BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4883660 · Received June 29, 2015

    Report

    Report Number
    3008642652-2015-04128
    Event Type
    Injury
    Date Received
    June 29, 2015
    Date of Event
    March 28, 2015
    Report Date
    June 26, 2015
    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. THE PT RECEIVED AN ICD ON (B)(4) 2015. THERE IS NO INFO TO SUGGEST THAT THE PT SUSTAINED A SERIOUS INJURY. (OTHER): 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. DEVICE MANUFACTURE DATE: MONITOR SN (B)(4) 01/2015 - INITIAL. ELECTRODE BELT SN (B)(4) : 01/01/2015 - INITIAL. 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 (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. AFTER REVIEW OF THE DOWNLOADED DATA, IT WAS CONFIRMED THAT THE PT RECEIVED ONE INAPPROPRIATE TREATMENT AT 21:14:33 ON (B)(6) 2015. MOTION ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. A REVIEW OF THE DOWNLOADED DATA CONFIRMS THAT THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE ENTIRE EVENT. THE PT RECEIVED AN ICD ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417418 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other