BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4734448 · Received April 24, 2015

    Report

    Report Number
    3008642652-2015-02400
    Event Type
    Injury
    Date Received
    April 24, 2015
    Date of Event
    May 4, 2014
    Report Date
    April 16, 2015
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    NVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO DEATH OR DEVICE MALFUNCTION ASSOCIATED WITH THE INAPPROPRIATE DEFIBRILLATION EVENT. 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. DEVICE MANUFACTURE DATE: ELECTRODE BELT: 04/2013. 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. (B)(6). 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

    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 (B)(6) YR OLD FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT A TREATMENT HAD BEEN DELIVERED WHILE SHE WAS EXERCISING. REVIEW OF THE EVENT INDICATES THAT THE PATIENT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION. MOTION ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. THE PATIENT REPORTEDLY WAS ATTEMPTING TO RESPOND TO THE ALARMS. REVIEW OF THE DOWNLOADED DATA INDICATES THAT THE RESPONSE BUTTONS WERE PRESSED AFTER THE TREATMENT WAS DELIVERED. THE PATIENT VISITED THE ER AND CONTINUED USE OF THE LIFEVEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272444 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR NVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| O