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

On September 3, 2020, the U.S. Food and Drug Administration (FDA) reminded health care providers of the importance of conducting a trial stimulation period to allow patients to confirm satisfactory pain relief before implanting a spinal cord stimulator (SCS).

The FDA reminder covers important information about SCS, including:

• Recommendations for health care providers to consider before SCS implantation.
• Recommended topics for patient-doctor communication.
• Actions the FDA has taken to evaluate information included in SCS medical device reports.
• Instructions for reporting problems with a SCS device.

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