Spinal cord stimulators are medical devices that treat pain, but they can also have severe side effects like burns, electric shocks, device migration, and more.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Spinal Cord Stimulator induced injury cases in all 50 states. If you or somebody you know was injured by a spinal cord stimulator, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
What is a Spinal Cord Stimulator?
A spinal cord stimulator is an implanted medical device that sends low-level electrical shocks directly into the spinal cord to relieve pain. The patient uses a remote control to send electrical impulses to the spinal cord stimulator device whenever they feel pain, which replaces the pain with a light tingling sensation.
What is the Problem?
Spinal cord stimulators can dramatically improve a patient’s quality of life and their ability to sleep, while also reducing their need for pain medications. However, these devices can also potentially cause severe side effects. Spinal cord stimulators can break, damage the spinal cord, fail to stop the pain due to incorrect placement, move out of position, or cause other painful injuries that require revision surgery.
Electrode Migration
One of the most common problems with spinal cord stimulators is device migration. This occurs when the electrodes move out of position, so the stimulator does not block pain very well. It requires a follow-up surgery to put the electrodes back into the proper position.
What is the Risk?
- Unsatisfactory pain relief
- Worse pain
- Needing another surgery
- Burning
- Electric shock by the device
- Lead wire fracture
- Gastroparesis (“stomach paralysis”)
- Dysphagia
- Uncontrollable diarrhea (fecal incontinence)
- Dizziness / fainting
- Heart problems (cardiac arrhythmia)
- Electrode migration
- Dural puncture
- Spinal cord trauma
- Nerve damage
- Paralysis
FDA Warning: Spinal Cord Stimulators Linked to 428 Deaths
In September 2020, the FDA published a Letter to Healthcare Providers with warnings about hundreds of deaths, injuries, and malfunctions involving spinal cord stimulators. The FDA received 428 reports of patient deaths involving spinal cord stimulators, according to MedTech Dive.
What Patients Need Spinal Cord Stimulators?
Spinal cord stimulators are used after non-surgical pain treatments have failed. These devices are typically implanted in patients with back pain, especially pain that continues after surgery and non-surgical pain treatments have failed. They may also be used in people with nerve pain from diabetes, cancer, spinal cord injuries, and more.
Who Makes Spinal Cord Stimulators?
The companies who manufacture spinal cord stimulators include:
- Abbott
- Biotronik NRO Inc.
- Boston Scientific
- Medtronic
- Nevro Corporation
- Saluda Medical
- St. Jude
Examples of Spinal Cord Stimulation (CSC) Systems
In January 2022, the FDA approved the Senza Spinal Cord Stimulation (SCS) System manufactured by Nevro Corporation.
In February 2022, the FDA approved the Evoke Spinal Cord Stimulation (SCS) System manufactured by Saluda Medical.
In October 2022, the FDA approved an AI-based spinal cord stimulation device for chronic pain called the Senza HFX iQ Spinal Cord Stimulation (SCS) System, which is manufactured by Nevro Corp.
In February 2023, the FDA approved Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS) Systems manufactured by Abbott.
In March 2023, the FDA approved Prospera Spinal Cord Stimulation (SCS) System manufactured by Biotronik NRO Inc.
In February 2024, the FDA approved the WaveWriter Spinal Cord Stimulation (SCS) System manufactured by Boston Scientific for the treatment of chronic low back and leg pain in people without prior back surgery.
In April 2024, the FDA approved the Inceptiv™ closed-loop rechargeable spinal cord stimulator (SCS) for the treatment of chronic pain. It is manufactured by Medtronic.
Do I have a Spinal Cord Stimulator Lawsuit?
The Schmidt Firm, PLLC is currently accepting Spinal Cord Stimulator induced injury cases in all 50 states. If you or somebody you know was injured by a spinal cord stimulator, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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