FDAFDA · Food and drugs·Recall number Z-2281-2012
The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with 4, 8, and 16 electrode leads. Product Usage: The Eon and Eon Mini Neurostimulation Systems are 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.
Published September 5, 2012 · Recall initiated: December 19, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
As of 11/30/2011, St. Jude Medical has received 110 patient complaints of warmth or heating at the implantable pulse generators (IPGs) implant site during charging for the Eon IPG and 116 reports of similar symptoms for the Eon Mini IPG, respectively.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Advanced Neuromodulation Systems Inc.
- Distributor
- Nationwide within the US, and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Isreal, Italy, Japan, Mexico, Netherlands, Puerto Rico, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
- Lot
- All lots of Eon Mini (Product Code 65-3788)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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