Product name: Implantable Neurostimulator for Deep Brain Stimulation (Anvisa registration number: 10339190485), Active Rechargeable Programmable Neurostimulator RC (Anvisa record number: 10339190528), Activa® SC Programmable Neurostimulator (Anvisa registration number: 10339190338), DBS Extension Kit for Deep Brain Stimulation (Anvisa registration number: 10339190463); Neurostimulator Medtronic Spelling Model 7426 (Anvisa registration number: 10339190191), Medtronic Kinetra Neurostimulator Model 7428 (Anvisa registration number: 10339190152) /// Lots: ALL LOTS /// Product risk class: IV - maximum risk.

제조사

  • 제조사 모회사 (2017)
  • 제조사 의견
    “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