Spinal Cord Stimulator Lawsuits: Device Failures, FDA Recalls, and Who May Qualify for Compensation

Spinal cord stimulators may not be nearly as safe as manufacturers let on.

Between 2000 and 2022, more than 80,000 injuries involving stimulators were reported to the federal Food and Drug Administration, with more recent estimates placing this figure even higher. Of all the medical devices currently on the market, stimulators have the third-highest rate of “adverse events,” a designation that includes documented incidences of serious injury, disability, and even death.

Here is what you need to know about:

Spinal Cord Stimulators

Spinal cord stimulators are used to relieve severe and chronic pain.

The science behind stimulators is complex, but the guiding principle is relatively simple. The sensation of pain, for instance, has a physical origin. Pain is your body’s reaction to specific electrical signals sent between the nervous system, the spinal cord, and the brain. Once received by the brain, these currents are translated into a distinctively unpleasant sensation pain, your body’s way of letting you know that something is seriously wrong.

Stimulators help relieve pain by hijacking the physiological mechanism that drives it. Most stimulators are comprised of two basic components: a bundle of wires inserted into the spinal canal, and a Pacemaker-like battery device implanted into the buttocks or flank. Using a remote control, patients can send electrical signals up and down the spinal cord, reducing the brain’s ability to distinguish genuine pain signals from the current introduced by the stimulator.

Spinal cord stimulators are today used to treat conditions ranging from angina to chronic back pain, diabetes-related neuropathy, phantom limb syndrome, and automobile accident-related spinal cord injuries.

The Medical Device Industry’s CSC “Shortcut”

The U.S. Food and Drug Administration categorizes stimulators as a “Class III” device.

A Class III device is any medical device that poses a high risk to patients’ safety and well-being. In order for a Class III device to be sold on the open market, it must typically undergo a rigorous series of clinical trials, tests, and safety reviews. The first generation of functional stimulators went through review in the early 1990s.

In the years since, many manufacturers have made significant changes to their stimulators. However, despite introducing features like Bluetooth connectivity and reprogrammable software, these devices never underwent additional safety reviews. Instead, manufacturers claimed these radical alterations were merely “Premarket Supplements,” a designation that does not require additional trials and tests.

The implication is that many of the safe and “FDA-approved” stimulators sold across the country are borderline-unrecognizable variants of older devices with obsolete architectures. Nobody understands their dangers because the new designs were never subjected to the same rigorous testing as their predecessors.

Your Rights After A Stimulator Injury

You should not have to pay the price for a multibillion-dollar company’s shortcut.

Modern spinal cord stimulators are associated with a wide range of complications, some of which could be life-threatening. These include:

1. Burning sensations;
2. Electrical shocks, including electrocution;
3. Post-surgical bacterial infections;
4. Internal organ and tissue damage;
5. Urinary incontinence;
6. Neurological symptoms;
7. Pain that returns after your body adjusts to the stimulator;
8. Pain that grows worse over time;
9. Disfigurement; and
10. Death.

You could be entitled to file a product liability lawsuit against Abbott, Boston Scientific, Medtronic, Nevro, or another medical device manufacturer if you have suffered serious injuries due to a defective stimulator. Call Jed Dietrich, Esq., today at 1-716-839-3939 to speak to a CSC injury lawyer in Buffalo and schedule your 100% free, no-obligation consultation as soon as possible.

Call the Dietrich Law Firm P.C. immediately at 1-716-839-3939 so that our aggressive, tenacious, and hardworking personal injury lawyers can fight to obtain the best result for your personal injury claim in Buffalo, New York. We are available 24 hours a day, 7 days a week, and there is never a fee until we WIN for you!