Eon Mini Recall Lawsuit
What is the Eon Mini?
The Eon Mini Neurostimulation implantable pulse generator (IPG) helps patients who suffer from chronic lower back or leg pain. The St. Jude Medical Eon Mini is a 16-channel device generates electrical impulses that travel through the body to the brain, spinal cord or nerves.
According to a news release sent out by St. Jude Medical, the Eon Mini was approved by the FDA in April 2008. St. Jude said the device had the longest battery life of any “rechargeable spinal cord stimulation, (SCS) device in its class.”
Spinal cord stimulation is a form of neuromodulation, where nervous tissues on the spinal cord are stimulated electronically to block pain signals to the brain.
Patients with the following conditions can benefit from neuromodulation:
- Primary dystonia
- Peripheral vascular damage
- Intractable angina pectoris
- Chronic pain of the trunk and limbs
- Parkinson’s disease
In September 2008, St. Jude Medical announced the first person who was implanted with the Eon Mini neurostimulator. According to the release, Adam Hammond, a former member of the U.S. Army “Golden Knights” Parachute Team was skydiving while on leave and his parachute didn’t deploy properly. He hit the ground and suffered several injuries.
As of 2008, St. Jude Medical reported more than 45,000 patients were implanted with the device around the world.
Eon Mini Recall
In May 2010, the FDA issued a Class 2 recall for the Eon Mini Implantable Pulse Generator (IPG). The FDA states the device may gradually or suddenly lose its charging capacity.
In September 2010, St. Jude Medical said they clarified the spacing of the battery component to correct the issue. Devices manufactured before that time were recalled.
The following year, in December 2011, St. Jude Medical issued a “Dear Physician” letter informing doctors that they received over 100 complaints pertaining to the Eon Mini (IPG). They received reports of “temperature elevations” when the battery was charging.
Then, the FDA issued a Class 2 recall for the Eon Mini Neurostimulation (IPG) system in July 2012. This was also due to loss of battery life, leading to the loss of pain relief.
That same month, another “Dear Physician” letter was issued by St. Jude Medical pertaining to “inner battery cracking issues” in the Eon Mini model 3788 (IPG).
In August, the FDA issued a Class 2 recall for the Eon Mini citing 110 complaints from patients who were experiencing “warming or heating” at the implant site.
In August 2013, the FDA issued another Class 2 recall. This recall came after St. Jude received over 200 reports of inner battery issues with the device.
Eon Mini Lawsuit
Patients who were implanted with a St. Jude Medical Eon Mini and experienced pain or difficulty with the device may be eligible to file a lawsuit.
There have been reports of people experiencing burns on their skin due to the Eon Mini overheating while recharging. You may need to have the device removed immediately. If you do, the FDA warns of adverse effects from explant surgeries which could lead to scarring, pain, and infection.
Eon Mini Lawyer
Unfortunately, we are no longer investigating these cases.