BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 10909548 · Received November 26, 2020

    Report

    Report Number
    3008642652-2020-10602
    Event Type
    Death
    Date Received
    November 26, 2020
    Date of Event
    April 10, 2020
    Report Date
    November 25, 2020
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO DEATH OR DEVICE MALFUNCTION ASSOCIATED WITH THE INAPPROPRIATE DEFIBRILLATION EVENT. THE MONITOR SN (B)(4) AND ELECTRODE BELT SN (B)(4) HAVE NOT BEEN RETURNED TO THE DISTRIBUTOR FOR INVESTIGATION. DEVICE EVALUATION INCLUDES REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAY OF THE EVENT. THE REVIEW OF THE SOFTWARE FLAGS CONSISTED OF AN ANALYSIS OF THE DOWNLOADED DATA TO IDENTIFY ANY FAULT FLAGS OR UNUSUAL PATTERNS OF SOFTWARE FLAGS. THE SOFTWARE FLAG FILES DID NOT SUGGEST A DEVICE MALFUNCTION THAT WOULD CONTRIBUTE TO THE PATIENT TREATMENT. MONITOR - (B)(4) - 01/22/2015. ELECTRODE BELT - (B)(4) - 07/19/2016. THE INVESTIGATION INTO THE EVENT CONCLUDES THAT THERE WAS NO DEVICE MALFUNCTION. 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 (PATIENT ERROR). THE RESPONSE BUTTONS WERE PRESSED AFTER THE TREATMENT EVENT. THE RESPONSE BUTTONS FUNCTIONED APPROPRIATELY. THE ECG ANALYSIS, CONDUCTED BY TRAINED ECG TECHNICIANS, IDENTIFIED THE PRIMARY CAUSE OF THE FALSE DETECTION WAS SUPRAVENTRICULAR TACHYCARDIA (SVT). THE RAPID RATE SATISFIED THE RATE DETECTOR OF THE DETECTION ALGORITHM. 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 (B)(4) (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/P010030B.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 A FRENCH PATIENT PASSED AWAY ON 04/10/2020 IN A HOSPITAL WHILE REPORTEDLY WEARING THE LIFEVEST. REVIEW OF THE PATIENT'S DOWNLOAD DATA REVEALS THAT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT ON THE DATE OF THEIR PASSING CONSISTING OF ONE SHOCK. THE RESPONSE BUTTONS WERE PRESSED AFTER THE TREATMENT EVENT. THE RESPONSE BUTTONS FUNCTIONED APPROPRIATELY. SUPRAVENTRICULAR TACHYCARDIA (SVT) CONTRIBUTED TO THE FALSE DETECTION. THE RAPID RATE SATISFIED THE RATE DETECTOR OF THE DETECTION ALGORITHM. THE PATIENT SUBSEQUENTLY PASSED AWAY. THERE IS NO INDICATION THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE PATIENT'S PASSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1373097 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| O