What Are the Eon and Eon Mini Implantable Pulse Generators?
St. Jude Medical’s Eon and Eon Mini implantable pulse generators (IPGs) are battery-powered medical devices that are surgically implanted to treat neurological disorders and pain. The miniature medical device is surgically placed near the spine. The device works by delivering an electrical pulse to the brain, nerves, or spinal cord. The nerve stimulation helps to control severe pain. The device uses a battery that is recharged every 24 hours. It must be replaced when the battery runs out, about every ten years.
St. Jude Recalls Eon and Eon Mini Implantable Pulse Generators
On July 26, 2012, St. Jude alerted physicians that the batteries in the Eon and Eon Mini could fail and overheat during charging, causing serious burns. The FDA recalled 70,638 IPG devices after two reports of first-degree burns and one report of second-degree burns in patients implanted with the medical device. St. Jude also received 127 patient complaints of heating during charging for the St. Jude Eon IPG and 198 complaints of heating during charging for the Eon Mini IPG. In some cases, there was enough heat to cause discomfort, pain, and injury. Patients also complained that the IPGs would not recharge, did not fully charge, or would suddenly lose power, resulting in a loss of pain relief.
St. Jude warned that patients who experience warmth or heating while the Eon or Eon mini IPG is charging may be at risk of serious burns that could cause pain, scarring, and other complications. The medical device manufacturer recommended that any device that overheats should be surgically removed.
St. Jude claims that the company is working with the battery supplier to correct the problem. Any un-implanted devices should be returned to St. Jude for a free replacement. Patients who have implanted devices should be monitored for signs of battery failure including:
- Warmth at the implant site
- Heat at the implant site
- Redness or swelling at the implant site
- Burns
This Is Not St. Jude’s first recall
This is not the first time that a defect in a St. Jude medical device has caused injury to patients. The St. Jude Riata and Riata ST defibrillator leads were recalled because the electric wires could work through the insulation, causing injury.
Know Your rights
Patients who have experienced warmth, heating, or burning sensations associated with the Eon or Eon Mini spinal cord stimulators may be eligible for compensation for the cost of surgery, a new IPG implant, and related medical expenses. You may also qualify for compensation for your lost wages and other expenses. To learn more, contact a Salt Lake City defective medical device attorney.
The James Esparza Law Firm is currently investigating patient injuries caused by the Eon and Eon Mini IPGs. Contact our office at 800-745-4050 to learn if you have a case.