The Eon Mini Neurostimulator was recalled after being linked to electronic surges that caused patients to experience intense pain. Our firm works with experienced defective medical device attorneys across the country, who charge no legal fees until you receive a settlement or award. Feel free to call us toll free or fill out a contact form for a free (no obligation) case evaluation.
What is the Eon Mini Neurostimulator?
The Eon Mini Neurostimulator is an implantable pulse generator (IPG), typically implanted into a patient’s spinal area to deliver electronic pulses that serve to alleviate patients’ pain. The device is manufactured by St. Jude Medical, Inc. and was implanted in over 34,000 patients to manage their chronic pain.
Among the patients who have been implanted with this device, some have found that it causes pain instead of alleviating it. A number of alleged problems have been reported, including: problems with persistent and increasing electrical shocks, burns from the device overheating, and problems with the device’s battery pack. For patients who experienced these problems, the device ultimately failed.
Where a defective medical device has been implanted in a patient and fails, additional surgery is usually necessary to remove the device as a corrective measure. The additional surgery is not only costly, but it also threatens patient health.
FDA Warnings Regarding the Eon Mini Neurostimulator
The FDA initially approved the Eon Mini Neurostimulator without mandating that St. Jude submit clinical data regarding the device. Evidence later revealed that St. Jude failed to conduct any clinical testing to determine how the device would operate in a human body.
After obtaining FDA approval, St. Jude placed this product into the market and began to promote and sell it. Over 30,000 patients had this device implanted in at a doctor’s direction to stimulate and relieve chronic pains. Many patients have reported experiencing sudden sharp pains from the electronic stimulation of the device, while others have overheated, and some devices have failed altogether.
In July of 2012, St. Jude notified physicians by letter that there were problems with the device’s battery pack, including cracks in the welding that may have been caused by moisture. In that some month, the manufacturer notified patients that it had received adverse vent reports of the device overheating as the battery was recharging. Hundreds of patients had complained of warmth of heating at the site where their device had been implanted, in severe cases, causing patients to suffer first- and second-degree burns. St. Jude Medical had previously notified physicians of this problem back in December 2011. Eventually, in October 2012, the FDA announced a recall of this product.
Defective Medical Device Lawsuits
In defective medical device lawsuits, the device manufacturers had a legal duty to make sure that the devices they put on the market are safe and effective when used as directed. As such, manufacturers are generally expected to comply with proper clinical trial and testing guidelines for a device before placing it on the market. The responsibility does not end there however, as manufacturers should continue monitoring and/or adjusting the device’s performance to improve its effectiveness for patients.
Contact the Law Offices of d’Oliveira & Associates
If you or a loved one has been harmed by the Eon Mini Neurostimulator device after having it implanted at a doctor’s direction, you may be entitled to compensation for your injuries, other losses, as well as pain and suffering. The injury and disability attorneys at d’Oliveira & Associates are working with dangerous medical device lawyer nationwide, who have the experience to help you pursue your case.