BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 5900543 · Received August 24, 2016

    Report

    Report Number
    3008642652-2016-05889
    Event Type
    Injury
    Date Received
    August 24, 2016
    Date of Event
    July 23, 2016
    Report Date
    October 10, 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

    ADDITIONAL INFORMATION AND DEVICE EVALUATION: MONITOR SN (B)(4) WAS RETURNED AND EVALUATED AT THE DISTRIBUTOR IN ACCORDANCE WITH ZOLL MANUFACTURING RECOMMENDATIONS. THE REPORTED PROBLEM (PATIENT TREATMENT) HAS BEEN CONFIRMED. AS RECEIVED, THE MONITOR WOULD NOT FULLY POWER ON. UPON EVALUATION, THE MONITOR EXHIBITED A FLASH MEMORY FAILURE AT BGA COMPONENTS U102 AND U105 ON THE COMPUTER/ANALOG BOARD. THE ROOT CAUSE FOR THE FLASH MEMORY FAILURE COULD NOT BE. POSITIVELY IDENTIFIED. THE MONITOR DESIGN CHANGE IN P010030/S039 WAS DETERMINED TO BE EFFECTIVE AT REDUCING THE OCCURRENCE OF FRACTURED BGA'S RESULTING FROM MECHANICAL STRAIN. THERE WAS NO DEATH OR DEVICE MALFUNCTION ASSOCIATED WITH THE INAPPROPRIATE DEFIBRILLATION EVENT. DEVICE EVALUATION SUMMARY: ELECTRODE BELT 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 (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. MONITOR SN (B)(4) HAS NOT YET BEEN RECOVERED FROM THE FIELD. DEVICE EVALUATION OF THE MONITOR INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES (ATTACHED) ON THE DAY OF THE EVENT. 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. DEVICE MANUFACTURE DATE: MONITOR: SN (B)(4): 11/24/2014. ELECTRODE BELT: SN (B)(4): 1/7/2015. 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, SOFTWARE FLAG FILES, AND ECG STRIPS (ATTACHED). THE PRIMARY CAUSE OF THE INAPPROPRIATE SHOCK WAS LACK OF RESPONSE BUTTON USE. THE ECG ANALYSIS, CONDUCTED BY TRAINED ECG TECHNICIANS, IDENTIFIED THE PRIMARY CAUSE OF THE FALSE DETECTION WAS SVT RATE ABOVE THE TREATMENT THRESHOLD. THE RAPID RATE SATISFIED THE RATE DETECTOR OF THE DETECTION ALGORITHM. 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). 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 (B)(4) PERFORMANCE REQUIREMENTS FOR SENSITIVITY AND SPECIFICITY.

    Additional Manufacturer Narrative · 1

    THERE WAS NO DEATH OR DEVICE MALFUNCTION ASSOCIATED WITH THE INAPPROPRIATE DEFIBRILLATION EVENT. DEVICE EVALUATION SUMMARY: ELECTRODE BELT 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 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 MONITOR SN (B)(4) HAS NOT YET BEEN RECOVERED FROM THE FIELD. DEVICE EVALUATION OF THE MONITOR INCLUDED REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAY OF THE EVENT. 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. DEVICE MANUFACTURE DATE: MONITOR: SN (B)(4): 11/24/2014; ELECTRODE BELT: SN (B)(4): 1/7/2015. 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, SOFTWARE FLAG FILES, AND ECG STRIPS. THE PRIMARY CAUSE OF THE INAPPROPRIATE SHOCK WAS LACK OF RESPONSE BUTTON USE. THE ECG ANALYSIS, CONDUCTED BY TRAINED ECG TECHNICIANS, IDENTIFIED THE PRIMARY CAUSE OF THE FALSE DETECTION WAS SVT RATE ABOVE THE TREATMENT THRESHOLD. THE RAPID RATE SATISFIED THE RATE DETECTOR OF THE DETECTION ALGORITHM. 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.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT CONSISTING OF ONE SHOCK. IT WAS REPORTED THAT THE PATIENT WAS CONSCIOUS AND WALKING INTO HIS ROOM AT THE TIME OF THE TREATMENT. THE RESPONSE BUTTONS WERE PRESSED AFTER TREATMENT HAD BEEN DELIVERED. THE RESPONSE BUTTONS FUNCTIONED APPROPRIATELY. RAPID ATRIAL FIBRILLATION (AF) CONTRIBUTED TO THE FALSE DETECTION. THE RAPID RATE SATISFIED THE RATE DETECTOR OF THE DETECTION ALGORITHM. THE PATIENT DID NOT SEEK MEDICAL ATTENTION AND CONTINUES WEARING THE LIFEVEST.

    Description of Event or Problem · 1

    A U.S. DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT EXPERIENCED AN INAPPROPRIATE DEFIBRILLATION EVENT CONSISTING OF ONE SHOCK. IT WAS REPORTED THAT THE PATIENT WAS CONSCIOUS AND WALKING INTO HIS ROOM AT THE TIME OF THE TREATMENT. THE RESPONSE BUTTONS WERE PRESSED AFTER TREATMENT HAD BEEN DELIVERED. THE RESPONSE BUTTONS FUNCTIONED APPROPRIATELY. RAPID ATRIAL FIBRILLATION (AF) CONTRIBUTED TO THE FALSE DETECTION. THE RAPID RATE SATISFIED THE RATE DETECTOR OF THE DETECTION ALGORITHM. THE PATIENT DID NOT SEEK MEDICAL ATTENTION AND CONTINUES WEARING THE LIFEVEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551593 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other