BEUDAMED
    FDA Adverse Event Summary report: N

    ACTIGRAPH CENTREPOINT INSIGHT WATCH

    MDR report key: 12719412 · Received October 28, 2021

    Report

    Report Number
    MW5105016
    Date Received
    October 28, 2021
    Date of Event
    September 28, 2021
    Report Date
    October 26, 2021
    Manufacturer
    ACTIGRAPH, LLC
    Product Code
    LEL
    UDI-DI
    00853048008039
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER (RESEARCH COORDINATOR) INFORMED ACTIGRAPH THAT A PARTICIPANT REPORTED FEELING A "SHOCK" WHILE WEARING THE WRIST-WORN DEVICE ON (B)(6) 2021. THE PARTICIPANT DESCRIBED WALKING FROM ONE ROOM IN THEIR HOME TO ANOTHER AREA WHEN THEY RECEIVED AN UNEXPLAINED "SHOCK RUNNING FROM THE WRIST TO THE ELBOW." THE PARTICIPANT REMOVED THE DEVICE FOR THE REMAINDER OF THE DAY, BUT THEY CHOSE TO WEAR THE DEVICE THE NEXT DAY. AT THE TIME OF THIS EVENT, THE PARTICIPANT HAD BEEN WEARING THE DEVICE FOR APPROXIMATELY 5 MONTHS, FOR 20+ HOURS OF WEAR TIME PER DAY, WITH NO PRIOR ISSUES. THE PARTICIPANT DID NOT SEEK IN-PERSON MEDICAL CARE AT THE TIME OF THIS REPORT, AND THE CLINICAL SITE WILL CONTINUE TO MONITOR AND INVESTIGATE THIS EVENT. ACTIGRAPH HAS DEPLOYED WEARABLE ACTIVITY MONITORS FOR OVER 15 YEARS WITH NO PRIOR REPORTS OF THIS NATURE. THIS DEVICE DESIGN IS TESTED FOR ELECTRICAL SAFETY (IEC 60601) VIA A QUALIFIED THIRD-PARTY VENDOR. THE DEVICE UTILIZES A LOW POWER RECHARGEABLE BATTERY (4.2V) EQUIPPED WITH A SAFETY CIRCUIT TO PREVENT DISCHARGE OCCURRENCE. THE DEVICE WILL BE EVALUATED TO COMPLETE THE INVESTIGATION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614322 ACTIGRAPH CENTREPOINT INSIGHT WATCH DEVICE, SLEEP ASSESSMENT LEL ACTIGRAPH, LLC CPW01 9958 00853048008039

    Patients

    Seq Age Sex Outcome Treatment
    1