Events

Field Safety Notices about deep brain stimulus connectors , models 37085 and 37086, for use with implantable neurostimulators activa pc, activa rc and activa sc

According to Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, this field safety notices involved a device in Poland that was produced by Medtronic Inc..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event ID
    2564
  • Date
    2015-05-07
  • Event Country
    Poland
  • Event Source
    ORMPMDBP
  • Event Source URL
    http://www.urpl.gov.pl/pl/notatka-bezpiecze%C5%84stwa-firmy-medtronic-inc-dotycz%C4%85ca-%C5%82%C4%85cznik%C3%B3w-do-g%C5%82%C4%99bokiej-stymulacji-m%C3%B3zgu-dbs
  • Notes / Alerts
    Polish data is current through November 2018. All of the data comes from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 recall data from the U.S. and Poland.
  • Extra notes in the data
  • Action
    Security note from Medtronic Inc. regarding connectors for deep brain stimulation (DBS), models 37085 and 37086, for use with implantable neurostimulators Activa PC, Activa RC and Activa SC

Device

deep brain stimulus connectors , models 37085 and 37086, for use with implantable neurostimulator...

Manufacturer

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
    ORMPMDBP