Events

Safety Alert for Specify electrode kit, models 39565 and 39286, registration 10339190365, risk class IV, several batches (SEE ANNEX).

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
    1787
  • Date
    2015-01-06
  • 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
    Reinforced the need to read the new Instruction of Use. #### UPDATED ON 07/24/2017, the company submitted the field action completion report proving the sending of the safety notice to the customer, change in the instruction of use in the product registration.
  • Reason
    Instructions for use of 5-6-5 and 2x8 specify surgical conductors are not distinguish between intraoperative pacing test with a permanent surgical conductor and use for interoperative test evaluation.
  • Action
    Change of Instructions for Use. Action Code FA691. The team should be aware that 5-6-5 and 2x8 Specify ™ surgical conductors are not intended for use for interoperative testing (ie, testing / screening outside the operating room with an external neurostimulator).

Device

Specify electrode kit, models 39565 and 39286, registration 10339190365, risk class IV, several b...

Manufacturer

Medtronic Comercial Ltda.
  • 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