BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYS

    MDR report key: 4173255 · Received September 23, 2014

    Report

    Report Number
    3008642652-2014-02970
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    September 16, 2014
    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. THERE IS NO INFO TO SUGGEST THAT THE PT SUSTAINED A SERIOUS INJURY. THE PT DID NOT SEEK MEDICAL ATTENTION AND REMAINED AT HOME. THE PT WILL CONTINUE WEARING THE LIFEVEST. DEVICE EVALUATION WAS ACCOMPLISHED THROUGH A REVIEW OF THE PT'S DOWNLOADED DATA FILE. REVIEW OF THE DATA DOES NOT INDICATE ANY DEVICE MALFUNCTION RELATED TO THE DEFIBRILLATION EVENT. MONITOR (B)(4): 01/2013 - REUSE, ELECTRODE BELT (B)(4): 06/2011 - 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 ANY INAPPROPRIATE DEFIBRILLATION. THE CURRENT COMMERCIAL INAPPROPRIATE DEFIBRILLATION RATE IS CONSISTENT WITH THE OBSERVED RATE DURING THE (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 UNITED STATES DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT. MOTION ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. THE PT WAS CONSCIOUS AT THE TIME OF THE EVENT. IT WAS REPORTED THAT THE PT PRESSED THE RESPONSE BUTTONS. A REVIEW OF THE DOWNLOADED DATA CONFIRMS THE PT PRESSED THE RESPONSE BUTTONS AFTER THE TREATMENT WAS DELIVERED, BUT THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE TREATMENT SEQUENCE THAT RESULTED IN THE INAPPROPRIATE DEFIBRILLATION TREATMENTS. THE PT DID NOT SEEK MEDICAL ATTENTION, BUT REMAINED AT HOME. THE PT WILL CONTINUE WEARING THE LIFEVEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591114 LIFEVEST WCD 4000 SYS WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other