Between July 27, 2016, and July 27, 2020, the US Food and Drug Administration (FDA) received a total of 107,728 medical device reports (MDRs) related to implanted spinal cord stimulators (SCSs), including 497 associated with patients' deaths, 77,937 with patients' injuries, and 29,294 with device malfunction.
As a result, the FDA has sent a letter to healthcare providers reminding them of the importance of conducting a trial stimulation period with patients to confirm adequate pain relief before implanting the device.
Implanted SCSs are used for the management of chronic, intractable pain of the trunk and/or limbs associated with a variety of conditions.
The most frequently reported patient problem ― failure to achieve or maintain adequate pain control (28%) ― highlights the need for patients to undergo and demonstrate an adequate trial stimulation prior to implantation, the FDA says. Other common patient problems included pain (15%), unexpected therapeutic effects (11%), infection (7.5%), and discomfort (6%).
The most frequently reported device problems ― charging problems (11%), impedance (high, low, and/or unspecified, 11%), migration (7%), battery problems (6%), and premature discharge of battery (4%) ― are consistent with those expected with battery-powered stimulation devices intended for longer-term implantation and therapy, the agency notes.
The 497 MDRs coded as a patient death represent 428 unique events reported during the 2016–2020 review period. These events were associated with devices implanted between November 2005 and July 2020.
The patients who died were 69 years old on average and had comorbid conditions, including cancer; chronic diseases, including Parkinson's disease, diabetes, dementia, and heart disease; and acute illness or injury, including influenza, infection, suicide, and substance abuse.
In roughly 30% of the deaths for which times to event were available, the death occurred within 30 days of implantation. "However, none of the reports provide enough information to conclude that the device caused or contributed to the death," the FDA says.
On the basis of the MDRs, the FDA recommends that healthcare providers take the following actions:
Conduct the trial stimulation as described in the device labeling to identify and confirm satisfactory pain relief before permanent SCS implantation.
Only implant permanent SCSs in patients who have undergone and passed a stimulation trial. A stimulation trial usually lasts 3 to 7 days; success is usually defined as a 50% reduction in pain symptoms. Patients should be informed about the risks for serious side effects and what to expect during the trial stimulation.
Before implantation of any SCS, discuss with the patient the benefits and risks of the different types of implants and other treatment options; provide the patient with the manufacturer's patient labeling and any other educational materials for the device that will be implanted; and inform the patient of the risks, benefits, and what to expect during the use of the SCS they will receive.
Develop an individualized programming, treatment, and follow-up plan for SCS therapy delivery with each patient.
Provide the patient with the name of the device manufacturer, the model, and the unique device identifier of the implant they received.
Healthcare professionals and consumers can report adverse reactions or quality problems they experience using the devices to the FDA's MedWatch program.
Cite this: Problems With Implanted Spinal Cord Stimulators Prompt FDA Action - Medscape - Sep 03, 2020.