FDAFDA · Alimentos y medicamentos·N.º oficial Z-0788-2017
Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) Product Usage: The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain, Chronic intrathecal infusion of Lioresal Intrathecal (baclofen Injection ) in the management of serve spasticity, Chronic Intravascular Infusion of Floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer
Publicado el 8 de marzo de 2017 · Inicio del retiro: 3 de octubre de 2016
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 following up to a May 2013 communication regarding the Priming Bolus function for the SynchroMed Infusion System. Medtronic is updating the Model 8870 software application card (to version AAU01) and the SynchroMed pump labeling to address the priming bolus issue.
Qué hacer
Voluntary: Firm initiated · Visit
Detalles del retiro
- Fabricante
- Medtronic Neuromodulation
- Distribuidor
- Worldwide Distribution - (US Nationwide) Internationally to Germany, Greece, Australia, United Kingdom, Switzerland, Italy, Norway, France, Canada, and Malta.
- Lote
- software application cards with versions other than AAU01
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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