BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 5067650 · Received September 10, 2015

    Report

    Report Number
    3008642652-2015-05530
    Event Type
    Death
    Date Received
    September 10, 2015
    Date of Event
    August 9, 2015
    Report Date
    November 18, 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 INFORMATION TO SUGGEST THAT THE PATIENT SUSTAINED A SERIOUS INJURY. DEVICE EVALUATION SUMMARY: THE MONITOR SN (B)(4) AND BELT SN (B)(4) WERE 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 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: 08/23/2013. ELECTRODE BELT: 02/21/2014. 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 EVENTS WAS LACK OF 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 AN ELEVATED HEART RATE EXCEEDING THE PROGRAMMED 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 (PDF). THE LIFEVEST DETECTION ALGORITHM COMPLIES WITH IEC 60601-2-4 PERFORMANCE REQUIREMENTS FOR SENSITIVITY AND SPECIFICITY.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT - CORRECTION - 11/18/2015. DEVICE EVALUATION SUMMARY: THE PATIENT RECEIVED REPLACEMENT EQUIPMENT (MONITOR SN (B)(4) AND BELT SN (B)(4)) FROM THE DISTRIBUTOR AFTER THE TREATMENT EVENT THE MORNING OF (B)(6) 2015. THE MONITOR SN (B)(4) AND BELT SN (B)(4) WERE 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 PATIENT DEATH. 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 SN (B)(4): 08/23/2013, ELECTRODE BELT SN (B)(4): 02/21/2014. MONITOR SN (B)(4): 02/09/2015. ELECTRODE BELT SN (B)(4): 01/26/2012. THE MONITOR SN (B)(4) AND BELT SN (B)(4) WERE RETURNED AND EVALUATED AT THE DISTRIBUTOR, IN ACCORDANCE WITH PROCEDURES RECOMMENDED BY 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 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, 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: 08/23/2013, ELECTRODE BELT: 02/21/2014. 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 EVENTS WAS LACK OF 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 AN ELEVATED HEART RATE EXCEEDING THE PROGRAMMED 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 (B)(6) (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 (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 A PATIENT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT WHILE IN A SKILLED NURSING FACILITY. AN ELEVATED HEART RATE CONTRIBUTED TO THE FALSE DETECTION. THE PATIENT WAS REPORTEDLY CONSCIOUS AT THE TIME OF THE EVENT. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE EVENT. THERE IS NO INFORMATION TO SUGGEST THAT THE PATIENT SOUGHT MEDICAL ATTENTION. THE PATIENT CONTINUED USE OF THE LIFEVEST.

    Description of Event or Problem · 1

    FOLLOW-UP REPORT - ADDITIONAL INFORMATION -11/18/2015: ON (B)(6) 2015 A US DISTRIBUTOR NOTIFIED ZOLL THAT THIS PATIENT PASSED AWAY THE EVENING OF (B)(6) 2015. THE PATIENT WAS WITH HIS DAUGHTER IN A NURSING HOME AT THE TIME OF THE EVENT. PER REVIEW OF THE PATIENT'S ECG AND DOWNLOADED SOFTWARE FLAG DATA, ASYSTOLE WITH INTERMITTENT CARDIAC ACTIVITY WAS RECORDED AT 19:25:26. THE DEVICE CONTINUED TO DETECT ASYSTOLE UNTIL THE DEVICE WAS SHUTDOWN AT 20:07:17. THE DEVICE PROPERLY DETECTED AND ALARMED FOR ASYSTOLE. ASYSTOLE IS CONSIDERED A NON-SHOCKABLE RHYTHM. A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT WHILE IN A SKILLED NURSING FACILITY. AN ELEVATED HEART RATE CONTRIBUTED TO THE FALSE DETECTION. THE PATIENT WAS REPORTEDLY CONSCIOUS AT THE TIME OF THE EVENT. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE EVENT. THERE IS NO INFORMATION TO SUGGEST THAT THE PATIENT SOUGHT MEDICAL ATTENTION. THE PATIENT CONTINUED USE OF THE LIFEVEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598470 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| O