BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 4792570 · Received May 20, 2015

    Report

    Report Number
    3008642652-2015-03295
    Event Type
    Injury
    Date Received
    May 20, 2015
    Date of Event
    April 16, 2015
    Report Date
    May 15, 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. THERE IS NO INFO TO SUGGEST THE PT SUSTAINED A SERIOUS INJURY. EVAL: 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. MFG DATE AND USAGE OF DEVICE: MONITOR (B)(4): 12/2010-REUSE; ELECTRODE BELT (B)(4): 07/2014-REUSE. ADD'L 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. (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 DIST CONTACTED ZOLL ON (B)(6) 2015 TO REPORT THAT A PT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT. RAPID ATRIAL FIBRILLATION WITH A RAPID VENTRICULAR RESPONSE AND MOTION ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. THE PT WAS REPORTED TO BE CONSCIOUS BUT HAD DEMENTIA AND WAS NOT ABLE TO PRESS THE RESPONSE BUTTONS. A REVIEW OF THE EVENT CONFIRMS THAT THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE ENTIRE EVENT. THE PT CONTINUED USE OF THE LIFEVEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327663 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other