BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 5151451 · Received October 15, 2015

    Report

    Report Number
    3008642652-2015-06288
    Event Type
    Injury
    Date Received
    October 15, 2015
    Date of Event
    September 23, 2015
    Report Date
    October 9, 2015
    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

    THERE WAS NO DEATH OR DEVICE MALFUNCTION ASSOCIATED WITH THE INAPPROPRIATE DEFIBRILLATION EVENTS. THERE IS NO INDICATION THAT THE PATIENT SUSTAINED A SERIOUS INJURY. DEVICE EVALUATION SUMMARY: ELECTRODE BELT SN (B)(4) HAS NOT BEEN RECOVERED FROM THE FIELD. DOWNLOAD DATA DOES NOT INDICATE ANY ELECTRODE BELT MALFUNCTION. THE MONITOR SN (B)(4) WAS RETURNED AND EVALUATED AT THE DISTRIBUTOR, IN ACCORDANCE WITH PROCEDURES RECOMMENDED BY ZOLL MANUFACTURING CORPORATION. THE EVALUATION INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES 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 INAPPROPRIATE TREATMENT. DURING THE INCOMING FUNCTIONAL TESTING, A 1HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE MONITOR, 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 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. LATER DURING THE EVALUATION OF MONITOR SN (B)(4), THE MONITOR RESET DURING A PULSE TEST. THE ROOT CAUSE FOR THE RESET WAS NOISE FROM THE DEFIBRILLATOR PCA HIGH-VOLTAGE CAPACITORS PROPAGATING ON THE MAIN BATTERY WIRE ON THE MONITOR C/A BOARD. PMA SUPPLEMENT P010030/S064 WAS SUBMITTED TO FDA FOR A DESIGN CHANGE TO ADDRESS THIS ISSUE AND DEEMED APPROVABLE. THERE IS NO INDICATION THAT THE RESET DURING PULSE TESTING CONTRIBUTED TO THE TREATMENT EVENT. 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 EVENT WAS LACK OF RESPONSE BUTTON USE PRIOR TO SHOCK DELIVERY. THE ECG ANALYSIS, CONDUCTED BY TRAINED ECG TECHNICIANS, IDENTIFIED THE PRIMARY CAUSE OF THE FALSE DETECTION WAS MOTION ARTIFACT. THE SOURCE OF THE MOTION 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 MOTION ARTIFACT: 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). 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 (PDF). THE LIFEVEST DETECTION ALGORITHM COMPLIES WITH (B)(4) PERFORMANCE REQUIREMENTS FOR SENSITIVITY AND SPECIFICITY.

    Description of Event or Problem · 1

    US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT EXPERIENCED AN INAPPROPRIATE TREATMENT EVENT. MOTION ARTIFACT CONTRIBUTED TO THE FALSE DETECTION. IT IS UNKNOWN WHETHER THE PATIENT WAS CONSCIOUS. THE RESPONSE BUTTONS WERE NOT USED PRIOR TO THE TREATMENT. THERE IS NO INDICATION THAT THE PATIENT SOUGHT MEDICAL ATTENTION. THE PATIENT CONTINUED TO WEAR THE LIFEVEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682758 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other