BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 10404796 · Received August 13, 2020

    Report

    Report Number
    3008642652-2020-07042
    Event Type
    Death
    Date Received
    August 13, 2020
    Date of Event
    July 6, 2020
    Report Date
    August 13, 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

    ELECTRODE BELT SN (B)(4) HAS NOT YET BEEN RECOVERED FROM THE FIELD. DEVICE EVALUATION 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 PATIENT DEATH. 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 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. DEVICE MANUFACTURER DATE: MONITOR: 04/06/2015, ELECTRODE BELT: 05/26/2010.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT HAD PASSED AWAY ON (B)(6) 2020. IT WAS REPORTED THAT THE PATIENT'S PASSING WAS CARDIAC RELATED. A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY ON (B)(6) 2020. CLINICAL REVIEW OF THE DOWNLOAD DATA, INDICATES THE PATIENT EXPERIENCED AN APPROPRIATE TREATMENT EVENT CONSISTING OF SIX SHOCKS. THE FIRST FIVE TREATMENTS OCCURRED AT 07:20:22, 07:20:57, 07:23:48, 07:26:19, 07:31:11 ALL WHILE THE PATIENT'S RHYTHM AT THE TIME OF THE TREATMENTS WAS VENTRICULAR FIBRILLATION (VF). THE POST SHOCK RHYTHM FOR TREATMENT ONE WAS SINUS BRADYCARDIA AT 20 BPM WITH PVC DEGRADES TO VF, TREATMENT TWO WAS SINUS BRADYCARDIA @ 15-25 BPM WITH MOTION ARTIFACT, TREATMENT THREE WAS SINUS BRADYCARDIA AT 35 BPM WITH HB, TREATMENT FOUR WAS SINUS BRADYCARDIA AT 15-35 BPM WITH HB, AND TREATMENT FIVE WAS SINUS BRADYCARDIA AT 30 BPM WITH HB AND PVC. TREATMENT SIX OCCURRED AT 07:33:46 WHEN THE PATIENT'S RHYTHM WAS VENTRICULAR TACHYCARDIA (VT) AT 270 BPM, AND THE POST-SHOCK RHYTHM WAS SINUS BRADYCARDIA AT 30 BPM WITH HB AND PVC. THE PATIENT'S ARRHYTHMIAS WERE SUCCESSFULLY CONVERTED TO A SLOWER RHYTHM AS A RESULT OF THE FIRST FIVE TREATMENT EVENTS. THE PATIENT ENTERED AN ARRYTHMIA AT 07:46:02 AND THE ECG SHOWS ASYSTOLE WITH MOTION ARTIFACT. THE PATIENT RECEIVED FIVE ADDITIONAL SHOCKS IN RESPONSE TO CPR/MOTION ARTIFACT AND AMPLITUDE OVERSENSING. TREATMENT SEVEN OCCURRED AT 07:46:46 WHILE THE PATIENT'S RHYTHM WAS ASYSTOLE WITH AMPLITUDE OVERSENSING, AND THE POST SHOCK RHYTHM AS ASYSTOLE. TREATMENT EIGHT OCCURRED AT 07:47:13 WHEN THE PATIENT'S RHYTHM WAS ASYSTOLE WITH MOTION ARTIFACT AND THE POST-SHOCK RHYTHM WAS ASYSTOLE. AT 07:53:12, THE PATIENT RECEIVED A NINTH TREATMENT WHILE THE RHYTHM WAS CPR ARTIFACT AND THE POST-SHOCK RHYTHM WAS ASYSTOLE. TREATMENT TEN WAS AT 07:53:40 WHILE THE PATIENT'S RHYTHM WAS ASYSTOLE WITH CPR ARTIFACT AND THE POST-SHOCK RHYTHM WAS ASYSTOLE. THE PATIENT EXPERIENCED AN ELEVENTH TREATMENT AT 07:59:09 WHEN THE RHYTHM WAS ASYSTOLE WITH CPR ARTIFACT, AND THE POST-SHOCK RHYTHM WAS ASYSTOLE WITH MOTION ARTIFACT AND ECG DISCONNECTION. THE PATIENT WAS IN ASYSTOLE WITH MOTION ARTIFACT AT THE TIME OF THE NON-TREATABLE RHYTHM AT 07:54:16 ON (B)(6) 2020. THERE IS NO INDICATION THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865960 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death