Events

Safety Alert for Trade name: Synchromed II Implanted Infusion Pump. Technical Name: Infusion Pump. ANVISA registration number: 10339190229. Risk class: IV. Model affected: 8637-20 E 8637-40. Affected serial numbers: See Distribution list and Batch Affected

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Medtronic Comercial Ltda; Medtronic, Inc..

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
    2420
  • Date
    2017-11-17
  • 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
    There are no additional recommendations. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 09/11/2017 - Date of notification notice for Anvisa: 11/17/2017 The company that owns the affected product is responsible for contacting its customers in due time. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • Reason
    The purpose of this letter is to inform you that medtronic has received approval to implement a design change in the synchromed® ii implantable drug infusion pump, which reduces the likelihood of engine shut down, which may result in loss of therapy. for pumps manufactured prior to this design change, an analysis of our post-marketing data estimates that the pump's ability to survive specific non-recoverable engine shutdown at 6 years post-implant is 97.3% for pumps exposed to the indication of the label and 91.1% 2 for pumps exposed to medicinal products outside the indication of the label. the most common contributing factor for engine shutdown is axle wear, and this condition is observed in 59% of synchromed ii pumps returned and analyzed for engine shutdown. engineering tests estimate that this new design change covers more than 99% of shaft wear, and will reduce the occurrence of engine shutdown.
  • Action
    Field Action Code FA794 Phase I triggered under the responsibility of the company Medtronic Comercial Ltda. It will notify the customers of the design change.

Device

Trade name: Synchromed II Implanted Infusion Pump. Technical Name: Infusion Pump. ANVISA registra...

Manufacturer

Medtronic Comercial Ltda; Medtronic, Inc.
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA