Deep Brain Stimulation (DBS) system

Fabricante

  • 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.
  • Source
    DH

3 dispositivos con un nombre similar

Más información acerca de la data acá

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    Models 64001 and 64002
  • Descripción del producto
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  • Modelo / Serial
    Models 37085 and 37086
  • Descripción del producto
    Deep Brain Stimulation Therapy
  • Manufacturer
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medtronic Neuromodulation Deep Brain Stimulation (DBS) system pocket adaptors
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