BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 8620567 · Received May 17, 2019

    Report

    Report Number
    3008642652-2019-03002
    Event Type
    Death
    Date Received
    May 17, 2019
    Date of Event
    December 2, 2018
    Report Date
    May 17, 2019
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005005
    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

    DEVICE EVALUATION OF MONITOR SN: (B)(4) IS CURRENTLY UNDERWAY. REVIEW OF THE DOWNLOADED DATA FLAGS CONFIRMED THE PULSE RESET IN THE FIELD. THE ROOT CAUSE FOR THE RESET WAS ISOLATED TO NOISE ORIGINATING FROM THE DEFIBRILLATOR PCA HIGH-VOLTAGE CAPACITORS AND PROPAGATING ON THE MAIN BATTERY WIRE ON THE MONITOR C/A BOARD. A DESIGN CHANGE TO ADDRESS THIS CONDITION (PMA SUPPLEMENT: P010030/S064) WAS APPROVED BY FDA ON 11/06/2015. 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 INAPPROPRIATE TREATMENT OR PATIENT DEATH. MANUFACTURE DATES: MONITOR: 9/1/2015; ELECTRODE BELT: 2/22/2013.

    Description of Event or Problem · 1

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY ON (B)(6) 2018 WHILE WEARING THE LIFEVEST. IT WAS REPORTED THAT THE PATIENT WAS FOUND WITH GEL ON HIS BODY, AND THE SOFTWARE FLAG FILES INDICATE THAT THE ELECTRODE BELT HAD DEPLOYED GEL. FURTHER REVIEW OF THE SOFTWARE FLAG FILES AND ECG RECORDINGS INDICATED THAT AT 3:30:12 AM ON (B)(6) 2018, THE PATIENT'S RHYTHM WAS ATRIAL FIBRILLATION (AF) AT 170 BPM WITH FREQUENT PVCS. THE LIFEVEST DETECTED THE ELEVATED RATE AND STARTED A DETECTION SEQUENCE. REVIEW OF THE PATIENT'S DOWNLOADED SOFTWARE FLAG DATA AND LONG TERM ECG DATA INDICATED THAT THE PATIENT WAS TREATED, HOWEVER THE IMMEDIATE POST-SHOCK RHYTHM IS NOT KNOWN AS A RESULT OF THE MONITOR RESETTING IMMEDIATELY AFTER DELIVERING THE TREATMENT AT APPROXIMATELY 3:31:57 AM. THE ECG RECORDINGS INDICATE THAT THE PATIENT WAS IN AF AT 170 BPM WITH FREQUENT PVCS AT THE TIME OF THE TREATMENT. RAPID RATE ABOVE THE TREATMENT THRESHOLD AND MULTIPLE COUNTING CONTRIBUTED TO THE FALSE DETECTION. THE RESPONSE BUTTONS WERE NOT PRESSED DURING THE TREATMENT EVENT. THE LONGTERM ECG RECORDINGS INDICATED THAT AFTER THE TREATMENT WAS DELIVERED, THE PATIENT'S RHYTHM WAS SINUS TACHYCARDIA AT 140 BPM AT ABOUT 3:31 AM. THE ECG RECORDINGS SHOW THAT THE PATIENT'S RHYTHM BECAME IRREGULAR AROUND 06:07 AM AND THEN SLOWED TO SEVERE BRADYCARDIA AROUND 06:13 AM. THE RHYTHM DEGRADED TO ASYSTOLE AT 06:14:24 AM. AT 06:14:54 AM, AN IDIOVENTRICULAR RHYTHM BEGAN THAT DEGRADED INTO VENTRICULAR FIBRILLATION (VF) WITH A FUNDAMENTAL FREQUENCY NEAR 2 HZ (ABOUT 120 BPM, BELOW THE TREATMENT THRESHOLD OF 200 BPM FOR VENTRICULAR FIBRILLATION) BEFORE BECOMING ASYSTOLE AT 06:17:04 AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413757 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death| O