BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYS

    MDR report key: 4173251 · Received September 23, 2014

    Report

    Report Number
    3008642652-2014-02963
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    September 14, 2014
    Report Date
    September 19, 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. THE PT IS IN THE HOSPITAL. THE PT'S PHYSICIAN ENDED THE PT'S USE OF THE DEVICE. 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): (B)(6) 2014 - INITIAL USE; ELECTRODE BELT (B)(4): (B)(6) 2014 - 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 ANY INAPPROPRIATE DEFIBRILLATION. THE CURRENT COMMERCIAL INAPPROPRIATE DEFIBRILLATION RATE IS CONSISTENT WITH THE OBSERVED RATE DURING THE PIVOTAL 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 UNITED STATES DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PT EXPERIENCED FOUR INAPPROPRIATE DEFIBRILLATION TREATMENTS. ATRIAL FLUTTER AT 152BPM AND 155BPM CONTRIBUTED TO THE FIRST TWO FALSE DETECTIONS. ATRIAL FLUTTER AT 150BPM WITH MOTION ARTIFACT CONTRIBUTED TO THE THIRD AND FOURTH FALSE DETECTIONS. THE PT IS IN THE HOSPITAL. THE PT WAS UNCONSCIOUS AND A VENTILATOR AT THE TIME OF THE TREATMENTS. THE THIRD AND FOURTH PULSES THAT WERE DELIVERED TO THE PT WERE 7 JOULES OF ENERGY. THE LOW ENERGY SHOCKS WERE LIKELY DUE TO THE PULSE BEING DELIVERED INTO AN OPEN LOAD. IT IS LIKELY THAT THE THERAPY PADS ON THE LIFEVEST WERE NOT MAKING FULL CONTACT WITH THE PT. A REVIEW OF THE DOWNLOADED DATA CONFIRMS THE RESPONSE BUTTONS WERE PRESSED INTERMITTENTLY BUT THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE TREATMENT SEQUENCE THAT RESULTED IN THE INAPPROPRIATE DEFIBRILLATION TREATMENTS. THE PT'S PHYSICIAN ENDED THE PT'S USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590986 LIFEVEST WCD 4000 SYS WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| O