https://www.fda.gov/medical-devices/letters-health-care-providers/conduct-trial-stimulation-period-implanting-spinal-cord-stimulator-scs-letter-health-care-providers?utm_campaign=FDA%20Stakeholder%20Update%20-%20September%204%2C%202020&utm_medium=email&utm_source=Eloqua

Conduct a Trial Stimulation Period Before Implanting a Spinal Cord Stimulator (SCS) - Letter to Health Care Providers

Conduct a Trial Stimulation Period Before Implanting a Spinal Cord Stimulator (SCS)

The FDA is reminding health care providers of the importance of conducting a trial stimulation period with patients to confirm satisfactory pain relief before implanting a spinal cord stimulator (SCS).

As part of the its ongoing monitoring of the safety and effectiveness of medical devices, including the review of published literature and adverse event and product reports, the FDA continues to receive reports of serious side effects associated with implanted SCS. As a result of this review, the FDA is reminding health care providers of the importance of conducting a stimulation trial before implanting an SCS and providing health care providers with additional recommendations.