Enforcement Report - Week of September 5, 2012
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Product Detail
| Product Description | 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. |
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| Recall Number | Z-2281-2012 |
| Classification | Class II |
| Code Info | All lots of Eon Mini (Product Code 65-3788) |
| Product Distributed Qty | 30,560 units |
| Reason For Recall | 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. |
Event Detail
| Event Id | 61171 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Advanced Neuromodulation Systems Inc. |
| City | Plano |
| State | TX | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2011-12-19 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | 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. |
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