In May 2010, the FDA issued a Class 2 recall for the Eon Mini Implantable Pulse Generator (IPG). This was due to the device not charging properly.
St. Jude Medical followed with a “Dear Physician” letter recalling devices manufactured before September 2010. St. Jude also issued an Eon Mini recall in May 2011 due to devices being defective. Doctors were told to return unused devices and continue to follow-up with patients who were implanted with the Eon Mini.
Another “Dear Physician” letter was issued by St. Jude in December 2011. At this time St. Jude said patients were experiencing an “uncomfortable temperature increase” when the device was charging.
In July 2012, the FDA issued a Class 2 recall for the Eon Mini Neurostimulation (IPG) system. This was due to the loss of battery life, which led to the loss of pain relief for patients.
Then, in August the FDA issued a Class 2 recall for the Eon Mini citing 110 complaints from patients who experienced heating or warming at the implant site.
Another Class 2 recall was issued in August 2013. St. Jude Medical received over 200 reports that had an inner battery issue.
What is the Eon Mini?
The Eon Mini Neurostimulation implantable pulse generator (IPG) helps patients suffering from chronic leg or lower back pain.
The FDA approved the device in April 2008. St. Jude said the device had the longest battery life when compared to other spinal cord stimulation (SCS) devices. Spinal cord stimulation is a form of neuromodulation. Neuromodulation helps patients with movement disorders and chronic pain due to several conditions including:
- Primary dystonia
- Essential tremor
- Intractable angina pectoris (AP)
- Chronic back, leg pain associated with (FBSS)
- Complex Regional Pain Syndrome (CRPS)
- Parkinson’s Disease
The device was implanted in the first patient in September 2008.
Eon Mini Lawsuit
If your surgeon implanted an Eon Mini device and then you experienced serious complications you may be eligible for an Eon Mini lawsuit.
Some patients have complained the Eon Mini burned their skin, that they had reduced pain relief and symptoms they had before surgery.
Eon Mini Lawyer
Unfortunately, we are no longer investigating these cases.