BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 5979461 · Received September 27, 2016

    Report

    Report Number
    3008642652-2016-06926
    Event Type
    Death
    Date Received
    September 27, 2016
    Date of Event
    August 22, 2016
    Report Date
    September 26, 2016
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) HAVE NOT YET BEEN RETURNED FOR INVESTIGATION. A REVIEW OF DOWNLOAD DATA DOES NOT SUGGEST ANY DEVICE MALFUNCTION CAUSING OR CONTRIBUTING TO THE EVENT. A CAUSE AND EFFECT ANALYSIS WAS CONDUCTED USING ALL OF THE AVAILABLE INFORMATION WHICH INCLUDES THE INCIDENT REPORT, DEVICE EVALUATION, SOFTWARE FLAG FILES, AND ECG STRIPS. THE PRIMARY CAUSE OF THE INAPPROPRIATE SHOCK WAS IMPROPER RESPONSE BUTTON USE BY THE PATIENT DURING THE FALSE DETECTION, PRIOR TO SHOCK DELIVERY. THE ECG ANALYSIS, CONDUCTED BY TRAINED ECG TECHNICIANS, IDENTIFIED THE PRIMARY CAUSE OF THE FALSE DETECTION WAS THE PRESENCE OF NSVT. INAPPROPRIATE DEFIBRILLATIONS ARE AN ANTICIPATED RISK ASSOCIATED WITH THE USE OF THE LIFEVEST. PATIENTS ARE INSTRUCTED THROUGH ALARMS, VOICE MESSAGES, IFU, AND TRAINING TO PRESS THE RESPONSE BUTTONS TO PREVENT AN INAPPROPRIATE DEFIBRILLATION. THE CURRENT COMMERCIAL INAPPROPRIATE DEFIBRILLATION RATE IS CONSISTENT WITH THE OBSERVED RATE DURING THE PIVOTAL CLINICAL TRIAL G960083 (0.69% PER PATIENT-MONTH WITH 90% CONFIDENCE). A SUMMARY OF THE SAFETY AND EFFECTIVENESS DATA (SSED), INCLUDING THE INAPPROPRIATE DEFIBRILLATION SAFETY OBJECTIVE SUPPORTING FDA'S APPROVAL OF THE LIFEVEST, CAN BE FOUND AT <HTTP://WWW.ACCESSDATA.FDA.GOV/CDRH_DOCS/PDF/P010030S056B.PDF>. THE LIFEVEST DETECTION ALGORITHM COMPLIES WITH IEC 60601-2-4 PERFORMANCE REQUIREMENTS FOR SENSITIVITY AND SPECIFICITY.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT THE PATIENT PASSED AWAY ON (B)(6) 2016. A REVIEW OF DOWNLOAD DATA REVEALED THAT THE PATIENT WAS TREATED AT 06:50:29 ON (B)(6) 2016. THE RHYTHM AT THE TIME OF THE TREATMENT WAS AN INTERMITTENT IDIOVENTRICULAR RHYTHM WITH NSVT. THE PRESENCE OF NSVT CONTRIBUTED TO THE FALSE DETECTION. THE PATIENT REMAINED IN AN IDIOVENTRICULAR RHYTHM AFTER THE TREATMENT.. THE RESPONSE BUTTONS WERE PRESSED BEFORE THE TREATMENT, BUT NOT IN THE DETECTION SEQUENCE THAT LED TO THE SHOCK. THE LIFEVEST WAS SHUTDOWN AT 07:09:05. THE PATIENT REPORTEDLY PASSED AWAY AT 7:10AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632900 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Death