Events

Field Safety Notices about Epicardial Lead Models 5071, 4965, and 4968 Sterile Tray

According to Health Products Regulatory Authority, this field safety notices involved a device in Ireland 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 Country
    Ireland
  • Event Source
    HPRA
  • Event Source URL
    http://www.hpra.ie/docs/default-source/Safety-Notices/fsnsummary_mar2010_qmsversion_final_090410.pdf?sfvrsn=0
  • Notes / Alerts
    Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland.
  • Extra notes in the data
    Advice has been provided by the manufacturer regarding a device removal. 3rd Party Publications

Device

Epicardial Lead Models 5071, 4965, and 4968 Sterile Tray
  • Model / Serial
  • Product Description
    Epicardial Lead Models 5071, 4965, and 4968 Sterile Tray
  • Manufacturer
    Medtronic Inc.

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
    HPRA