Events

Alerta De Seguridad para Trade name: PROGRAMMER N'VISION MEDTRONIC; Medtronic Implantable Infusion Pump Technical Name: IMPLANTABLE DEVICE PROGRAMMER; Infusion Pump ANVISA registration number: 10339190180; 10339190229 Hazard Class: III; IV Model affected: 8840; Synchromed II 8637-20 / Synchromed II 8637-40

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por MEDTRONIC COMERCIAL LTDA.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    2184
  • Fecha
    2016-12-22
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notas adicionales en la data
    New guidelines for priming bolus are listed below. • For a complete system bolus priming: Based on the drug's therapeutic index and patient sensitivity, some individuals may need additional monitoring until the released drug reaches the planned concentration. Do not increase the scheduled daily dose within the first 48 hours after a bolus priming as the released drug may not have reached the planned concentration during that time. • For a complete system priming bolus: Selected priming bolus parameters have been carefully selected based on extensive testing and modeling. To ensure optimal initiation of therapy, no modifications to these values ​​are recommended. • Priming bolus function was not characterized during intravascular administration of floxuridine (FUDR) and methotrexate; therefore, dosing in the first 24 hours may be variable.
  • Causa
    This phase ii of field action 573 is a follow up to the june 2013 notification (see attached copy of that letter for a full description of the problem and possible risks) pertaining to the priming bolus function of synchromed ii and is intended to inform you that medtronic is updating the model 8870 software application card (for version bbu01), as well as the labeling of the synchromed® infusion system to address the problem. the synchromed priming bolus function is intended to rapidly advance the drug from the pump reservoir to the tip of the catheter, allowing the initiation of therapy while the patient remains under medical supervision. the upgraded 8870 software card softens the potential for clinically relevant effects relating to unintended excessive release of the drug during the priming bolus procedure of the whole system. therapeutic applications on the software card for deep brain stimulation and spinal cord stimulation remain unchanged. this letter presents a description of the software change, description of labeling changes, recommendations for 8870 software card, and new recommendations for priming bolus.
  • Acción
    Field Action Code FA573 Phase II triggered under the responsibility of the company MEDTRONIC COMERCIAL LTDA. Company will make correction in the field.

Device

Trade name: PROGRAMMER N'VISION MEDTRONIC; Medtronic Implantable Infusion Pump Technical Name: IM...

Manufacturer

MEDTRONIC COMERCIAL LTDA
  • Source
    ANVSANVISA