Amanda N. Cooper PhD , Hasan Sen MD , Napatpaphan Kanjanapanang MD , Kristen Saad MD , Garret Wahl MD , Chase Young MD, MPH , Matthew Essman MD, DPT , Alexandra E. Fogarty MD , Taylor Burnham DO, MS , Aaron M. Conger DO , Zachary L. McCormick MD , Allison Glinka Przybysz MD, MPH
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引用次数: 0
Abstract
Summary of Background Data
The use of peripheral nerve stimulation (PNS) devices within pain and spine-related care has increased significantly in recent years. The United States Food and Drug Administration (FDA)–approved indications for PNS have expanded rapidly with technologic advances and randomized controlled trials demonstrating its efficacy. Analysis of real-world data regarding the complications associated with PNS can help inform clinical decision-making and patient counseling as the use of this neuromodulation therapy continues to evolve.
Objectives
This study aimed to categorize adverse events (AEs) described in medical device reports (MDRs) within the FDA Manufacturer and User Facility Device Experience (MAUDE) data base related to the use of PNS for pain and spinal indications.
Materials and Methods
A comprehensive search within the MAUDE data base was conducted to identify AEs related to FDA-approved PNS devices reported between January 1, 2023 and December 31, 2023, specifically to capture AEs related to current PNS technology in clinical use. AEs were manually categorized according to event descriptions.
Results
We identified 594 unique MDRs associated with the five PNS devices currently approved by the FDA for use in the spine. While most MDRs (77.1%) did not specify lead location, spinal lead placements were implicated in 9.1% of cases, and appendicular lead placement accounted for 13.8%. Infection (22.7%), migration (14.7%), and skin erosion (9.4%) were the most common AEs reported. Most entries were categorized as device-related (40.1%) or procedural AEs (32.7%), and the remainder as patient complaints (17.3%), serious AEs (1.0%), and “other” complications (6.1%). Most complications were managed with explantations (43.8%) rather than revisions (29.5%).
Discussion/Conclusion
New technologies and their applications must be regularly evaluated for safety and effectiveness. Our analysis of the MAUDE data base revealed that infection, lead migration, and skin erosion were the most commonly reported AEs associated with the use of PNS technology during 2023. Most AEs were deemed to be device- or procedure-related.
期刊介绍：
Neuromodulation: Technology at the Neural Interface is the preeminent journal in the area of neuromodulation, providing our readership with the state of the art clinical, translational, and basic science research in the field. For clinicians, engineers, scientists and members of the biotechnology industry alike, Neuromodulation provides timely and rigorously peer-reviewed articles on the technology, science, and clinical application of devices that interface with the nervous system to treat disease and improve function.
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