The Eon Mini is a pacemaker-like device that delivers mild electrical pulses to the occipital nerves, located at the back of the head, to help migraine patients who aren’t well managed by drugs.
In clinical trials, the data from which has yet to be published, patients reported an average of 6 fewer migraine days per month after 12 weeks of treatment with the peripheral nerve stimulation. After 1 year 65% of patients reported "excellent" or "good" pain relief, and nearly 90% said they would recommend the procedure to someone else.
St. Jude touts the Eon implants as having "market-leading battery capacity and the longest time between recharges" and claims the Eon Mini as "FDA-approved to operate at least 24 hours between recharges at 10 years at high settings," saying that’s "the longest battery life approval in the market and the only approval that provides a statement of time between recharges."
In May and December of 2011 the medical device titan updated a recall of some lots of the Eon and Eon Mini devices after receiving
100s of reports that the devices had to be taken out after their batteries failed early or because they overheated during recharging – including 3 cases in which patients received 1st- or 2nd-degree burns.
St. Jude issued new updates over the summer, by which time the company had received 214 reports that its Eon Mini model 3788 implantable pulse generators "lost the ability to communicate or recharge," due to cracked welds in the batteries, "resulting in loss of pain relief and subsequent explant."
An internal investigation concluded that cracks were related to issues in the battery manufacturing process at a St. Jude Medical supplier, the company announced in July.
St. Jude said it’s taken steps to correct the problem with its battery supplier, including "extensive testing of samples of batteries contained in IPGs in products beyond this recalled population" showing that the battery issue has been "mitigated."