BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4251742 · Received November 5, 2014

    Report

    Report Number
    3008642652-2014-03631
    Event Type
    Injury
    Date Received
    November 5, 2014
    Date of Event
    October 26, 2014
    Report Date
    November 3, 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 THE PT WILL CONTINUE WEARING THE LIFEVEST. METHOD (OTHER): DEVICE EVAL 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. USAGE OF DEVICE: MONITOR(B)(4): 05/2013 - REUSE. ELECTRODE BELT (B)(4): 01/2014 - REUSE. ADDITIONAL INAPPROPRIATE DEFIBRILLATION NARRATIVE: 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. THE CURRENT COMMERCIAL INAPPROPRIATE DEFIBRILLATION RATE IS CONSISTENT WITH THE OBSERVED RATE DURING THE (B)(4)), INCLUDING THE INAPPROPRIATE DEFIBRILLATION SAFETY OBJECTIVE SUPPORTING FDA'S APPROVAL OF THE LIFEVEST, CAN BE FOUND AT (B)(4).

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT. MULTIPLE COUNTING CONTRIBUTED TO THE FALSE DETECTION. THE PT WAS "SEMI-CONSCIOUS" AT THE TIME OF THE EVENT. THE PT STATES THAT HE WAS HALF ASLEEP. A REVIEW OF THE DOWNLOADED DATA CONFIRMS THAT THE RESPONSE BUTTONS WERE NOT PRESSED THE ENTIRE EVENT. THE PT DID NOT SEEK MEDICAL ATTENTION. THE PT WILL CONTINUE WEARING THE LIFEVEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710350 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other