Defective Spinal Cord Stimulators Lawsuit Lawyers

Examples of the harm that could occur due to defective spinal cord stimulators include the following:

• Burning or electric shock caused by the device
• Cardiac arrhythmia
• Cognitive issues
• Dizziness or fainting
• Dysphagia (difficulty swallowing food/liquids)
• Fecal incontinence
• Gastroparesis
• Lead wire fracture or migration
• Urinary incontinence or urinary retention
• Worsening pain

Spinal cord stimulators are devices that are surgically installed into the body to address chronic back pain. The devices have wires that send electric impulses to the spinal cord to block pain signals to the brain. There are three different types of spinal cord stimulators. Radiofrequency stimulators are often used during trial periods (to ensure that a stimulator will help patients); these are battery-powered with an external battery. Conventional implantable pulse generators are battery-powered, have implanted batteries that must be replaced, address a single pain point, and have permanent electric leads (or wires). Rechargeable implantable pulse generators are battery-powered, have implanted batteries that can be recharged, address multiple pain points, and have permanent electric leads with a longer reach.

How these medical devices work – Spinal cord stimulators consist of a battery and wire leads. The wire leads are implanted between the spinal cord and vertebrae; wire leads are connected to the battery, allowing electrical impulses to be sent to the nerve endings directly at the pain site.

The battery is implanted in the body and is controlled by a remote that patients can use to start/control electrical impulses as necessary for pain.

What conditions are spinal cord stimulators used for? – Spinal cord stimulators can be used for many medical conditions that may result in chronic pain. Some of these conditions may include spinal cord injuries, arachnoiditis, chronic back pain, nerve-related pain or nerve injuries, post-surgical pain, complex regional pain syndrome (CRPS), post-amputation pain (commonly referred to as phantom limb), and more.

The main problem with these medical devices is that many models are simply not compliant with FDA regulations. These regulations are in place to ensure that patients are not at risk of suffering significant injury due to the products. For example, the FDA requires that the electrical impulses through lead wires remain below 18 Ohms to avoid permanent damage or severe burns to nerves and tissue. The FDA also requires that the maximum temperature reached by the pulse generators (or the batteries) not exceed 42 degrees to avoid overheating, burns, and nerve/tissue damage.

In addition, the companies that manufacture these spinal cord stimulators have repeatedly failed to report adverse effects or complications that arise because of the use of the medical devices; this means that dangers/risks are significantly underreported. Also, patients are generally misled by sales reps that work for the manufacturers. These sales reps promise patients permanent pain relief but misrepresent the risks that exist.

Patients agree to these complex medical devices without fully understanding the dangers present and any future implications (i.e. complicated procedures to remove leads, the risk of paralysis, making them ineligible for certain surgeries, and preventing them from getting MRIs, and more). Even if patients try to do their own research, they will likely come across misleading information, since manufacturers do not comply with FDA regulations and underreport issues, as explained above.

• Abbott (models include Prodigy, Proclaim, Eterna OG, Eterna Genesis, Axium, and Eterna Eon)
• Boston Scientific (model Precision)
• Medtronic (model Intellis)
• Nevro (model Senza)

Example of a recall – The latest recall involving spinal cord stimulators was issued in July 2023; the recall involved seven different models of the Abbott Proclaim and Infinity medical devices. The recall affected over 155,000 devices and was associated with 186 incidents and 73 injuries. The medical devices was recalled because patients were unable to exit MRI mode once activating it to disable the product during a scan; this resulted in patients requiring surgery to remove/replace the device.

Yes, you could have the right to file a lawsuit. Depending on your specific situation, you may have the right to file a lawsuit against the negligent manufacturer of the medical device (for failing to ensure that their products are free of any defects in manufacturing, design, or labeling, for example). However, negligent medical professionals (hospitals and doctors, alike) can also be sued – especially if they knowingly recommended a defective spinal cord stimulator. For more information about your right to file a lawsuit, please do not hesitate to reach out to our legal team. Our lawyers here at the Downtown L.A. Law Group are ready to guide you every step of the way.

You could be entitled to receive compensation. Although every claim is different, you could be entitled to receive compensation for the harm that you or a loved one suffered. Although every situation is different, you could be entitled to receive compensation for all medical costs, lost income, pain and suffering, punitive damages, legal costs, and more. Here at our law firm, our team is fully committed to helping our clients recover the maximum payout available for their claims. Whether our experts have to negotiate a settlement or take your claim to trial, you can trust that our team is ready to go above it all to secure the highest recovery possible.

Yes – you could have a claim that could form a part of a class action or mass torts. These claims deal with patients who have suffered injuries associated with a defective spinal cord stimulator. If you would like to learn more about your right to participate in a class action claim or mass torts claim, contact us today.

Unfortunately, defective medical devices continue to be a major problem. Here at our law firm, our defective spinal cord stimulator lawsuit lawyers are more than ready to take care of your claim and provide you with the guidance that you need to file your lawsuit and fight for your right to justice. We are not afraid to take on any manufacturer or any other entity.

We are proud to offer free case reviews, which include free consultations and free second opinions. During these free legal services, our team will be available to answer all your questions, address all your concerns, and provide you with all the information that you need to begin or continue your defective medical device lawsuit. If you are ready to schedule a free case evaluation, contact us today.

Zero-Fee Guarantee: our clients will not be required to pay any upfront legal costs for any legal services. In addition, our law firm works on a strict contingency structure, so our clients will actually not be responsible for paying anything if they do not win their claims. If you do not win, you simply will not pay anything.

Contact us today to learn more about your right to file a lawsuit for damages resulting from a defective spinal cord stimulator.

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