BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 6092235 · Received November 10, 2016

    Report

    Report Number
    3008642652-2016-08217
    Event Type
    Injury
    Date Received
    November 10, 2016
    Date of Event
    October 8, 2016
    Report Date
    December 15, 2016
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: ELECTRODE BELT (B)(4) EVALUATION: DEVICE EVALUATION OF ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. 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 INAPPROPRIATE TREATMENT. 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 AS WELL AS A TEST OF THE PULSE DELIVERY CIRCUITRY. THE PULSE DELIVERY CIRCUITRY TEST VERIFIED PROPER DELIVERY OF FIVE FULL ENERGY 150J BIPHASIC PULSES. THE FUNCTIONAL TESTING CONFIRMED PROPER ECG ACQUISITION, DETECTION ALGORITHM PERFORMANCE, AND PULSE DELIVERY FUNCTIONALITY. MONITOR (B)(4) EVALUATION: DEVICE EVALUATION OF MONITOR (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (PATIENT TREATMENT) WAS CONFIRMED. DURING THE TREATMENT EVENT, THE MONITOR EXPERIENCED A PULSE RESET AFTER THE SECOND SHOCK. THE ROOT CAUSE FOR THE RESETS WAS ISOLATED TO NOISE ORIGINATING FROM THE DEFIBRILLATOR PCA HIGH-VOLTAGE CAPACITORS AND PROPAGATING ON THE MAIN BATTERY WIRE ON THE MONITOR C/A BOARD. A DESIGN CHANGE TO ADDRESS THIS CONDITION (PMA SUPPLEMENT P010030/S064) WAS APPROVED BY FDA ON (B)(6) 2015. THERE IS NO INDICATION THAT THE MONITOR RESETS CAUSED OR CONTRIBUTED TO THE INAPPROPRIATE TREATMENT. DEVICE MANUFACTURE DATE: MONITOR (B)(4): (B)(6) 2015 REUSE. ELECTRODE BELT (B)(4): (B)(6) 2015 REUSE. ADDITIONAL INAPPROPRIATE DEFIBRILLATION NARRATIVE ROOT CAUSE: 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 (PATIENT PRESSED THE RESPONSE BUTTONS EARLIER IN THE DETECTION SEQUENCE AND NOT IMMEDIATELY PRIOR TO SHOCK DELIVERY). THE ECG ANALYSIS, CONDUCTED BY TRAINED ECG TECHNICIANS, IDENTIFIED THE PRIMARY CAUSE OF THE FALSE DETECTION WAS MULTIPLE COUNTING OF T-WAVES. 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.

    Additional Manufacturer Narrative · 1

    CORRECTION TO MONITOR SN (B)(4) EVALUATION: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON FURTHER REVIEW OF THE FLAGS, A PULSE RESET DID NOT OCCUR. THE ABNORMAL SHUTDOWN OCCURRED AFTER THE SECOND PULSE WAS DELIVERED DUE TO AN INTERRUPTION IN BELT COMMUNICATION. THE MONITOR WAS FULLY FUNCTIONAL, INDICATING THE INTERRUPTION IN BELT COMMUNICATION WAS NOT DUE TO A DEVICE MALFUNCTION. AS RECEIVED, THE MONITOR PASSED INCOMING FUNCTIONAL TESTING. DURING THE INCOMING FUNCTIONAL TESTING, A 1HZ SIMULATED NORMAL SINUS RHYTHM SIGNAL WAS APPLIED TO THE DEVICE, 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. THERE IS NO INDICATION THAT THE ABNORMAL SHUTDOWN CAUSED OR CONTRIBUTED TO THE INAPPROPRIATE TREATMENT. DEVICE EVALUATION SUMMARY: ELECTRODE BELT SN (B)(4) EVALUATION: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. 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 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 AS WELL AS A TEST OF THE PULSE DELIVERY CIRCUITRY. THE PULSE DELIVERY CIRCUITRY TEST VERIFIED PROPER DELIVERY OF FIVE FULL ENERGY 150J BIPHASIC PULSES. THE FUNCTIONAL TESTING CONFIRMED PROPER ECG ACQUISITION, DETECTION ALGORITHM PERFORMANCE, AND PULSE DELIVERY FUNCTIONALITY. DEVICE MANUFACTURE DATE: MONITOR SN (B)(4): 01/09/2015 REUSE; ELECTRODE BELT SN (B)(4): 06/08/2015 REUSE. ROOT CAUSE: 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 (PATIENT PRESSED THE RESPONSE BUTTONS EARLIER IN THE DETECTION SEQUENCE AND NOT IMMEDIATELY PRIOR TO SHOCK DELIVERY). THE ECG ANALYSIS, CONDUCTED BY TRAINED ECG TECHNICIANS, IDENTIFIED THE PRIMARY CAUSE OF THE FALSE DETECTION WAS MULTIPLE COUNTING OF T-WAVES. 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. (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 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 THREE SHOCKS. THE PATIENT WAS AT HOME AND SLEEPING AT THE TIME OF THE EVENT. THE RHYTHM AT THE TIME OF ALL THREE SHOCKS WAS SINUS TACHYCARDIA. THE POST-SHOCK RHYTHM OF THE FIRST AND THIRD SHOCKS WAS SINUS TACHYCARDIA. THE ECG IS NOT AVAILABLE FOR THE POST-SHOCK RHYTHM OF THE SECOND SHOCK DUE TO AN ABNORMAL DEVICE SHUTDOWN. FLAG FILES THAT OCCURRED DURING THE TIME OF THE SECOND TREATMENT ARE CONSISTENT WITH A PULSE RESET. MULTIPLE COUNTING OF T-WAVES CONTRIBUTED TO THE FALSE DETECTION. THE RESPONSE BUTTONS WERE PRESSED EARLIER IN THE DETECTION SEQUENCE BEFORE THE FIRST SHOCK, BUT NOT IMMEDIATELY PRIOR TO TREATMENT DELIVERY. THE RESPONSE BUTTONS FUNCTIONED APPROPRIATELY. NO DEATH OR SERIOUS INJURY RESULTED FROM THE EVENT. THERE IS NO INFORMATION TO SUGGEST THAT THE ABNORMAL SHUTDOWN CAUSED OR CONTRIBUTED TO THE EVENT. THE PATIENT DID NOT SEEK MEDICAL INTERVENTION AND CONTINUED TO WEAR THE LIFEVEST.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT CONSISTING OF THREE SHOCKS. THE PATIENT WAS AT HOME AND SLEEPING AT THE TIME OF THE EVENT. THE RHYTHM AT THE TIME OF ALL THREE SHOCKS WAS SINUS TACHYCARDIA. THE POST-SHOCK RHYTHM OF THE FIRST AND THIRD SHOCKS WAS SINUS TACHYCARDIA. THE ECG IS NOT AVAILABLE FOR THE POST-SHOCK RHYTHM OF THE SECOND SHOCK DUE TO AN ABNORMAL DEVICE SHUTDOWN DUE TO AN INTERRUPTION IN BELT COMMUNICATION. MULTIPLE COUNTING OF T-WAVES CONTRIBUTED TO THE FALSE DETECTION. THE RESPONSE BUTTONS WERE PRESSED EARLIER IN THE DETECTION SEQUENCE BEFORE THE FIRST SHOCK, BUT NOT IMMEDIATELY PRIOR TO TREATMENT DELIVERY. THE RESPONSE BUTTONS FUNCTIONED APPROPRIATELY. NO DEATH OR SERIOUS INJURY RESULTED FROM THE EVENT. THERE IS NO INFORMATION TO SUGGEST THAT THE ABNORMAL SHUTDOWN CAUSED OR CONTRIBUTED TO THE EVENT. THE PATIENT DID NOT SEEK MEDICAL INTERVENTION AND CONTINUED TO WEAR THE LIFEVEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746051 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR