The Eon Mini Neurostimulator is an “implantable pulse generator” (IPG) device manufactured by St. Jude Medical, Inc.. The device was recalled by the Food and Drug Administration in October 2012. However, prior to that recall, it had been implanted in more than 34,000 patients to assist them with chronic pain management.
Problems with St. Jude’s Eon Mini Neurostimulator
The Eon Mini Neurostimulator was inplanted in patients 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 FDA approved the Eon Mini implantable pulse generator (IPG) without requiring St. Jude to submit clinical data, is later became evident that St. Jude failed to conduct any clinical testing to determine how the device would operate in the human body.
Many patients who had the device implanted have complained of painful jolts of electronic stimulation from the Eon Mini IPG. Others have reported instances of the device overheating. Many of these device eventually failed, forcing patients to undergo additional surgery to remove the device.
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 company 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.
Manufacturers like St. Jude Medical have a duty to ensure devices they put on the market are safe and effective when used as directed. However, St. Jude failed to meet this duty, resulting in injury to hundred of patients.
Contact An Experienced Neurostimulator Attorney
If you or loved one has been injured through the of the use of an Eon Mini Neurostimulator, you should be aware of your potential right to compensation. The lawyers at Kelley Bernheim Dolinsky, LLC offer free and confidential evaluations for those who feel they have been injured through the use of these products.