August 3, 2012 — The Minnesota-based medical device company St. Jude Medical has updated a recall on the Eon and Eon Mini pain management system. There is a problem with a weld on some of the batteries, which can cause the devices to fail or overheat. Hundreds of people have required surgery to remove the defective implant. Three people suffered 1st or 2nd-degree skin burns due to overheating batteries.
The problem is that defective welds on the batteries can crack. Because the battery is hermetically sealed, there is no risk that the contents of the battery will leak into the patient’s body. However, the battery may be unable to hold a charge, and will not be able to provide pain management. Therefore, people with a defective device will require an additional surgery to replace the battery.
On June 26, 2012, St. Jude published an update to the previous Eon and Eon Mini recalls from May and December 2011. They warned that they had received reports for 214 cases where the battery failed prematurely and the person required corrective surgery. Because nearly 35,000 people have been implanted with the devices, the failure rate appears to be low — about 0.62%. The company has also received reports of 72 cases where the battery overheated, and three people suffered burns. St. Jude noted that the reports were voluntarily submitted, and may under-estimate the actual number of defective devices.
One woman has already filed a lawsuit against St. Jude. The battery in her Eon device failed after only six months, and she required surgery. As with any planned surgery, there is a risk of infection, pain, complications of anesthesia, and debilitation while the patient recovers.
St. Jude has traced the defect to a manufacturer who supplies the batteries. The company has identified a need to test, maintain, and replace equipment that involved in the alignment of welds on the batteries. The issues are being addressed, and St. Jude has increased surveillance of batteries in its other products. So far only certain models of the Eon and Eon Mini are involved in the recall.