Adverse Events Associated With Electrodes of Electrocardiographs in MAUDE Analysis
Author(s)
Deeksha S, PharmD1, Ajoshson John, PharmD2, Adusumilli Pramod Kumar, Ph.D3, JEESA GEORGE, M Pharm3.
1Student, M S Ramaiah University Of Applied Sciences, Bengaluru, India, 2M S Ramaiah University Of Applied Sciences, Bengaluru, India, 3M S Ramaiah University Of Applied Sciences, Bangalore, India.
1Student, M S Ramaiah University Of Applied Sciences, Bengaluru, India, 2M S Ramaiah University Of Applied Sciences, Bengaluru, India, 3M S Ramaiah University Of Applied Sciences, Bangalore, India.
OBJECTIVES: Electrodes of electrocardiographs (ECGs) are widely used for cardiac monitoring and diagnosis in clinical settings. Given their frequent application, it is essential to understand the associated risks and adverse outcomes. This study aims to evaluate adverse events related to ECG electrodes reported in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, with the goal of identifying common device issues, patient complications, and reporting patterns.
METHODS: A retrospective analysis was conducted using the MAUDE database covering the period from January 1, 2014, to November 25, 2024. Reports involving ECG electrodes were identified and reviewed. Events were categorized by type (e.g., injury, malfunction), device-related problems, patient complications, and manufacturer involvement. Descriptive statistics were applied to characterize reporting trends and outcomes.
RESULTS: A total of 633 adverse event reports involving ECG electrodes were identified. Injuries accounted for the majority (372/633) of reports. The most frequently cited device-related problem was “Insufficient Information” (152/633), followed by “Adverse Event without Identified Device or Use Problem” (106/633). Among patient-related outcomes, 107 reports indicated “No Clinical Signs, Symptoms, or Conditions,” while 49 cases reported skin irritation. LEONHARD LANG GMBH was the manufacturer with the highest number of reports (133/633). One event described complications during a scheduled MRI. Devices were classified as Class 2, non-implantable, and not intended for life-sustaining functions.
CONCLUSIONS: Adverse events associated with ECG electrodes highlight the importance of consistent monitoring and compliance with safety protocols in clinical environments. While limitations such as underreporting and data completeness exist, the MAUDE database continues to serve as a key surveillance tool. Ongoing evaluation and improved reporting practices are critical to ensuring device safety and optimizing patient outcomes.
METHODS: A retrospective analysis was conducted using the MAUDE database covering the period from January 1, 2014, to November 25, 2024. Reports involving ECG electrodes were identified and reviewed. Events were categorized by type (e.g., injury, malfunction), device-related problems, patient complications, and manufacturer involvement. Descriptive statistics were applied to characterize reporting trends and outcomes.
RESULTS: A total of 633 adverse event reports involving ECG electrodes were identified. Injuries accounted for the majority (372/633) of reports. The most frequently cited device-related problem was “Insufficient Information” (152/633), followed by “Adverse Event without Identified Device or Use Problem” (106/633). Among patient-related outcomes, 107 reports indicated “No Clinical Signs, Symptoms, or Conditions,” while 49 cases reported skin irritation. LEONHARD LANG GMBH was the manufacturer with the highest number of reports (133/633). One event described complications during a scheduled MRI. Devices were classified as Class 2, non-implantable, and not intended for life-sustaining functions.
CONCLUSIONS: Adverse events associated with ECG electrodes highlight the importance of consistent monitoring and compliance with safety protocols in clinical environments. While limitations such as underreporting and data completeness exist, the MAUDE database continues to serve as a key surveillance tool. Ongoing evaluation and improved reporting practices are critical to ensuring device safety and optimizing patient outcomes.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
RWD11
Topic
Clinical Outcomes, Epidemiology & Public Health, Real World Data & Information Systems
Disease
Cardiovascular Disorders (including MI, Stroke, Circulatory), Injury & Trauma, No Additional Disease & Conditions/Specialized Treatment Areas, Sensory System Disorders (Ear, Eye, Dental, Skin)