BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4476091 · Received January 29, 2015

    Report

    Report Number
    3008642652-2015-00416
    Event Type
    Injury
    Date Received
    January 29, 2015
    Date of Event
    January 18, 2015
    Report Date
    January 23, 2015
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    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

    THERE WAS NO DEATH OR DEVICE MALFUNCTION ASSOCIATED WITH THE INAPPROPRIATE DEFIBRILLATION. THE PATIENT WAS TAKEN TO THE HOSPITAL AND WILL CONTINUE TO WEAR THE LIFEVEST. DEVICE EVALUATION WAS ACCOMPLISHED THROUGH A REVIEW OF THE PATIENT'S DOWNLOADED DATA FILE. REVIEW OF THE DATA DOES NOT INDICATE ANY DEVICE MALFUNCTION RELATED TO THE DEFIBRILLATION EVENT. DEVICE MANUFACTURE DATE & USAGE OF DEVICE: MONITOR (B)(4): 02/02013 - REUSE. ELECTRODE BELT (B)(4): 05/2014 - REUSE. ADDITIONAL INAPPROPRIATE DEFIBRILLATION NARRATIVE: 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). 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 · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT. SINUS TACHYCARDIA AT 120BPM WITH MOTION ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. THE PATIENT WAS ALONE AT HOME IN BED AT THE TIME OF THE EVENT. IT WAS REPORTED THAT THE PATIENT DOES NOT REMEMBER THE EVENT. A REVIEW OF THE DOWNLOADED DATA CONFIRMS THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE ENTIRE EVENT. THE PATIENT WAS TAKEN TO THE HOSPITAL AND WILL CONTINUE TO WEAR THE LIFEVEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68370 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| O