Complications Associated With Use of Peripheral Nerve Stimulators for Pain Management

Area of Science:

• Neuromodulation
• Pain Management
• Medical Device Safety

Background:

• Peripheral nerve stimulators (PNS) are increasingly used for pain management.
• Advancements in miniaturized and partially externalized devices have driven PNS utilization.
• While generally safe, specific complication frequencies require detailed examination.

Purpose of the Study:

• To characterize the most frequent complications associated with peripheral nerve stimulator (PNS) use.
• To compare complication types across four commercially available PNS devices.
• To inform safe utilization of PNS for pain management.

Main Methods:

• Analysis of FDA MAUDE database adverse event reports for four PNS devices (SPRINT®, Nalu, StimQ®/Freedom®, Stimrouter®).
• Data collected from March 2014 to March 2024.
• Categorization of 1,149 unique reports by event description using Microsoft Excel and RStudio.

Main Results:

• Procedural complications (31.3%) were most frequent, primarily infections (26.8%).
• Device-related complications (30.9%) included lead migration (10.5%) and erosion (8.09%).
• Explant (46.3%) was the most common management strategy, followed by nonsurgical management (22.9%) and surgical revision (17.7%).

Conclusions:

• Infections represent a significant proportion of PNS complications, higher than previously reported.
• Stricter patient selection and enhanced infection prevention protocols are necessary for safe PNS use.
• Understanding complication profiles aids in optimizing pain management strategies with PNS devices.