Complications Associated With Implantable Spinal Cord Stimulator: A Study of FDA Databases From Regulatory Perspective

An adverse event (AE) is any unexpected outcome associated with the use of a medical product in a patient. The tracking and recording of AE are important for reevaluation of safety and effectiveness of medical devices. The response to AE may include recall, which attempts to address the reported problem by repairing, re-labeling, etc. Spinal cord stimulator system (SCS) is an implantable device that sends low levels of electricity directly into the spinal cord to relieve pain, its indications include back pain, postsurgical pain, injuries to spinal cord, etc. As a type of active implantable device, SCS represent relatively high rate of AE. In this article, we analyzed 15 694 AE reports of SCS extracted from the Manufacturer and User Facility Device Experience (MAUDE) database of the United States Food and Drug Administration (FDA) between 1 January 2023 and 30 June 2023. In addition, we analyzed 65 recall reports of SCS extracted from the Recalls of Medical Devices database of FDA from 2005 to 2023 as supplement. The text data in AE dataset has been preprocessed using the natural language toolkit (NLTK), a natural language tool kit in Python. To predict the severity of AE, four classifiers as well as four vectorization methods were applied. The experiment achieved the highest accuracy of 90.6% with eXtreme Gradient Boosting Classifier (XGBC) and unigram. This study proposed an automatic approach of labeling the severity of AE data and conclude that SCS AE often occur when recharging the battery of SCS and when transmitting data via wireless communication route.