Medtronic Inc || Medtronic Neuromodulation || Medtronic Puerto Rico, Operations Co. || Medtronic Puerto Rico Operations Co., Villalba. || Medtronic B.V.

  • Manufacturer Parent Company (2017)
  • 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
  • 1 Event

One device in the database

  • Model / Serial
    3065USC, Lots N478119, N478167, N478170, N478441, N478559 and N478643.
  • Product Description
    INTERSTIM systems are designed to administer therapeutic nerve-type electrostimulation through the product components.