Events

Safety Alert for Commercial name: Intra-Operative Magnetic Resonance Imaging System Polestar N30 //// ANVISA record: 10339190462 /// Risk class: II. Affected model (s); PoleStar N-30 Systems and Batch (s) / Serial Number (s) Affected. One unit of system no. 3122 (distributed to São Paulo-SP).

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

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
    1928
  • Date
    2016-06-28
  • 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
    Recommendations to Users and Patients: Share this Urgent Security Notice with all those who work at your facility and use the PoleStar Surgical MRI System to have Medtronic perform an on-site inspection to verify and correct the ground connection on your PoleStar N -30. #### UPDATED ON 7/24/2017, Medtronic filed the field action completion report, verifying that the customer safety notice and equipment repair were submitted.
  • Reason
    Recently, in conducting internal tests, medtronic has identified a possible ground discontinuity in these subassemblies (warning light box and coolers), leading to a possible risk of electric shock to the user when in direct contact with these subsets. the risk assessment carried out concluded that the risk of electric shock to the user is low. in addition, the residual risk levels of the system have not changed and remain acceptable. in the medtronic risk assessment, there was no change in the risk to the patient since the assemblies were located outside the operating room. medtronic took immediate action to review and correct this problem. medtronic will perform an on-site inspection to verify and correct the ground connection on your polestar n-30 system.
  • Action
    Correction in Parts and Parts Field /// Recommendations to users and patients. Action code FA725.

Device

Commercial name: Intra-Operative Magnetic Resonance Imaging System Polestar N30 //// ANVISA recor...

Manufacturer

MEDTRONIC COMERCIAL LTDA; MEDTRONIC NAVIGATION ISRAEL, LTD.
  • 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