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

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Description

  • 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
    NIDFSINVIMA
  • 2 Event

2 dispositivos en la base de datos

  • Modelo / Serial
    model 37751 chargers, used with the following references: Restore, RestoreUltra (Model || 37712), RestoreAdvanced (Model 37713), RestoreSensor || (Model 37714), RestoreUltra SureScan MRI (Model || 97712), RestoreAdvanved SureScan MRI (Model 97713), || RestoreSensor SureScan MRI (Model 97714), serial || specific.
  • Descripción del producto
    It is used to evaluate neurostimulation systems. For chronic and untreatable pain of the trunk and / or limbs including unilateral and bilateral pain.
  • Modelo / Serial
    39565 and 39286, all lots.
  • Descripción del producto
    It is used to evaluate neurostimulation systems. For chronic and untreatable pain of the trunk and / or limbs including unilateral and bilateral pain

Fabricante con un nombre similar

Más información acerca de la data acá

  • 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
    NIDFSINVIMA