BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4733923 · Received April 23, 2015

    Report

    Report Number
    3008642652-2015-02358
    Event Type
    Injury
    Date Received
    April 23, 2015
    Date of Event
    March 24, 2014
    Report Date
    April 16, 2015
    Manufacturer
    ZOLL MANUFACTURING CORP
    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 EVENT. DEVICE EVALUATION OF MONITOR SN (B)(4) AND BELT SN (B)(4) WAS COMPLETED. THE MONITOR AND ELECTRODE BELT WERE FUNCTIONAL AND ABLE TO DETECT AND TREAT. MONITOR: 12/01/2013 - INITIAL USE, ELECTRODE BELT: 12/01/2013 - INITIAL USE. INAPPROPRIATE DEFIBRILLATIONS ARE AN ANTICIPATED RISK ASSOCIATED WITH THE USE OF THE LIFEVEST. PTS 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. ZOLL CUSTOMER SUPPORT WAS NOTIFIED VIA DOWNLOAD DATA THAT A (B)(6) YEAR OLD MALE PT WAS TREATED WHILE AT HOME. THE LIFEVEST DELIVERED AN INAPPROPRIATE TREATMENT AT 10:37:00 DURING ATRIAL FIBRILLATION WITH A RAPID VENTRICULAR RESPONSE (156 BPM). THE RAPID ATRIAL FIBRILLATION AND MOTION ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. THE RESPONSE BUTTONS WERE NOT USED DURING THE EVENT. THE PT WENT TO THE HOSPITAL FOR FURTHER EVALUATION AND CONTINUED TO USE THE LIFEVEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269727 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| O