St. Jude Medical recalls Eon | 合法醫療器材資訊網
2012年7月31日—St.JudeMedical'sEonandEonMinipainmanagementimplants...rechargeableneurostimulationsystems–theEon,EonMiniandBrio...Ifthatdoesn'twork,"pleasecontactyourSJMrepresentativeforevaluation,"hewrote
St. Jude Medical[1] (NYSE:STJ[2]) 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.
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User's Guide | 合法醫療器材資訊網
Prodigy™ Neurostimulation System Programming and ... | 合法醫療器材資訊網
MRI Procedure Information | 合法醫療器材資訊網
Results for Family Implantable Pulse Generators (IPGs) | 合法醫療器材資訊網
“SJM” Eon Neurostimulation System – 合法醫療器材資訊網 | 合法醫療器材資訊網
THE List | 合法醫療器材資訊網
St. Jude Medical recalls Eon | 合法醫療器材資訊網
MRI Support | 合法醫療器材資訊網
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