The Eon Mini Neurostimulation implantable pulse generator (IPG) is used to help patients suffering from chronic leg or lower back pain. In April 2008, the FDA approved the device, and it was implanted in more than 34,000 patients. St Jude Medical Inc., the manufacturer of the Eon Mini, was not required to submit clinical data. They also did not conduct clinical testing to determine how the device would operate in an environment similar to the human body. In October 2012, the FDA announced a recall of the Eon Mini Neurostimulation IPG. Hundreds of patients complained of the device overheating, causing pain instead of relief and resulting in either a device revision and/or replacement surgery.
In July 2012, St. Jude Medical admitted that the IPG’s internal battery has potential to come in contact with the internal microcontroller board. They received 300 complaints of warmth, as well as overheating causing first and second degree burns in a few patients. Additionally St. Jude identified a weld crack in the IPG’s inner battery caused by moisture. Without the proper clinical trials and testing, St Jude Medical put patients at risk and caused undo pain. To St. Jude’s credit, they did alert physicians of the issues in December 2011.
It is unnerving that the devices were implanted even with the warning signs, and the FDA did not recall it until October of 2012, after hundreds of patients suffered.
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