Spinal Cord Stimulation Core Safety and Performance Trending in the Product Surveillance Registry

Introduction: Spinal cord stimulation (SCS) has become a well-established therapy in the treatment of chronic back and leg pain. However, real world long-term data specific to safety and performance trends are needed to provide insight into product outcomes, adverse event occurrence, the long-term risks of surgical intervention in patients receiving the therapy, and to guide the development and improvement of this implantable therapy.

Methods: The Product Surveillance Registry (PSR) is a prospective, long-term, multi-center global registry. The Pain Stimulation (PSTM) module of the PSR was initiated in 2004. The PSR enrolls patients receiving either their first pain stimulation implant or a replacement neurostimulator. Patients are followed prospectively for events related to the device, procedure, and/or therapy. For this analysis, we restricted patient inclusion to those enrolled since 2017 when comprehensive product performance event classification was expanded.
Product Performance events were analyzed and classified into intervention categories such as surgical intervention and re-programming.

Results: We analyzed the incidence of product performance events (PPEs) requiring surgical intervention in patients undergoing pain stimulation therapy between 2017 and 2024 (n=2,310). The most common PPEs requiring surgical revision were lead migration/dislodgement (n = 71; 3.1%) and high impedance (31, 1.3%). Lead fractures resulting in surgical intervention occurred in 0.3% of subjects (n = 7).
Annual rates of product performance events that resulted in surgical intervention ranged from 3.8%-6.1% from 2017-2023 and 1.5% in 2024. Lead fractures remained low and stable throughout the analysis period, occurring at most 0.4% annually. Other adverse events such as device malfunction, high impedance, and inability to recharge the neurostimulator were observed but infrequently led to surgical intervention. Overall, PPEs requiring surgical intervention occurred in 12% (n = 277) of all subjects. Notably, there was a downward trend in surgical intervention rates in the latter years, suggesting improvements in device design, surgical technique, and post-operative care. These findings emphasize the continued need for product surveillance in device placement and follow-up to minimize revision surgeries in pain stimulation therapy.

Conclusion: Information collected in the PSR can be used to better understand the performance and use of SCS systems globally and provide insight into product related issues requiring surgical intervention and related issues with a goal of guiding future product development.