND TREAT AN ARRYTHMIA. THE PATIENT'S DOWNLOADED FLAG DATA CONFIRMED THAT AN APPROPRIATE DEFIBRILLATION TREATMENT WAS ADMINISTERED TO THE PATIENT. ADDITIONALLY, A SERIES OF BELT COMMUNICATION ERRORS OCCURRED STARTING 13 MINUTES AFTER THE TREATMENT DEFIBRILLATION. IT WAS REPORTED THAT AFTER THE TREATMENT EVENT EMS RESPONDED AND INITIATED RESUSCITATION. ELECTRODE BELT (B)(4) IS NOT CURRENTLY AVAILABLE FOR INVESTIGATION AND WILL BE EVALUATED UPON ITS RETURN. DEVICE MANUFACTURE DATE: MONITOR (B)(4): 10/03/2012 - REUSE, ELECTRODE BELT (B)(4): 08/07/2013 - REUSE. SINCE WE CANNOT DEFINITIVELY CONFIRM THAT THE LIFEVEST DID NOT CONTRIBUTE TO THE PATIENT'S DEATH WE ARE REPORTING THIS EVENT OUT OF AN ABUNDANCE OF CAUTION. THERE IS NO EVIDENCE OR ALLEGATIONS THAT THE BELT COMMUNICATION ERRORS PRECLUDED THE DEVICE'S ABILITY TO DETECT AN ARRHYTHMIA AND DELIVER A TREATMENT DEFIBRILLATION.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY ON (B)(6) 2015. THE PATIENT EXPERIENCED A TREATMENT EVENT. THE PATIENT WAS AT HOME AND WAS UNCONSCIOUS AT THE TIME OF THE EVENT. IT WAS REPORTED THAT THE PATIENT'S LIFEVEST ALARMED AND THEN HE COLLAPSED. THE PATIENT'S SON WITNESSED THE EVENT. THE PATIENT RECEIVED ONE APPROPRIATE TREATMENT FOR VENTRICULAR FIBRILLATION (VF) AT 18:47:10. THE POST-SHOCK RHYTHM WAS AN IDIOVENTRICULAR RHYTHM AT 65 BEATS PER MINUTE. AT 18:47:42 A NON-TREATABLE RHYTHM WAS DETECTED. EMS RESPONDED AND BEGAN RESUSCITATION EFFORTS AND TRANSPORTED THE PATIENT TO THE HOSPITAL WHERE HE PASSED AWAY. IT WAS REPORTED THE PATIENT WAS NOT WEARING THE LIFEVEST AT THE TIME OF PASSING ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466685 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Death| H