BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4734163 · Received April 24, 2015

    Report

    Report Number
    3008642652-2015-02131
    Event Type
    Death
    Date Received
    April 24, 2015
    Date of Event
    March 6, 2014
    Report Date
    April 13, 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 MONITOR SN (B)(4) AND BELT SN (B)(4) WAS COMPLETED. THE MONITOR AND ELECTRODE BELT WERE FULLY FUNCTIONAL AND ABLE TO DETECT AND TREAT. USAGE: MONITOR: 12/01/2012. ELECTRODE BELT: 11/01/2013.

    Description of Event or Problem · 1

    DURING A RETROACTIVE REVIEW OF PAST TREATMENT EVENTS FOR POTENTIAL ADVERSE EVENTS, CONDUCTED AS A CAPA IN RESPONSE TO A RECENT FDA INSPECTION, A REPORTABLE ADVERSE EVENT WAS DISCOVERED. A ZOLL REPRESENTATIVE CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT A (B)(6) MALE PT PASSED AWAY. REVIEW OF THE EVENTS SURROUNDING THE PT'S DEATH INDICATES THAT THE PT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT CONSISTING OF TWO SHOCKS. OVERSENSING OF SMALL SIGNAL DURING ASYSTOLE CONTRIBUTED TO THE FALSE DETECTIONS. THE PT WAS REPORTEDLY UNCONSCIOUS AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274194 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death