The Food and Drug Administration (FDA) is reminding health care providers that before implanting a spinal cord stimulator (SCS), a stimulation trial should be performed on a patient to confirm satisfactory pain relief.
In a letter to health care providers, the Agency reported that between July 27, 2016 and July 27, 2020, a total of 107,728 medical device reports (MDRs) associated with SCS devices intended for pain were received. Among these reports, 497 were associated with patient death. Where time to event was available (30% of the cases), the deaths reportedly occurred within 30 days of implantation; none of these reports could conclusively link the deaths to the device. Additionally, 77,937 of the cases reported on patient injury and 29,294 on device malfunction.
Within these MDRs, the most frequently reported Patient Problem Code (PPC) was failure to achieve or maintain adequate pain control. Other PPCs included pain, unexpected therapeutic effects, infection, and discomfort. The most common Device Problem Codes were associated with battery-powered stimulation devices intended for longer-term implantation and therapy.
Based on its review, the Agency has provided the following additional recommendations to health care providers regarding the importance of conducting a stimulation trial.
- Before permanent SCS implantation, conduct the trial stimulation as described in the device labeling to identify and confirm satisfactory pain relief.
- Permanent SCS should only be implanted in patients who have undergone and passed a stimulation trial.
- A stimulation trial is typically performed on a patient for 3-7 days; success is usually defined by a 50% reduction in pain symptoms. Patients should be informed about the risks of serious side effects and what to expect during the stimulation trial.
- Before implantation of any SCS, benefits and risks of the different types of implants and other treatment options should be discussed.
- Patients should be provided with the manufacturer’s patient labeling and any other educational materials for the device and informed of the risks, benefits and what to expect during the use of the implanted SCS they will receive before implantation.
- An individualized programming, treatment, and follow-up plan for SCS therapy delivery should be developed with each patient.
- Patients should be provided with the name of the device manufacturer, model, and the unique device identifier of the implant they received.
The Agency noted that there are several limitations of mandatory and voluntary reporting of MDRs and that “the submission of an MDR often does not provide enough information to establish a causal relationship between the device and the reported event.”
Any adverse events or suspected adverse events experienced with SCS should be reported to the FDA’s MedWatch Voluntary Reporting program.
For more information visit fda.gov.
- Conduct a Trial Stimulation Period Before Implanting a Spinal Cord Stimulator (SCS) – Letter to Health Care Providers. https://www.fda.gov/medical-devices/letters-health-care-providers/conduct-trial-stimulation-period-implanting-spinal-cord-stimulator-scs-letter-health-care-providers. Accessed September 3, 2020.