Abbott Spinal Cord Stimulator Lawsuit

Abbott’s spinal cord stimulator systems are used to manage chronic pain and movement disorders through low-intensity electrical impulses delivered to nerve structures.

A technical flaw has emerged related to the MRI compatibility feature, causing patients to lose therapeutic benefits and potentially requiring invasive surgical intervention to restore functionality.

MRI Mode Malfunction Mechanism

The core issue affects the Bluetooth communication pathway between the implantable pulse generator (IPG) and the Patient Controller device (a paired iPhone).

When patients activate MRI mode before undergoing magnetic resonance imaging, therapy delivery is temporarily disabled for safety reasons.

The system may become permanently locked in this disabled state under certain conditions.

According to Abbott’s investigation, this malfunction occurs when the Bluetooth pairing is compromised while in MRI mode, which can happen when:

1. Users delete the Bluetooth pairing from their devices
2. The iOS operating system or application is updated while in MRI mode
3. The Patient Controller becomes lost or disabled
4. The IPG is deleted from the list of available Bluetooth devices on the Patient Controller

Once this connection is broken while in MRI mode, the patient cannot reactivate their therapy.

Documented Injuries and Surgery Requirements

The FDA reports that Abbott has received 186 complaints about the MRI mode issue, with 73 documented injuries.

While no deaths have occurred, the consequences can be severe.

When a device becomes locked in MRI mode with no ability to restore function, patients require additional surgery to replace the entire implantable pulse generator to restore their therapy.

These surgical interventions carry their own risks, with the FDA noting that certain subpopulations, particularly those with Parkinson’s disease and movement disorders receiving Deep Brain Stimulation (DBS) treatment, face “higher morbidity and mortality with every surgery, thus otherwise unneeded anesthesia events and surgeries pose an increased hazard.”

This sudden loss of therapy can impact the quality of life and pain management for patients who rely on continuous neurostimulation interrupting pain signals.

The recall of Abbott’s neurostimulation systems has significant implications for both the company and patients affected by device malfunctions.

While Abbott has taken steps to address the technical issues, many patients are now exploring legal options to seek compensation for their injuries.

How to File a Spinal Cord Stimulator Lawsuit Against Abbott

If you or a loved one has been affected by an Abbott neurostimulator that became locked in MRI mode, you may be eligible to seek compensation.

The process for filing a lawsuit typically involves:

1. Initial Consultation: Speaking with an attorney experienced in medical device litigation to evaluate your case
2. Medical Documentation: Gathering records that confirm your Abbott device model, malfunction details, and any subsequent medical interventions
3. Statute of Limitations: Filing within your state’s timeframe requirements, which typically range from 1-3 years from discovery of injury
4. Expert Testimony: Working with medical experts who can testify about the device defect and its impact on your health

Other Manufacturers Involved in Spinal Cord Stimulator Implantation

While the current recall focuses on Abbott’s devices, it’s worth noting that other manufacturers have faced similar issues with neurostimulation technology:

• Medtronic: Has faced litigation regarding its spinal cord stimulator systems, including allegations of device migration, lead breakage, and battery failures
• Boston Scientific: Previous lawsuits have involved claims of defective leads and unexpected battery depletion in their neurostimulation systems
• Nevro Corp: Has dealt with legal challenges related to their Senza system, including allegations of inadequate warnings about potential complications
• Stimwave Technologies: Filed for bankruptcy in 2022 following lawsuits related to their wireless neurostimulator technology

If you have a neurostimulator from any manufacturer that has malfunctioned or caused injury, it’s important to consult with an attorney specializing in medical device litigation.

They can help determine whether your case relates to the Abbott recall or involves similar issues with devices from other companies.

The implantation of a spinal cord stimulator (SCS) involves a two-step process: a trial phase and, if successful, a permanent implantation.

This staged approach helps determine if spinal cord stimulation provides sufficient pain relief before committing to a permanent device.

Step 1: Spinal Cord Stimulator Trial

The spinal cord stimulator trial period begins with a minimally invasive procedure, where thin electrical leads (electrodes) are inserted into the epidural space surrounding the spinal cord.

These leads are connected to an external pulse generator worn outside the body.

Patients typically undergo local anesthesia or mild sedation for this procedure, which allows the orthopedic surgeon to position the leads precisely and test their effectiveness in real time.

The goal is to see if the device reduces pain enough to warrant a permanent implant.

The trial period typically lasts around 5-7 days, during which the patient evaluates the level of pain relief and reports any issues.

If the trial is successful, the patient may proceed to the permanent implantation phase.

Step 2: Permanent Implantation

If the patient experiences significant pain relief during the trial, a permanent spinal cord stimulator is implanted.

This process is conducted under local or general anesthesia, and the leads are implanted in the same epidural space as during the trial phase.

However, the pulse generator is now placed within the body, usually under the skin in the abdomen or buttocks.

The leads are connected to this internal pulse generator, which is programmed to provide consistent stimulation to alleviate pain.

Some devices include rechargeable batteries, requiring the patient to regularly recharge the device through an external system, while others use a non-rechargeable battery, which may need replacement surgery after several years.

Post-procedure and Device Calibration

After implantation, the device is calibrated and programmed to meet the patient’s specific pain relief needs.

Patients are trained to use a handheld remote control, allowing them to adjust the stimulation level or turn the device on and off.

Initial follow-up appointments are necessary to fine-tune the stimulator settings and ensure the device functions optimally.

Over time, as the patient’s condition or pain levels change, additional adjustments may be made to maintain effective pain relief.

Recovery and Long-Term Maintenance

Recovery from the implantation procedure can take a few weeks, during which patients are advised to limit certain physical activities to allow the device and lead to settle.

Long-term patients may require periodic adjustments, and in some cases, the device may need to be repositioned or replaced due to complications like lead migration, device malfunction, or battery depletion.

Proper maintenance and regular medical follow-up ensure that the spinal cord stimulator continues to provide effective pain relief over time.

Spinal cord stimulation as a treatment for chronic pain originated in the late 1960s when the first devices were introduced to target pain pathways directly within the nervous system.

Over the following decades, advancements in technology allowed these devices to evolve, providing greater control over pain management with more compact, reliable models.

By the 1990s, spinal cord stimulators had gained FDA approval for broader use, though their effectiveness varied significantly among patients.

Improvements in the 2000s brought rechargeable batteries, high-frequency stimulation options, and patient-controlled settings, further enhancing their appeal as an alternative to long-term pain medication.

Today, spinal cord stimulators are manufactured by multiple medical companies, each producing various models to cater to specific types of chronic pain and patient needs.

Types of Spinal Cord Stimulator Devices and Manufacturers include:

• Traditional Low-Frequency Stimulators: Manufactured by Medtronic, Abbott, Boston Scientific, and others.
• High-Frequency Stimulators: Manufactured by Nevro (HF10), Boston Scientific, and others.
• Burst Stimulation Devices: Manufactured by Abbott (BurstDR) and others.
• Rechargeable vs. Non-Rechargeable Models: Manufactured by Medtronic, Boston Scientific, Nevron, Abbott, and others.
• Fully-Implantable vs. External Power Source Options: Manufactured by Boston Scientific, Abbott, and others.

These types of spinal cord stimulators provide varied methods and technologies to address specific pain needs.

Medical malpractice claims, medical negligence claims, and product liability lawsuits have named several different types of spinal cord stimulators.

Limitations and Risks of Spinal Cord Stimulators

Spinal cord stimulators offer relief for many patients, but they come with notable limitations and risks.

For one, these devices are not universally effective; up to 30% of patients report little to no improvement in their pain levels and opt for removal, even after proper implantation and use.

Complications such as device migration, where the electrode moves from its intended position, can impact the device’s effectiveness and may require corrective spinal surgery.

There’s also a risk of infection at the implant site, which can be severe enough to warrant removal of the device.

In rare cases, patients may experience neurological side effects like numbness or even paralysis due to issues like epidural hematoma or nerve damage during insertion.

Battery life is another limitation, as the devices require battery replacement, which involves additional surgeries over time.

Spinal cord stimulators come at a significant financial cost, and insurance coverage may vary, placing a burden on some patients seeking this therapy.

Injuries from spinal cord stimulators can have a profound impact on a person’s life, often turning a hopeful treatment into a daily struggle with new and worsening pain.

For many, these complications limit their mobility, add emotional strain, and affect their ability to work or care for loved ones.

The physical and emotional toll can be overwhelming, leaving individuals to navigate medical issues and the uncertainty of their well-being in the face of ongoing pain.

If you or a loved one has suffered injuries or complications from a spinal cord stimulator, you may be entitled to seek compensation for medical expenses, pain, and the impact on your quality of life.

Contact TruLaw today for a free consultation.

Use the chat feature on this page for a free and instant case evaluation.

Gathering Evidence for Spinal Cord Stimulator Lawsuits

Building a strong case for a Spinal Cord Stimulator Lawsuit requires gathering comprehensive evidence to demonstrate the impact of the device’s failure on the patient’s life.

Medical records documenting the initial pain condition, treatment attempts, and any complications post-implantation provide critical insight into the extent of harm caused.

Expert evaluations and personal documentation of pain levels, physical limitations, and emotional distress can strengthen the case, illustrating the profound effects of the injuries.

Evidence in a Spinal Cord Stimulator Lawsuit may include:

• Medical Records: Include documentation of the original pain diagnosis, details of the spinal cord stimulator procedure, and records of any complications or subsequent treatments.
• Device Information: Collect details on the specific model of the spinal cord stimulator, manufacturer, and any recall notices or reported issues associated with the device.
• Expert Medical Opinions: Obtain statements from healthcare professionals regarding the medical implications of the device’s failure and expected outcomes.
• Pain and Symptom Diary: Keep a daily record of pain levels, limitations in activities, and emotional or psychological impacts experienced.
• Employment Records: Show documentation of work limitations, lost income, or job changes due to physical complications from the device.
• Correspondence with Manufacturers or Healthcare Providers: Save any communication related to the device, including inquiries about risks, complaints, or service requests.

Damages in Spinal Cord Stimulator Injury Claims

The damages in a Spinal Cord Stimulator injury claim aim to address both the financial and non-financial impacts of the injuries to help victims recover from the consequences of faulty devices.

These claims seek to cover not only direct costs, like medical bills, but also the broader effects on a person’s quality of life, earning capacity, and emotional well-being.

Potential damages in Spinal Cord Stimulator Lawsuits may include:

• Medical Expenses: Reimbursement for past, current, and future medical bills associated with the injuries, including surgeries, medications, physical therapy, and rehabilitation.
• Lost Wages and Earning Capacity: Compensation for income lost due to time off work and any reduction in earning ability caused by the injuries.
• Pain and Suffering: Damages for the physical pain endured from the injury, as well as emotional suffering such as anxiety, depression, or reduced enjoyment of life.
• Loss of Consortium: Compensation for the impact on relationships with family members and loved ones due to the physical and emotional effects of the injury.
• Punitive Damages: In some cases, additional damages may be awarded to punish the manufacturer for particularly egregious negligence or misconduct.
• Cost of Replacement or Removal: Compensation for costs related to replacing or removing the spinal cord stimulator if it was found to be defective or caused further harm.

If you’ve suffered severe injuries such as spinal cord injuries, severe back pain, or other complications related to a spinal cord stimulator, you may be eligible to seek compensation.

Contact TruLaw using the chat on this page to receive an instant case evaluation and determine if you qualify to join others in filing a Spinal Cord Stimulator Lawsuit today.

Our Abbott spinal cord stimulator attorney at TruLaw is dedicated to supporting clients through the process of filing a product liability lawsuit against Abbott.

With proven success in handling medical device cases, Jessica Paluch-Hoerman provides direct guidance and advocacy to clients affected by defective Abbott spinal cord stimulators, ensuring they understand their legal rights and options throughout their journey to recovery.

We recognize the physical pain and emotional strain that Abbott spinal cord stimulator complications cause, which is why we focus on streamlining the legal process of seeking the compensation you deserve.

Meet the Lead Abbott Spinal Cord Stimulator Attorney at TruLaw

Meet our lead Abbott spinal cord stimulator attorney:

• Jessica Paluch-Hoerman: With extensive experience representing clients in product liability cases, Jessica specializes in simplifying the legal process of recovering damages for medical expenses, pain and suffering, and various other forms of damages. Her dedication to holding negligent parties accountable for their actions has led to billions of dollars in compensation for her clients nationwide through verdicts and negotiated settlements.

How much does it cost to hire an Abbott Spinal Cord Stimulator lawyer from TruLaw?

At TruLaw, we believe financial concerns should never stand in the way of justice.

That’s why we operate on a contingency fee basis—with this approach, you won’t face any upfront costs for your legal representation.

Our fee is only collected if we are successful in securing compensation on your behalf.

This arrangement not only removes the financial risk of pursuing your case, it allows us to focus our resources on achieving a positive outcome in your case by:

• Court Filings and Legal Documentation: Handling all necessary paperwork, including filing fees and procedural documents, to ensure your case proceeds smoothly through the legal system.
• Research/Data Analysis: Dedicating resources to thoroughly investigate your case and gather the best possible evidence.
• Expert Testimony: Consulting with leading experts in the field to support your case and demonstrate the strength of your case to the court.
• Negotiations and Trial Preparation: Allocating resources to negotiate potential settlements and, if needed, preparing comprehensive trial strategies to present your case in court effectively.

Our investment in representing you demonstrates our unwavering commitment to seeking the compensation you deserve.

If you or a loved one experienced complications from an Abbott spinal cord stimulator device, you may be eligible to seek compensation.

Contact TruLaw using the chat on this page to receive an instant case evaluation and determine whether you qualify to join others in filing an Abbott spinal cord stimulator lawsuit today.