Commercial name: MEDTRONIC PROGRAMMABLE NEUROSTIMULATOR (MODEL 37714) and Generators for Spinal Cord Stimulation RM (MODEL 97714) //. ANVISA registration number: 10339190310 and 10339190453 //. Technical Name: IMPLANTABLE PULSE GENERATOR FOR NEUROSTIMULATION //. Risk class: IV - Maximum risk //. Affected Models: MODELS 37714 (Registry 10339190310) and 97714 (Registry 10339190453) //. Serial numbers affected: Attached list


  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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.
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