Adverse Events Associated With Peripheral Nerve Stimulation: An Analysis of the MAUDE Data base and Implications for Pain and Spine Clinicians.

Abstract

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.