BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 10968251 · Received December 8, 2020

    Report

    Report Number
    3008642652-2020-10876
    Event Type
    Death
    Date Received
    December 8, 2020
    Date of Event
    October 24, 2020
    Report Date
    December 15, 2020
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT 12/15/2020: DEVICE EVALUATION OF BELT SN (B)(6) HAS BEEN COMPLETED.  THE REPORTED PROBLEM (PATIENT DEATH) WAS CONFIRMED. 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. THE PULSE DELIVERY CIRCUITRY TEST VERIFIED PROPER DELIVERY OF A FULL ENERGY 150J BIPHASIC PULSE. THE FUNCTIONAL TESTING CONFIRMED PROPER ECG ACQUISITION AND PULSE DELIVERY FUNCTIONALITY. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. DEVICE EVALUATION OF MONITOR SN (B)(6) HAS BEEN COMPLETED. 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. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. THE ELECTRODE BELT SN (B)(6) WAS RETURNED TO ZOLL MANUFACTURING CORPORATION. INVESTIGATION IS UNDERWAY. THE DEVICE FLAG DATA FROM THE LAST DOWNLOAD DOES NOT INDICATE ANY DEVICE MALFUNCTION. THE REVIEW OF THE DATA INDICATED THAT THE DEVICE POWERED ON NORMALLY AND WAS ABLE TO ACQUIRE THE PATIENT'S ECG SIGNAL ON THE LAST DAY OF USE CAPTURED IN THE DATA DOWNLOAD. NO DEFICIENCIES ALLEGED.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT 12/15/2020: PER CLINICAL REVIEW OF CONTINUOUS ECG DATA, AFTER THE TREATMENT EVENTS, A NON-TREATABLE RHYTHM WAS DECLARED AT 14:51:57. AT 15:33:54, THE DEVICE DETECTED ASYSTOLE. ECG SHOWS VENTRICULAR FIBRILLATION (VF) WITH ELECTRODE LEAD FALL OFF. THE PATIENT WAS IN SINUS TACHYCARDIA AT 100 BPM DEGRADING TO VENTRICULAR TACHYCARDIA (VT) FROM 150 BPM TO 220 BPM WITH VARYING AMPLITUDES, VARYING HEART RATE AND CPR/MOTION ARTIFACT. THE RHYTHM THEN SLOWS TO VT AT 150 BPM AND FURTHER SLOWED TO VT AT 100 BPM WITH CPR/MOTION ARTIFACT AND ELECTRODE LEAD FALL OFF. THE RHYTHM THEN DEGRADED TO VF WITH ELECTRODE LEAD FALL OFF FROM APPROXIMATELY 14:50:58 UNTIL THE DEVICE SHUTDOWN AT 15:38:08 ON (B)(6)2020. VARYING AMPLITUDES, VARYING HEART RATE FLUCTUATING ABOVE AND BELOW THE PRESCRIBED PROGRAMMED RATE THRESHOLD, AND CPR/MOTION ARTIFACT, AND ELECTRODE LEAD FALL OFF PREVENTED THE LIFEVEST FROM TREATING THE PATIENT FROM APPROXIMATELY 14:50:58 TO 15:38:08. A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY WHILE WEARING THE LIFEVEST ON (B)(6) 2020. THE PATIENT WAS IN THE HOSPITAL AT THE TIME OF PASSING. THE PATIENT'S NURSE REPORTED THAT THE PATIENT WAS TREATED BY THE LIFEVEST 3 TIMES AND THEN THE DEVICE WAS REMOVED BY HOSPITAL STAFF TO START CPR. REVIEW OF THE DOWNLOAD DATA, INDICATES THE PATIENT ACTUALLY RECEIVED FIVE INAPPROPRIATE SHOCKS IN RESPONSE TO AMPLITUDE OVERSENSING AND MULTIPLE COUNTING. IT WAS REPORTED THAT THE PATIENT WAS CONSCIOUS BUT NOT COHERENT AT THE TIME OF THE FIVE SHOCKS. THE LIFEVEST DELIVERED FIVE SHOCKS BETWEEN 14:40:42 AND 14:42:49 WHILE THE PATIENT WAS IN AN IDIOVENTRICULAR RHYTHM FROM 80-90 BPM. THE PATIENT'S POST SHOCK RHYTHM FOR ALL SHOCKS WAS IDIOVENTRICULAR RHYTHM FROM 70-80 BPM, WHICH IS A LIFE SUSTAINING RHYTHM. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE EVENT. THE PATIENT PASSED AWAY ON (B)(6)2020 AT APPROXIMATELY 3:04 PM.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED.  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.  THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. THE ELECTRODE BELT SN (B)(4) WAS RETURNED TO ZOLL MANUFACTURING CORPORATION. INVESTIGATION IS UNDERWAY. THE DEVICE FLAG DATA FROM THE LAST DOWNLOAD DOES NOT INDICATE ANY DEVICE MALFUNCTION. THE REVIEW OF THE DATA INDICATED THAT THE DEVICE POWERED ON NORMALLY AND WAS ABLE TO ACQUIRE THE PATIENT'S ECG SIGNAL ON THE LAST DAY OF USE CAPTURED IN THE DATA DOWNLOAD. NO DEFICIENCIES ALLEGED.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY WHILE WEARING THE LIFEVEST ON (B)(6) 2020. THE PATIENT WAS IN THE HOSPITAL AT THE TIME OF PASSING. THE PATIENT'S NURSE REPORTED THAT THE PATIENT WAS TREATED BY THE LIFEVEST 3 TIMES AND THEN THE DEVICE WAS REMOVED BY HOSPITAL STAFF TO START CPR. REVIEW OF THE DOWNLOAD DATA, INDICATES THE PATIENT ACTUALLY RECEIVED FIVE INAPPROPRIATE SHOCKS IN RESPONSE TO AMPLITUDE OVERSENSING AND MULTIPLE COUNTING. IT WAS REPORTED THAT THE PATIENT WAS CONSCIOUS BUT NOT COHERENT AT THE TIME OF THE FIVE SHOCKS. THE LIFEVEST DELIVERED FIVE SHOCKS BETWEEN 14:40:42 AND 14:42:49 WHILE THE PATIENT WAS IN AN IDIOVENTRICULAR RHYTHM FROM 80-90 BPM. THE PATENT'S POST SHOCK RHYTHM FOR ALL SHOCKS WAS IDIOVENTRICULAR RHYTHM FROM 70-80 BPM, WHICH IS A LIFE SUSTAINING RHYTHM. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE EVENT. THE PATIENT PASSED AWAY ON (B)(6)2020 AT APPROXIMATELY 3:04 PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1432485 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H