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# Trial Should Precede Spinal Cord Stimulator Implant: FDA
- URL: https://www.fdaweb.com/trial-should-precede-spinal-cord-stimulator-implant-fda/
- Published: 2020-09-03T12:00:00.000Z
- Updated: 2026-09-14T16:27:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147579

FDA is reminding healthcare providers that it is important to conduct a trial stimulation period with patients to confirm satisfactory pain relief before implanting a spinal cord stimulator (SCS). An agency letter to healthcare providers [says](https://www.fda.gov/medical-devices/letters-health-care-providers/conduct-trial-stimulation-period-implanting-spinal-cord-stimulator-scs-letter-health-care-providers?utm%5Fcampaign=2020-09-03%20Conduct%20a%20Trial%20Stimulation&utm%5Fmedium=email&utm%5Fsource=Eloqua) that as part of FDA’s ongoing monitoring of the safety and effectiveness of medical devices, it continues to receive reports of serious side effects associated with implanted SCS.

“As a result of this review,” the letter says, “FDA is reminding healthcare providers of the importance of conducting a stimulation trial before implanting an SCS and providing healthcare providers with additional recommendations.”

The letter includes specific recommendations for healthcare providers, background information, and tables of the most frequently reported patient problem codes and device problem codes.