Complications Associated With Use of Peripheral Nerve Stimulators for Pain Management

OBJECTIVE: Peripheral nerve stimulators (PNS) are neuromodulation devices indicated for pain management. PNS advancements including miniaturized and partially externalized devices have led to increased utilization. Sound evidence supports PNS for pain management, and associated complications are typically modest. However, few studies have examined which PNS-related complications arise most frequently, or relative complication type frequencies between PNS devices. We characterized the most common complications that emerged from PNS use, for 4 commercially available PNS devices. METHODS: We queried the FDA Manufacturer and User Device Experience (MAUDE) database for adverse event reports related to SPRINT PNS, Nalu Neurostimulation System, StimQ PNS/Freedom PNS, and Stimrouter from 3/14 to 3/24. Duplicate entries were removed, then entries were categorized using event descriptions. Analyses were performed using Microsoft Excel and RStudio. RESULTS: Of 1149 unique reports, procedural complications were most common (31.3%), followed by device-related complications (30.9%), and patient complaints (24.02%). Reports that did not fit the categories described were "Other" complications (10.97%). The most common procedural complications were infections (26.8%), and the most common device-related complications were lead migration (10.5%), erosion (8.09%), and electric shock (4.53%). Explant was the most common management technique (46.3%). Other nonsurgical management (22.9%) and surgical revision (17.7%) were also common. DISCUSSION: This analysis aimed to inform the safe utilization of PNS for pain management. Infections made up a larger proportion of complications than previously reported, revealing a need for stricter patient selection and infection prevention techniques.