BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC EVENT MONITORING (CEM) B

    MDR report key: 19033381 · Received April 2, 2024

    Report

    Report Number
    MW5153506
    Event Type
    Malfunction
    Date Received
    April 2, 2024
    Date of Event
    February 19, 2024
    Report Date
    March 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC.
    Product Code
    DSI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT STATES THAT HER BATTERY-OPERATED 30-DAY EVENT MONITOR SHE WORE "ELECTROCUTED" HER. PATIENT SELF REPORTED THE EVENT AND ALERTED TO THE POSSIBILITY OF SMALL ELECTRICAL BURN TO THE CHEST AREA WHERE THE MONITOR WAS LOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101705 CARDIAC EVENT MONITORING (CEM) B DETECTOR AND ALARM, ARRHYTHMIA DSI BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC. 2285108

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Other