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Infections, Explants, and Lead Problems With Spinal Cord Stimulators: A Summary of a Real-World Study
Spinal cord stimulation (SCS) uses a small implanted device to treat chronic pain. It has two main parts: thin wires called leads, placed near the spinal cord, and a battery called the implanted pulse generator (IPG). Like any implant, SCS can have problems after placement. A study in Neuromodulation used real-world health records to look at how often some of these problems occur.
This summary is based on the published abstract; the full paper may include additional detail. Read the abstract on PubMed: https://pubmed.ncbi.nlm.nih.gov/37855766/
What was studied
The authors looked at three types of events after SCS: infections, explants (removal of the device), and displacement or mechanical problems with the leads or the battery. They also tested whether these events were becoming more or less common over time.
How it was done
The team used electronic health records from 80 healthcare organizations in the United States, drawn from the TriNetX database. They included 11,934 patients who received SCS for persistent spinal pain syndrome type 2, which is ongoing back or leg pain after spine surgery. They tracked yearly rates of each event over eight years, used statistical tests to look for trends, and built forecasts for the following three years.
Key findings
- Displacement and mechanical problems rose over time. Yearly rates of lead and battery displacement or mechanical problems showed a statistically significant upward trend. This pattern held in men and women, and in smokers and nonsmokers.
- Explants and infections were steady. The authors found no significant time trend for explants or infections.
- Explant was the most frequent event. Across the study period, removal of the device was the most common event the authors tracked.
- Forecasts. For a near-future year, the model predicted lead displacement or mechanical problems at about 3.07%, battery explant at about 2.67%, and lead explant at about 2.02%.
Limitations
- The study relied on health record data, which depend on accurate coding and may miss some events.
- Forecasts are projections based on past patterns, not observed results.
- The abstract does not report the reasons for each explant or how each problem was treated.
- Only patients with pain after spine surgery were included, so results may not apply to every SCS patient.
Safety takeaways
- Device problems can appear long after placement. Follow-up should continue well beyond the first weeks after surgery.
- Lead and battery issues deserve attention. New loss of pain coverage, unusual stimulation, or pain at the device site may signal a mechanical problem and should be checked.
- Infection remains a risk. Patients should know the warning signs, such as redness, drainage, fever, or worsening pain at the incision.
- Informed consent should cover explant and revision. Patients benefit from knowing that some devices are later removed or revised.
- Clear records help. Documenting device checks, symptoms, and imaging supports good communication across the care team.
Reference
- Goudman L, Moens M, Kelly S, Young C, Pilitsis JG. Incidence of Infections, Explantations, and Displacements/Mechanical Complications of Spinal Cord Stimulation During the Past Eight Years. Neuromodulation. 2024;27(6):1082-1089. DOI: 10.1016/j.neurom.2023.09.001. PMID: 37855766. Abstract: https://pubmed.ncbi.nlm.nih.gov/37855766/
Related: Spinal Cord Stimulation and Neuromodulation Cases
This article is educational information, not legal or medical advice.
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