FDAFDA · Alimentos y medicamentos·N.º oficial Z-2259-2014
Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. The Activa¿ PC neurostimulator is a dual-channel device capable of delivering bilateral stimulation. Activa PC contains a non-rechargeable battery and microelectronic circuitry to deliver a controlled electrical pulse to precisely targeted areas of the brain. The device is typically implanted subcutaneously near the clavicle, connected to an extension and leads, which are implanted in the brain.
Publicado el 27 de agosto de 2014 · Inicio del retiro: 14 de julio de 2014
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
Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potential for a damaged electrical component during manufacturing.
Qué hacer
Voluntary: Firm initiated · Visit
Detalles del retiro
- Fabricante
- Medtronic Neuromodulation
- Distribuidor
- Distributed in the states of: MA, NC, OH, and TX.
- Lote
- Serial numbers: NKM724776H, NKM724782H, NKM724785H, NKM724790H, NKM724802H, NKM724843H.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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