Events

Safety Alert for Trade name: DBS Electrode for Deep Brain Stimulation. Technical Name: CABLE / ELECTRODE FOR DEEP BRAIN ELECTRIC STIMULATION SYSTEM. ANVISA registration number: 10339190484. Class of risk: IV. Model Affected: 3387 / 3387-28 / 3387-40 / 3387S / 3387-40. Serial numbers affected: see attachment

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
    2409
  • Date
    2017-11-16
  • 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
    N / A If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AEs) 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: 01/03/2017 - Date of notification notice to Anvisa: 11/16/2017 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
    In march 2017, medtronic notified physicians about safety information regarding the depth limiter included in all dbs electrode kits of the deep brain stimulation procedure. based on the potential risk related to the lack of the product and considering that medtronic's neurostimulators and extensions are not compatible with non-medtronic electrode tests, it is recommended to use the dbs electrode kit stock until product replacement is available.
  • Action
    Field Action Code FA761 Phase II triggered under the responsibility of the company MEDTRONIC COMERCIAL LTDA. Will Make Gathering

Device

Trade name: DBS Electrode for Deep Brain Stimulation. Technical Name: CABLE / ELECTRODE FOR DEEP ...

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