BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 13009361 · Received December 15, 2021

    Report

    Report Number
    3008642652-2021-10978
    Event Type
    Death
    Date Received
    December 15, 2021
    Date of Event
    November 13, 2021
    Report Date
    December 14, 2021
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE MONITOR AND ELECTRODE BELT HAS BEEN RETURNED AND THE EVALUATION IS UNDERWAY. THE DEVICE FLAG DATA FROM THE LAST DOWNLOAD ((B)(6) 2021) 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. DEVICE MANUFACTURE DATE: MONITOR 07/21/2020. BELT 08/05/2019.

    Description of Event or Problem · 0

    A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY IN A REHAB FACILITY ON (B)(6) 2021. REVIEW OF THE PATIENT'S DOWNLOAD DATA INDICATES THE PATIENT RECEIVED ONE INAPPROPRIATE SHOCK IN RESPONSE TO OVERSENSING OF LOW AMPLITUDE CARDIAC SIGNAL AND MOTION ARTIFACT ON THE DATE OF PASSING. THE DEVICE WAS STARTED UP AT 14:54:38 ON (B)(6) 2021. THE PATIENT WAS IN SINUS RHYTHM/BRADYCARDIA AT 70 TO 30 BPM AT 18:40:02. THE PATIENT'S RHYTHM DEGRADED TO SEVERE BRADYCARDIA AT 10 BPM WITH UNCONDUCTED P WAVES. THE RHYTHM THEN TRANSITIONS TO AN IDIOVENTRICULAR RHYTHM AT 60 BPM BEFORE DEGRADING BACK TO ASYSTOLE WITH UNCONDUCTED P WAVES BY 18:44:42. THE PATIENT RECEIVED THE INAPPROPRIATE SHOCK AT 19:25:38. THE PATIENT'S RHYTHM AT THE TIME OF THE SHOCK AND POST-SHOCK RHYTHM WERE ASYSTOLE WITH MOTION ARTIFACT. THE PATIENT WAS LAST SEEN IN ASYSTOLE WITH CPR/MOTION ARTIFACT AT 19:30:19. THE ELECTRODE BELT WAS DISCONNECTED AT 19:31:28 ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1905557 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005005

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death