On July 31, 2012, St. Jude Medical announced a recall of some of its Eon and Eon Mini pain management implants. The company had received hundreds of reports that the devices were failing prematurely, sometimes resulting in first- or second-degree burns in patients.
The company issued a “Dear Doctor” letter on July 26, 2012, reporting that over 200 people had complained of problems related to the Eon Mini implantable pulse generator (IPG). This letter served as an update to an earlier letter dated May 24, 2011, in which St. Jude announced an Eon Mini recall of several models found to be potentially defective.
What is the Eon Mini?
About the size of a watch, the Eon Mini is a neurostimulator that is implanted along the spinal cord to help reduce chronic pain and symptoms of other conditions like dystonia and Parkinson’s disease. The device generates electrical impulses that travel through “leads” to the spinal cord or brain, where they can either block pain messages or help control muscle spasms and tremors.
The device is placed under the skin and then connected to the area of the body that needs the electro-stimulation. St. Jude initially marketed the device as FDA-approved to last at least 10 years, but plaintiffs in Eon Mini lawsuits often complain of premature failure, as early as six months after implementation.
Dangers of the Eon Mini
The Eon Mini has a history of reported defects that have led the device to not only malfunction, but in some cases, to cause serious injury to patients. In May 2011, the company implemented an Eon Mini IPG recall of certain models that carried a risk of being defective. According to a Dear Doctor letter sent out on that date, the company had received 78 reports of problems with the device, including a lost ability to communicate or recharge.
In the July 2012 “Dear Doctor” letter, the company revealed that the number of adverse event reports had increased to over 200. The company stated again that the products had lost the ability to communicate or recharge due to the development of a crack in the inner battery weld.
That same year, there were an additional over 300 reports of the devices overheating, with three individuals suffering first- and second-degree skin surface burns. A total of 72 had to have the devices removed.
St. Jude Eon Mini Lawsuit
St. Jude issued a later update stating they had implemented design improvements to address the problems. Patients who suffered injuries as a result of the defects, however, may still be able to recover damages in a St. Jude Eon Mini lawsuit.
Exclusively focused on representing plaintiffs, especially in mass tort litigation, Eric Chaffin prides himself on providing unsurpassed professional legal services in pursuit of the specific goals of his clients and their families. Both his work and his cases have been featured in the national press, including on ABC’s Good Morning America.