St. Jude Medical is recalling some of its Eon and Eon Mini pain management implants 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 Medical (NYSE:STJ) advised doctors and patients last week that it's recalling some of its Eon and Eon Mini pain management implants after hundreds of the neurostimulation devices had to be taken out when their batteries failed too soon or because they overheated while recharging.
The July 26 letters detail problems with St. Jude Medical's Eon Mini battery welds that led to 214 explantations out of nearly 35,000 implanted devices (that's about 0.06%). They also explain 325 reports that the Eon Mini and Eon devices overheated during re-charging, with a total of 72 resulting explants and 3 cases in which patients received 1st- or 2nd-degree skin surface burns.
A St. Jude spokeswoman told MassDevice.com in an email that the latest recall notices are updates of prior warnings from May and December of last year.