Home » Spinal-Cord Stimulator Implant

Spinal-Cord Stimulator Implant

• More on Spinal-Cord Stimulator Implant
  • Spinal-Cord Stimulator Implant Lawsuit

Spinal-cord stimulator implants promise drug-free relief from chronic pain. However, a recent investigation suggests the devices may be far more dangerous than many patients realize.

What are Spinal-Cord Stimulator Implants?

For years, medical device manufacturers have marketed spinal-cord stimulators as a near-perfect solution for patients suffering from chronic pain disorders, including:

• Arachnoiditis
• Complex regional pain syndrome (CRPS)
• Failed-back surgery syndrome (FBSS)
• Post-laminectomy syndrome (lumbar or cervical)
• Nerve damage, neuropathy, or neuritis

In general, these systems consist of:

• A surgical lead that is placed into the epidural space of the spinal cord.
• A pulse generator placed into the buttocks or abdomen.
• An external remote to control the implant.

In most cases, spinal-cord simulator systems are implanted in patients who have undergone more conservative treatments without success. Once in place, they emit a low-voltage electrical current that prevents pain signals produced by the spinal cord from reaching the brain.

Following implantation, most patients report feeling a mild tingling sensation where the current is placed.

Popular Spinal-Cord Stimulator Implant Systems

Currently, four medical device manufacturers dominate the spinal-cord stimulator implant market.

Abbott/St Jude:

• Proclaim Elite Recharge-free SCS System
• Prodigy MRI Implantable Pulse Generator
• BURSTDR Stimulation

Boston Scientific:

• Precision Montage MRI Spinal-cord Stimulator System
• Precision Nova Primary Cell Spinal-cord Stimulator System
• Precision Spectra Spinal-cord Stimulator System
• Precision Plus Spinal-cord Stimulator System
• Spectra WaveWriter Spinal-cord Stimulator System

Medtronic:

• INTELLIS Platform
• RESTORESENSOR SURESCAN MRI NEUROSTIMULATOR
• RESTOREULTRA SURESCAN MRI NEUROSTIMULATOR
• RESTOREADVANCED SURESCAN MRI NEUROSTIMULATOR
• PRIMEADVANCED SURESCAN MRI NEUROSTIMULATOR

Nevro:

• HF10 Therapy
• Senza system
• Senza II system

Spinal-Cord Stimulator Implants: What are the Risks?

The risks associated with spinal-cord stimulator implant surgery include:

• Allergic reaction
• Headache
• Infection
• Leakage of spinal cord fluid
• Paralysis and weakness
• Worsened pain
• Stimulation in the wrong area
• Overstimulation
• Inadequate system connection
• Device malfunction
• Lead damage or movement
• Interactions with other devices/procedures

How Safe and Effective are Spinal-Cord Stimulator Implants?

In November 2018, the Associated Press and NBC News raised serious concerns about the safety and effectiveness of spinal-cord stimulator implants. They noted, among other things, that the FDA had received more than 80,000 injury reports involving the devices over the past decade.

At least 500 of these reports involved patients who had died. However, it wasn’t clear if the spinal-cord stimulator or the implant surgery had caused the deaths.

All major models of spinal-cord stimulators were associated with reports of shocking and burning, while infections were the mostly-commonly reported adverse events associated with Boston Scientific devices.

According to many patients, spinal-cord stimulators not only failed to alleviate pain, but actually left them worse off than before their surgeries.

Additionally, the FDA allowed some spinal-cord stimulators to come to market without clinical trials, approving them largely based on studies involving older devices.

What’s more, many spinal-cord stimulator trials were small, industry-funded, and exhibited a substantial placebo effect.

“I don’t know of anyone who is happy with spinal-cord technology as it stands,” Dr. Walter J. Koroshetz, director at the neurological disorders and stroke division at the National Institutes of Health, told the Associated Press. “I think everybody thinks it can be better.”