The FDA has sent a letter to healthcare providers to remind them of the importance of a trial stimulation period for patients to confirm adequate pain relief before implanting a spinal cord stimulator, Medscape reported Sept. 3.
Between July 27, 2016, and July 27, 2020, the FDA received 107,728 medical device reports related to spinal cord stimulators, including 497 associated with patient deaths, 77,937 with injuries and 29,294 with device malfunction.
Twenty-eight percent of the reports cited failure to achieve or maintain adequate pain relief — the most frequently reported issue — reaffirming the need for patients to have a trial stimulation before implantation, the FDA said.
Patients also reported problems with unexpected therapeutic effects, infection and discomfort. Common device problems included charging issues, impedance, migration and battery problems.
To avoid complications, the FDA has recommended that providers only implant spinal cord stimulators in patients who have passed a stimulation trial, discuss the risks and benefits with each patient before implantation and create patient-specific programming, treatment and follow-up plans.