Medtronic Inc. Cardiac Rhythm Disease || Medtronic Neuromodulation || Medtronic Bv || Medtronic Puerto Rico Operations Co., Villalba.

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Description

  • 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
    NIDFSINVIMA
  • 1 Event

One device in the database

  • Model / Serial
    37714 and 97714, specific serials.
  • Product Description
    It is used to evaluate neurostimulation systems. For chronic and untreatable pain of the trunk and / or limbs including unilateral and bilateral pain