BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 5730239 · Received June 16, 2016

    Report

    Report Number
    3008642652-2016-04066
    Event Type
    Death
    Date Received
    June 16, 2016
    Date of Event
    May 13, 2016
    Report Date
    June 16, 2016
    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 SUMMARY: MONITOR SN 0(B)(4) WAS RETURNED AND EVALUATED AT THE DISTRIBUTOR IN ACCORDANCE WITH PROCEDURES RECOMMENDED BY ZOLL MANUFACTURING INFORMATION. BELT SN (B)(4) WAS RETURNED AND EVALUATED AT ZOLL MANUFACTURING CORPORATION. THE EVALUATION INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES (ATTACHED) ON THE DAY OF THE EVENT AND INCOMING FUNCTIONAL TESTING. 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 EVENT. DURING THE INCOMING FUNCTIONAL TESTING, A 1HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE ECG ELECTRODES, FOLLOWED BY A 5HZ SIMULATED TREATABLE ARRHYTHMIA SIGNAL WHICH VERIFIED PROPER PERFORMANCE OF THE DETECTION ALGORITHM. DURING THE TRANSITION TO THE 5HZ SIGNAL, THE DEVICE WAS CONFIRMED TO PROPERLY ENTER INTO A TREATMENT SEQUENCE WHICH INCLUDES A VERIFICATION OF THE TACTILE VIBRATION ALARM, AUDIO MESSAGING, AND SIREN ALARMS, AS WELL AS A TEST OF THE PULSE DELIVERY CIRCUITRY. THE PULSE DELIVERY CIRCUITRY TEST VERIFIED PROPER CHARGING OF THE HIGH VOLTAGE CAPACITORS AND PROPER DELIVERY OF FIVE FULL ENERGY 150J BIPHASIC PULSES. THE FUNCTIONAL TESTING CONFIRMED PROPER RESPONSE BUTTON FUNCTIONALITY, ECG ACQUISITION, DETECTION ALGORITHM PERFORMANCE, AND PULSE DELIVERY FUNCTIONALITY. DEVICE MANUFACTURE DATE: MONITOR: 03/31/2015. ELECTRODE BELT: 01/25/2012. ADDITIONAL INAPPROPRIATE DEFIBRILLATION NARRATIVE: THE INVESTIGATION INTO THE EVENT CONCLUDES THAT THERE WAS NO DEVICE MALFUNCTION. A CAUSE AND EFFECT ANALYSIS WAS CONDUCTED (ATTACHED) USING ALL OF THE AVAILABLE INFORMATION WHICH INCLUDES THE INCIDENT REPORT, DEVICE EVALUATION, SOFTWARE FLAG FILES, AND ECG STRIPS (ATTACHED). THE PRIMARY CAUSE OF BOTH INAPPROPRIATE SHOCK EVENTS 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 DETECTIONS WAS ECG MOTION ARTIFACT. THE SOURCE OF THE ARTIFACT COULD NOT BE POSITIVELY IDENTIFIED THROUGH THE CAUSE AND EFFECT ANALYSIS. THE FOLLOWING FACTORS COULD NOT BE RULED OUT AS CONTRIBUTING CAUSES OF THE ARTIFACT: BODY MOTION. POOR ECG CONTACT WITH SKIN. THERE IS NO CAPA INITIATED AT THIS TIME. 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 (B)(6) TRIAL (B)(6) ((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. THE LIFEVEST DETECTION ALGORITHM COMPLIES WITH (B)(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 LIFEVEST PATIENT PASSED AWAY ON (B)(6) 2016. REVIEW OF THE EVENTS SURROUNDING THE PATIENT'S DEATH INDICATE THAT THE PATIENT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT ON (B)(6) 2016 AT 00:19:45. THE RHYTHM AT THE TIME OF THE SHOCK WAS SINUS TACHYCARDIA AT 135BPM. THE RESPONSE BUTTONS WERE PRESSED AFTER THE EVENT. ASYSTOLE WAS LATER DETECTED ON (B)(6) 2016 AT 2:44:02. THERE IS NO EVIDENCE TO SUGGEST THAT THE LIFEVEST CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH AS ASYSTOLE IS CONSIDERED A NON-LIFE SUSTAINING RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383306 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death