The Eon Mini Neurostimulator is one of several “implantable pulse generator” (IPG) devices manufactured by St. Jude Medical, Inc. It was implanted in more than 34,000 patients to assist them with chronic pain. Perhaps you or someone you care about is one of these patients. The Food and Drug Administration announced a recall of this medical product in October 2012.
St. Jude’s Eon Mini Neurostimulator is the smallest of these surgically implanted devices. The devices deliver electronic pulses to the spinal cord as a means of blocking pain. But many patients implanted with the Eon Mini Neurostimulator found that the device delivered pain instead of alleviating it. Problems allegedly included persistent and increasing electrical shocks and burns caused by the device overheating. In patients experiencing these symptoms, the device eventually failed.
When a faulty or failed medical device has been surgically implanted, the typical course of action is additional surgery to remove the device. This additional pain, expense and threat to their health – no surgery is risk-free – is what patients who have received the Eon Mini Neurostimulator face.
The medical device injury lawyers at Bubalo Goode are assisting patients who are dealing with a faulty Eon Mini Neurostimulator IPG. We can review your case for free if you have this St. Jude Medical implant. We’ll advise you of your rights and legal options for seeking compensation for the expenses, and pain and suffering it has caused you.
Call Bubalo Law now at 866-870-2489 or use our online contact form to set up your free initial consultation. Our firm is representing clients throughout the country associated with other local counsel regarding St. Jude’s IPG.
The Eon Mini Neurostimulator is one of several devices designed and manufactured by St. Jude Medical to relieve chronic pain by replacing it with mild sensations, known as “paresthesia,” through spinal cord stimulation (SCS). These devices are surgically implanted and run off of rechargeable lithium ion batteries. The Eon Mini is the smallest one made.
The U.S. Food and Drug Administration (FDA) approved the Eon Mini implantable pulse generator (IPG) without requiring St. Jude to submit clinical data, and evidence later showed that St. Jude did not conduct any clinical testing to determine how the device would operate in an environment similar to that of the human body.
Yet, upon receiving FDA approval for the device, St. Jude began promoting and selling the Eon Mini Neurostimulator. Eventually, 34,617 Eon Mini IPGs were implanted in patients, according to St. Jude Medical.
Many patients have complained of sudden painful jolts of electronic stimulation from their implanted Eon Mini IPG. Others have complained of overheating. Many of these device completely failed, while causing patient excess pain.
St. Jude Medical has admitted that the IPG’s internal battery has the potential to come into contact with the internal microcontroller board. In a letter to physicians in July 2012, St. Jude said it had “identified weld cracks in the IPG’s inner battery” and that “prior analysis had indicated that moisture was the cause of weld cracking.”
In a letter to patients the same month, St. Jude said it had received reports of the device overheating as it was plugged in to recharge its batteries. More than 300 patients had complained of warmth or heating at the device implant site during charging, including one patient who suffered second-degree burns and two who suffered first-degree burns. The manufacturer had already alerted physicians to his problem in December 2011.
St. Jude Medical said it had received hundreds of reports of the Eon Mini Neurostimulator implants failing. Such a failed medical device, in most cases, must then be surgically removed.
Manufacturers like St. Jude Medical Inc. – a medical technology corporation based in St. Paul, Minnesota, which should not be confused with St. Jude Children’s Research Hospital – have a legal duty to ensure devices they put on the market are safe and effective when used as directed. This includes properly testing the device before it enters the market and continuing to monitor and/or adjust the device’s performance once it is sold to the public.
If you have been implanted with an Eon Mini Neurostimulator implantable pulse generator that has failed or caused you undue pain and injury, you may have a legal claim for compensation. The Eon Mini Neurostimulator injury attorneys of Bubalo Goode will provide a free assessment of your case and legal options.
Contact Bubalo law at 866-870-2489 for your free initial consultation today.