FDA-Device2013-07-24Class II
Eon Mini - 3721 (Charger). Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
St. Jude Medical
Hazard
St. Jude Medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients were using the Charging System to charge their spinal cord stimulator. In three cases, patients received a burn to the skin (one second-degree and two first-degree burns) at the implant site. As of June 30, 2012, St. Jude Medica
Sold states
Worldwide Distribution - USA Nationwide Including Puerto Rico and countries of: Argentina, Australia, Belgium, Brazil, Canada, China, Chile, Colombia, Ireland, Israel, India, Malaysia, Mexico, Saudi Arabia, Singapore, South Africa, South Korea, Switzerland and United Kingdom.
Affected count
70,638 (combined total of the Eon and the Eon Mini systems)
Manufactured in
6901 Preston Rd, N/A, Plano, TX, United States
Products
Eon Mini - 3721 (Charger). Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1739-2013Don't want to check this manually?
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