August 3, 2012 — St. Jude Medical has announced a recall of its Eon and Eon Mini implants. Hundreds of the implanted devices had to be removed when the batteries failed prematurely. Some batteries also overheated while recharging, and 3 people suffered 1st or 2nd-degree burns on their skin.
St. Jude ordered the recall after 214 people had to have the Eon Mini removed after the battery failed prematurely. There are approximately 35,000 total implanted devices, so the failure rate is relatively low (0.62%). The company also received reports from 72 people whose Eon batteries overheated while recharging.
This is not the first time St. Jude has recalled the Eon and Eon Mini. There were other warnings in May and December 2011.
The company is already facing a defective St. Jude Eon lawsuit from a woman who had to have surgery to remove the device. The battery in her device failed after only six months. The promotional materials for the Eon claim the device has a “market-leading battery capacity and the longest time between recharges.”
Unfortunately, welds can crack on the battery for the Eon Mini model 3788. This does not cause the battery to leak because it is in a sealed case, but the broken device will be unable to provide pain relief. Therefore, patients will need to have additional surgery to have the defective implant removed.
The company blames the defect on faulty equipment at a supplier. They identified the need to maintain and replace tools to ensure complete alignment of the welding apparatus and the battery. The company has taken steps to address the problem with the supplier. They have also ramped up testing of batteries in other products to check for the same defect.
The company warns that explant surgery can pose health risks to patients. As with any surgery, there is a risk of infection, scarring, pain, complications of anesthesia, and debilitation during recovery time.