BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6329868 · Received February 14, 2017

    Report

    Report Number
    3008642652-2017-01321
    Event Type
    Death
    Date Received
    February 14, 2017
    Date of Event
    January 15, 2017
    Report Date
    February 14, 2017
    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

    DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) WAS COMPLETED. UPON INVESTIGATION THE ELECTRODE BELT ECG ACQUISITION AND PULSE DELIVERY CIRCUITRY WAS FULLY FUNCTIONAL. THERE WAS NO ELECTRODE BELT MALFUNCTION. DEVICE EVALUATION OF MONITOR SN (B)(4) IS CURRENTLY UNDERWAY. A REVIEW OF DOWNLOAD DATA DOES NOT SUGGEST ANY MONITOR MALFUNCTION CONTRIBUTING TO THE EVENT. 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, PRIOR TO SHOCK DELIVERY. THE ECG ANALYSIS, CONDUCTED BY TRAINED ECG TECHNICIANS, IDENTIFIED THE PRIMARY CAUSE OF THE FALSE DETECTION WAS A RAPID RATE ABOVE THE PRESCRIBED RATE THRESHOLD. 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 G960083 (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/P010030S056B.PDF>. THE LIFEVEST DETECTION ALGORITHM COMPLIES WITH IEC 60601-2-4 PERFORMANCE REQUIREMENTS FOR SENSITIVITY AND SPECIFICITY.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT THE PATIENT PASSED AWAY ON (B)(6) 2017 WHILE IN THE HOSPITAL. A REVIEW OF DOWNLOAD DATA REVEALED THAT THE PATIENT WAS TREATED TWICE ON (B)(6) 2017 AT 23:55:52 AND 23:56:23. RAPID SINUS TACHYCARDIA (160 BPM) CONTRIBUTED TO THE FALSE DETECTIONS. THE RESPONSE BUTTONS WERE NOT PRESSED UNTIL AFTER THE SECOND TREATMENT. THE PATIENT REMAINED IN SINUS TACHYCARDIA FOLLOWING THE TREATMENTS. AFTER THE TREATMENTS THE PATIENT WAS TRANSPORTED BY EMS TO THE HOSPITAL. THE LIFEVEST WAS REMOVED FROM THE PATIENT UPON ARRIVAL AT THE HOSPITAL. DEVICE DOWNLOAD DATA INDICATES THAT THE LIFEVEST WAS SHUT DOWN AT 00:48:50 ON (B)(6) 2017. THE PATIENT SUBSEQUENTLY PASSED AWAY WITHOUT WEARING THE LIFEVEST. THE EXACT TIME OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113122 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death