BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 24897408 · Received April 16, 2026

    Report

    Report Number
    3008642652-2026-03683
    Event Type
    Injury
    Date Received
    April 16, 2026
    Date of Event
    April 7, 2026
    Report Date
    April 16, 2026
    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 · 0

    THE MONITOR AND ELECTRODE BELT HAVE NOT BEEN RETURNED FOR EVALUATION. BASED ON THE DATA AVAILABLE AT THIS TIME, THERE IS NO INDICATION OF A DEVICE MALFUNCTION CAUSING OR CONTRIBUTING TO THE INAPPROPRIATE TREATMENT. 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.

    Description of Event or Problem · 0

    A PATIENT RECEIVED TWO INAPPROPRIATE SHOCKS. AF WITH RVR CONTRIBUTED TO THE FALSE DETECTION. THE RB¿S WERE NOT PRESSED DURING THE EVENT. THE PATIENT CONTINUES WEARING LIFEVEST. NO INJURY WAS REPORTED FROM THE TREATMENT. NO DEFICIENCIES WERE ALLEGED AGAINST THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963517 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown