BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 19163830 · Received April 23, 2024

    Report

    Report Number
    3008642652-2024-04208
    Event Type
    Injury
    Date Received
    April 23, 2024
    Date of Event
    March 26, 2024
    Report Date
    April 23, 2024
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE DATA AVAILABLE AT THIS TIME, THERE IS NO INDICATION OF A DEVICE MALFUNCTION CAUSING OR CONTRIBUTING TO THE INAPPROPRIATE TREATMENT. 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 PIVOTAL CLINICAL TRIAL (B)(4) (0.69% PER PATIENT-MONTH WITH 90% CONFIDENCE). 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. THE LIFEVEST DETECTION ALGORITHM COMPLIES WITH IEC 60601-2-4 PERFORMANCE REQUIREMENTS FOR SENSITIVITY AND SPECIFICITY.

    Description of Event or Problem · 0

    US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT WAS TREATED AT HOME. THE PATIENT WAS REPORTEDLY CONSCIOUS AT THE TIME OF THE EVENT.. NO INJURY WAS REPORTED FROM THE TREATMENT. THE PATIENT WENT TO THE HOSPITAL FOR EVALUATION. IT IS UNKNOWN IF THE PATIENT CONTINUED TO USE THE LIFEVEST. NO DEFICIENCIES WERE ALLEGED AGAINST THE DEVICE. PER FLAG FILE REVIEW THE PATIENT RECEIVED ONE LIFEVEST TREATMENTS ON (B)(6) 2024, SEE CLINICAL ANALYSIS BELOW. PER CLINICAL AFFAIRS WHEN REVIEWING HOLTER: SVT, MOTION ARTIFACT, AND ELECTRODE LEAD FALLOFF CONTRIBUTED TO THE TREATMENT DETECTION AT 20:03:50 PM. THE RESPONSE BUTTONS WERE PRESSED EARLIER IN THE DETECTION SEQUENCE BUT NOT IMMEDIATELY PRIOR TO SHOCK DELIVERY. THE RESPONSE BUTTONS FUNCTIONED APPROPRIATELY. DUE TO AN SD CARD FAULT AND DL CODE 176 ERRORS, THE RECORDING AT 20:05:40 PM WAS UNABLE TO BE CAPTURED. THE DEVICE WAS THEN SHUTDOWN AT 20:05:47 AND RESTARTED AT 21:39:29 AFTER REPORTED TREATMENTS. NO TREATMENTS WERE THEN VISIBLE ON 3/26/2024, AND EVENT ANALYSIS CANNOT BE PROVIDED. THE ECG RECORDINGS ARE NOT AVAILABLE FOR REVIEW ON THE DAY OF THE DEFIBRILLATIONS DUE TO SD CARD FAULT. FLAG FILES ARE ATTACHED SHOWING PULSE DELIVERED FLAGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946850 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization