Synchromed II implantable drug infusion pump

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
    AFMPS

16 dispositivos con un nombre similar

Más información acerca de la data acá

  • Modelo / Serial
    Pump Identification: in Europe, Middle East, Africa, Latin America and India any pump with a Use By Date on or before 2018-12-31 was manufactured prior to design change. An image of the Shelf Box Side Label of the SynchroMed II is shown in attached
  • Descripción del producto
    Infusion Pump.
  • Manufacturer
  • Modelo / Serial
  • ¿Implante?
    Yes
  • Descripción del producto
    Active implantable medical devices
  • Manufacturer
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