BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 10439809 · Received August 21, 2020

    Report

    Report Number
    3008642652-2020-07323
    Event Type
    Injury
    Date Received
    August 21, 2020
    Date of Event
    July 21, 2020
    Report Date
    August 21, 2020
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO DEATH OR DEVICE MALFUNCTION ASSOCIATED WITH THE INAPPROPRIATE DEFIBRILLATION EVENT. DEVICE EVALUATION SUMMARY: ELECTRODE BELT SN (B)(4) HAS BEEN RETURNED TO THE DISTRIBUTOR BUT HAS NOT BEEN EVALUATED YET. DEVICE EVALUATION INCLUDES REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAYS SURROUNDING THE EVENT. THE REVIEW OF THE SOFTWARE FLAGS CONSISTED OF AN ANALYSIS OF THE DOWNLOADED DATA TO IDENTIFY ANY FAULT FLAGS OR UNUSUAL PATTERNS OF SOFTWARE FLAGS. THE SOFTWARE FLAG FILES DID NOT SUGGEST A DEVICE MALFUNCTION THAT WOULD CONTRIBUTE TO THE PATIENT TREATMENT. MONITOR SN (B)(4) HAS BEEN NOT RETURNED TO THE DISTRIBUTOR FOR EVALUATION. DEVICE EVALUATION INCLUDES REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAYS SURROUNDING THE EVENT. THE REVIEW OF THE SOFTWARE FLAGS CONSISTED OF AN ANALYSIS OF THE DOWNLOADED DATA TO IDENTIFY ANY FAULT FLAGS OR UNUSUAL PATTERNS OF SOFTWARE FLAGS. THE SOFTWARE FLAG FILES DID NOT SUGGEST A DEVICE MALFUNCTION THAT WOULD CONTRIBUTE TO THE PATIENT TREATMENT. MANUFACTURE DATE: MONITOR - (B)(4) -02/27/2020, BELT - (B)(4) -03/002/2015. THE INVESTIGATION INTO THE EVENT CONCLUDES THAT THERE WAS NO DEVICE MALFUNCTION. A CAUSE AND EFFECT ANALYSIS WAS CONDUCTED USING ALL OF THE AVAILABLE INFORMATION WHICH INCLUDES THE INCIDENT REPORT, DEVICE EVALUATION, SOFTWARE FLAG FILES, AND ECG STRIPS . THE PRIMARY CAUSE OF THE INAPPROPRIATE SHOCK WAS IMPROPER RESPONSE BUTTON USE BY THE PATIENT DURING THE FALSE DETECTION. RESPONSE BUTTONS WERE PRESSED DURING THE EVENT BUT NOT IMMEDIATELY PRIOR TO THE DELIVERY OF THE SHOCKS. THE RESPONSE BUTTONS FUNCTIONED APPROPRIATELY. THE ECG ANALYSIS, CONDUCTED BY TRAINED ECG TECHNICIANS, IDENTIFIED THE PRIMARY CAUSE OF THE FALSE DETECTION WAS MOTION ARTIFACT AND SUPRAVENTRICULAR TACHYCARDIA (SVT). THE RAPID RATE SATISFIED THE RATE DETECTOR OF THE DETECTION ALGORITHM. THE SOURCE OF THE ARTIFACT COULD NOT BE POSITIVELY IDENTIFIED THROUGH CAUSE AND EFFECT ANALYSIS. THE FOLLOWING COULD NOT BE RULED OUT AS CONTRIBUTING FACTORS: BODY MOTION, POOR ECG CONTACT WITH SKIN. 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. INAPPROPRIATE TREATMENT EVENTS ARE ASSESSED DURING THE MONTHLY DATA ANALYSIS OF COMPLAINTS PER (B)(4).

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT CONSISTING OF ELEVEN SHOCKS. IT WAS REPORTED THAT THE PATIENT WAS IN A HOSPITAL WHEN TREATED BY THE LIFEVEST. RESPONSE BUTTONS WERE PRESSED DURING THE EVENT BUT NOT IMMEDIATELY PRIOR TO THE DELIVERY OF THE SHOCKS. THE RESPONSE BUTTONS FUNCTIONED APPROPRIATELY. SUPRAVENTRICULAR TACHYCARDIA (SVT) AND MOTION ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. THE RAPID RATE SATISFIED THE RATE DETECTOR OF THE DETECTION ALGORITHM. THE PATIENT RECEIVED CONTINUED MEDICAL ATTENTION AT A HOSPITAL AND CONTINUES TO WEAR THE LIFEVEST. THERE WAS NO DEATH OR DEVICE MALFUNCTION ASSOCIATED WITH THE INAPPROPRIATE DEFIBRILLATION EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904692 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other