Spinal Cord Stimulator Malfunction

The Silent Failure: When Your Spinal Cord Stimulator Turns on You

Imagine the hope. The promise of relief. You’ve battled chronic pain for years. Then, a doctor suggests a spinal cord stimulator (SCS). It’s supposed to be a game-changer. An implant that quiets the relentless agony. You go through the surgery, the recovery, all banking on a better life. Only, for far too many, that hope shatters. The device malfunctions. The pain comes screaming back, sometimes worse than before. Or, it delivers agonizing shocks. It can be a nightmare. A betrayal.

We’ve seen it happen. Over 107,000 times in just four years, between July 2016 and July 2020. That's how many adverse event reports the FDA received concerning these devices. Think about that number. One hundred seven thousand. Those reports include 497 associated with patient deaths, nearly 78,000 involving serious injuries, and close to 30,000 device malfunctions. This isn't just a statistic to us. It's a person. A family. A life turned upside down. And frankly, it makes me angry.

What Exactly Is a Spinal Cord Stimulator (SCS)?

A Spinal Cord Stimulator is a medical device. It’s surgically placed under your skin, usually in the abdomen or buttock. Small wires, called leads, run from it to the epidural space near your spinal cord. The device sends mild electrical pulses through these leads. The goal? To interrupt or mask pain signals before they reach your brain. It's meant for people with chronic pain who haven't found relief from other treatments. Sounds good on paper, right?

When Relief Turns to Ruin: Common SCS Malfunctions

When an SCS works, it can be a miracle. But when it doesn't, the consequences are devastating. My firm has handled countless cases where these devices, meant to heal, have caused more harm. We know the common culprits:

• Lead Migration: This is a big one. The leads, those tiny wires, can move from their initial placement. They shift. This means the stimulation either stops working or goes to the wrong spot, causing new, sometimes excruciating, pain or even shocking sensations. It's the most common device-related complication.
• Lead Fracture or Breakage: The wires themselves can break. Imagine a tiny electrical wire inside your body, snapped. No more pain relief. Sometimes, it causes intermittent, painful jolts.
• Battery Failure: The power source dies. Not just slowly, sometimes suddenly. The device becomes useless, and you need another surgery just to swap it out.
• Infection: Any implanted device carries this risk. An infection at the implant site can be severe, leading to high fever, terrible pain, and often, the complete removal of the device.
• Hardware Malfunction: The device itself just stops working as it should. A component fails. It's a lemon.
• Programming Errors or Inadequate Relief: Sometimes, the device simply doesn't deliver the promised pain relief, even if technically working. Or, it's programmed incorrectly, leading to new or worsened symptoms. The FDA reported that over 30,000 complaints cited unsatisfactory pain relief.
• Neurological Injury: In rare but horrific cases, the implantation itself, or a malfunction, can cause direct trauma to the nervous system, leading to new motor or sensory changes.

The Regulatory Loophole and Corporate Greed

This isn't always about a doctor's mistake. Often, it's about the device itself. About how it was designed. How it was approved. And here's where my professional passion truly ignites.

Major manufacturers like Abbott and Boston Scientific, among others, have been accused of using a regulatory shortcut. They allegedly made significant design changes to their devices, introducing what were effectively new products. But instead of going through the rigorous, independent clinical testing required for entirely new Class III medical devices, they used "Premarket Approval (PMA) supplements." This sidestepped the intense scrutiny. It allowed them to bring potentially untested, unsafe devices to market faster. Faster, and with less cost. While patients were left to bear the risks.

Lawsuits against these companies are piling up. They allege defective design, a failure to warn patients and doctors about known risks, and a shocking misrepresentation of device safety. There's even a motion to consolidate many of these federal lawsuits into a multidistrict litigation (MDL). That tells you the scale of the problem.

Your Rights When a Device Fails

If your spinal cord stimulator malfunctions, you have rights. Serious rights. You might have a product liability claim against the manufacturer. This means we investigate if the device was defectively designed, defectively manufactured, or if the company failed to adequately warn you or your doctor about its dangers. In some situations, there might also be a claim for medical negligence if your doctor made an error in implantation or management. These are complex cases. They demand a firm with experience fighting powerful medical device corporations.

Beyond the Medical Bills: Understanding Your Claim's Value

A malfunctioning SCS doesn't just mean more medical bills. It means agonizing pain. More surgeries. Lost income because you can't work. The emotional toll of shattered hope. We calculate all of it. Your claim isn't just about hospital costs. It's about:

• Pain and Suffering: The physical and emotional anguish you endured.
• Lost Wages: Income you couldn't earn due to injury or recovery.
• Future Medical Costs: The expense of revision surgeries, removal, and ongoing treatment.
• Diminished Quality of Life: How this failure impacts your daily activities, hobbies, and overall well-being.

Whether it leads to a settlement or a verdict after trial, our goal is to get you full and fair compensation. These corporations need to be held accountable for putting profits over people.

Immediate Steps to Take if Your SCS Malfunctions

Time is often critical. Don't delay. Here's what you need to do:

• Contact Your Doctor/Surgeon Immediately: Report all new or worsening symptoms.
• Document Everything: Keep a detailed log of your pain, symptoms, medication, and how the malfunction affects your daily life.
• Gather Medical Records: Collect all records related to your SCS implantation, follow-up, and any issues.
• Do NOT Sign Anything: The manufacturer might try to contact you. Do not sign any releases or statements without speaking to a lawyer first. You could give away your rights.
• Contact a Qualified Personal Injury Lawyer: Find someone with specific experience in medical device product liability. This is crucial.

People Also Ask:

How often do spinal cord stimulators malfunction?

The rates are alarmingly high. Between July 2016 and July 2020, almost 30,000 device malfunctions were reported to the FDA. Overall complication rates can be as high as 20-40%. Studies even show that about one in four patients will need another surgery to fix hardware problems, often within three years of the initial implant.

What are the signs a spinal cord stimulator is failing?

Watch for a return of your original pain, or even new pain. You might feel painful electrical shocks, burning sensations, or a complete loss of stimulation. Battery alerts or a device that simply stops responding are also clear signs. If your pain relief diminishes, or your symptoms change unexpectedly, get it checked out.

Can I sue if my SCS device fails?

Absolutely, yes. If your spinal cord stimulator malfunctions and causes you harm, you generally have grounds for a product liability lawsuit against the manufacturer. This might be due to a defect in the design, a manufacturing error, or insufficient warnings about the device's risks. We've seen many such cases. It's about holding them accountable.

Fact Check / Disclaimer:

The information provided in this blog post is for general informational purposes only and does not constitute legal advice. Every case is unique, and past results do not guarantee future outcomes. The statistics cited are based on publicly available data from the FDA and other research bodies at the time of writing. If you believe your spinal cord stimulator has malfunctioned, you should consult with a qualified medical professional and an experienced personal injury attorney to discuss your specific situation. This firm is dedicated to seeking justice for those harmed by defective medical devices. For more information on medical device litigation, please visit our firm's medical device litigation page.