BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 10374271 · Received August 6, 2020

    Report

    Report Number
    3008642652-2020-06673
    Event Type
    Death
    Date Received
    August 6, 2020
    Date of Event
    June 7, 2020
    Report Date
    July 31, 2020
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    PMA / PMN Number
    P010030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) 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. 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. THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. ELECTRODE BELT SN (B)(4) HAS NOT BEEN RETURNED FOR EVALUATION. DEVICE EVALUATION INCLUDES REVIEW OF DOWNLOADED SOFTWARE FLAG FILES ON THE DAYS SURROUNDING 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 PATIENT TREATMENT. MANUFACTURE DATE: MONITOR - (B)(4) - 09/13/2019, BELT - (B)(4) - 12/04/2013.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY ON (B)(6) 2020. CLINICAL REVIEW OF THE PATIENT'S DOWNLOAD DATA REVEALS THAT THE PATIENT EXPERIENCED AN INAPPROPRIATE TREATMENT EVENT CONSISTING OF ONE SHOCK ON (B)(6), THE DATE OF THEIR PASSING. AT 21:22:11 ON (B)(6), THE LIFEVEST DETECTED AN ARRHYTHMIA. THE PATIENT'S RHYTHM WAS VENTRICULAR FIBRILLATION (VF). AT 21:23:10, THE PATIENT RECEIVED A TREATMENT. THE PATIENT'S RHYTHM AT THE TIME OF THE TREATMENT AND POST SHOCK RHYTHM WAS AN IDIOVENTRICULAR RHYTHM FROM 20-50 BPM. OVERSENSING OF LOW AMPLITUDE CARDIAC SIGNAL CONTRIBUTED TO THE FALSE DETECTION. PER THE CONTINUOUS ECG RECORDINGS, FOLLOWING THE TREATMENT THE PATIENT WAS SEEN IN IDIOVENTRICULAR RHYTHM AT 70 BPM SLOWING TO 15 BPM AND THEN DEGRADING TO ASYSTOLE. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE EVENT. THE ELECTRODE BELT WAS DISCONNECTED AT 21:27:20 ON (B)(6). THE PATIENT SUBSEQUENTLY PASSED AWAY. THERE IS NO INDICATION THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE PATIENT'S TREATMENT OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838894 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death| O