Helpful Information
Bringing a spinal cord stimulator claim
If you have experienced injury and losses after the implantation of a spinal cord stimulator, there are several situations where you may have a solid foundation for a compensation claim. This includes the following:
- The device has manufacturing defects – If the spinal cord stimulator was improperly manufactured, leading to a defect that caused injury, the manufacturer can be held liable. This could include issues like faulty wiring, contamination during production, or improper assembly.
- The device has design defects – If the spinal cord stimulator’s design is inherently unsafe, even when manufactured correctly, an injury claim can be made. For instance, if the design causes the device to malfunction under normal use, leading to injury, the designer and manufacturer could be liable.
- There were inadequate instructions or warnings – If the manufacturer or distributor failed to provide adequate warnings or instructions regarding the potential risks of using the spinal cord stimulator, and this omission led to injury, you might have grounds for a claim. This could include failing to warn about possible complications, side effects, or proper usage instructions.
- Negligence on the part of the healthcare provider responsible for fitting the device – If a healthcare provider was negligent in selecting, implanting, or monitoring the spinal cord stimulator, leading to injury, a medical malpractice claim could be filed. This type of claim would be against the medical professional or healthcare institution rather than the manufacturer.
To prove your case, you must show that the device manufacturer or healthcare provider owed you a duty of care, breached that duty through actions or omissions, and directly caused harm. Essential evidence includes medical records, expert testimony, and documentation of the injury’s impact to establish this breach and the link to your harm. Demonstrating negligence involves clearly connecting the provider’s actions to your adverse outcomes.
Our highly experienced legal team here at McCarthy + Co Solicitors LLP can help you gather evidence and build a strong case to hold those responsible accountable. Arrange a time to speak with a solicitor by completing our confidential online form.
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Meet John McCarthy
John McCarthy is a partner at McCarthy + Co Solicitors LLP, with more than 20 years of experience in medical negligence and product liability claims. He has represented clients in high-value cases at the High Court and Supreme Court levels.
John holds a diploma in civil litigation from the Law Society of Ireland and is a member of Action Against Medical Accidents (AvMA), the leading patient safety charity. He is also the author of A Patient’s Guide to Bringing a Claim for Medical Negligence. If you have suffered as a result of a defective spinal cord stimulator, you can contact John directly at john@mccarthy.ie.
Frequently Asked Questions
Some of the questions often posed to our medical negligence team.
Which spinal cord stimulators have been known to fail?
Brands of spinal cord stimulators known to have failed include Medtronic and Boston Scientific. Defects with these and other brands have led to multiple lawsuits, with a recent analysis showing that over 80,000 people in the USA alone sustained injuries due to these devices. Claimants have alleged that these defects caused significant harm, including nerve damage, increased pain, or other severe complications.
What laws govern these devices?
The use of spinal cord stimulators is governed by EU medical device regulations, primarily the Medical Devices Regulation (MDR) 2017/745, which applies across the EU. This regulation sets standards for the safety, performance, and quality of medical devices. Additionally, the Health Products Regulatory Authority (HPRA) oversees the regulation and monitoring of medical devices in Ireland. The Health and Safety at Work Act 2005 may also apply if negligence in the workplace contributes to harm.
What harmful effects warrant a claim?
If you have suffered any pain or injury following the implant of this type of device, you may have the basis to bring a claim. Defective spinal cord stimulators can cause a range of harmful effects, including burning sensations, electric shocks, and lead wire fracture or migration. These issues may lead to urinary incontinence or retention, gastroparesis, dysphagia, and faecal incontinence. Cognitive complications like dizziness or fainting, ineffective or worsening pain, and cardiac arrhythmia are also possible. These adverse effects can significantly impact quality of life, often requiring further medical intervention, and can lead to additional health complications, including potential long-term damage. In cases where you have sustained serious long-term health problems, you may be entitled to a substantial general damages pay award, together with special damages to cover your bills and out of pocket expenses.
Is it necessary to consult a solicitor?
Consulting a solicitor is essential if you have been fitted with a defective spinal cord stimulator. A solicitor with expertise in defective medical device claims can provide expert legal advice, assess the strength of your case, and guide you through the complex legal process. They help gather crucial evidence, such as medical records and expert testimony, to prove negligence and link it to your injuries. Your solicitor will also handle negotiations with manufacturers or healthcare providers and represent you in court if necessary. Their expertise increases your chances of obtaining fair compensation for your injuries, medical expenses, and any other related losses.
Useful resources
Some links relating to this topic that you may find useful.
- Becker’s Spine Review – Abbott Medical Recalling Proclaim Spinal Cord Stimulators
- TGA – Medtronic spinal cord stimulation device risks
- John Hopkins Medicine – What is a spinal cord stimulator and how does it work?
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