Events

Safety Alert for 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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MEDTRONIC COMERCIAL LTDA.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2184
  • Date
    2016-12-22
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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.
  • Reason
    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.
  • Action
    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