FDAFDA · Alimentos y medicamentos·N.º oficial Z-2280-2012
Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be connected to 4, 8, or 16 electrode leads or a lead extension. 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.
Publicado el 5 de septiembre de 2012 · Inicio del retiro: 19 de diciembre de 2011
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
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.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Advanced Neuromodulation Systems Inc.
- Distribuidor
- 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.
- Lote
- All lots of the Eon (Product Code 65-3716)
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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