BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4955739 · Received July 31, 2015

    Report

    Report Number
    3008642652-2015-04722
    Event Type
    Injury
    Date Received
    July 31, 2015
    Date of Event
    July 2, 2015
    Report Date
    July 29, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO DEATH OR DEVICE MALFUNCTION ASSOCIATED WITH THE INAPPROPRIATE DEFIBRILLATION EVENT. DEVICE EVALUATION WAS ACCOMPLISHED THROUGH A REVIEW OF THE PATIENT'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): 06/03/2010 - REUSE; ELECTRODE BELT SN (B)(4): 03/23/2015 - INITIAL USE. 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 THE (B)(6) CLINICAL TRIAL (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 US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT. THE PATIENT WAS TREATED ONE TIME ON (B)(6) 2015 AT 09:58:32. THE PATIENT WAS CONSCIOUS AT THE TIME OF THE TREATMENT EVENT. MULTIPLE COUNTING OF T-WAVES AND OVER SENSING CARDIAC SIGNAL CONTRIBUTED TO THE FALSE DETECTION. A REVIEW OF THE DOWNLOADED DATA INDICATES THAT THE RESPONSE BUTTONS WERE PRESSED AFTER THE TREATMENT WAS DELIVERED. THE PATIENT WAS SEEN AT THE HOSPITAL, AND CONTINUED TO WEAR THE LIFEVEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500713 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| O