FDAFDA · Alimentos y medicamentos·N.º oficial Z-0025-2013
The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need. 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.
Publicado el 17 de octubre de 2012 · Inicio del retiro: 4 de septiembre de 2012
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
Eon Mini IPGs manufactured in April 2012 could potentially exhibit a sudden, brief surge in stimulation that would be felt by the patient as uncomfortable or painful. SJMs routine testing, monitoring, and analysis of manufacturing processes identified three lots of Eon Mini IPGs that the internal battery has the potential to come into contact with the internal microcontroller board.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Advanced Neuromodulation Systems Inc.
- Distribuidor
- US Nationwide Distribution
- Lote
- Eon Mini - 3788 (IPG), Multiple Serial Numbers
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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