FDAFDA · Alimentos y medicamentos·N.º oficial Z-0278-2014
Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation.
Publicado el 20 de noviembre de 2013 · Inicio del retiro: 30 de septiembre de 2013
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 notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the following specific conditions: Switching between groups with Multiple programs or creating program groups. Therapy can be restored with the Physician Recharge mode (RPM) of the Implantable Neurostimulator Recharger (INSR).
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Medtronic Neuromodulation
- Distribuidor
- Worldwide distribution: US (Nationwide) including Puerto Rico; and countries of: Algeria, Aruba, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malta, Martinique, Mexico, Morocco, Netherlands, Netherlands Antilles, New Caledonia, Norway, Oman, Pakistan, Panama, Peru, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, and Venezuela.
- Lote
- all serial numbers
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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