BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYS

    MDR report key: 4173276 · Received September 23, 2014

    Report

    Report Number
    3008642652-2014-02743
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 18, 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 REMAINED AT HOME FOLLOWING THE TREATMENT AND CONTINUES TO WEAR 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)- 11/2012 (REUSE); ELECTRODE BELT (B)(4)- 02/2012 (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 (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

    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 REPORTED TO BE REMOVING THE LIFEVEST AT THE TIME OF TREATMENT. SHE WAS CHANGING HER GARMENT AND DID NOT REMOVE THE BATTERY. THE PT REPORTED THAT SHE WAS NOT WEARING THE DEVICE AND DID NOT FEEL THE SHOCK. THE PT WAS AT HOME AT THE TIME OF THE EVENT. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE ENTIRE EVENT. THE PT REMAINED AT HOME AND CONTINUES TO WEAR THE LIFEVEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591146 LIFEVEST WCD 4000 SYS WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other