Medtronic, Inc. || Medtronic Europe S. A.R.L

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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
  • 1 Event

Un dispositivo en la base de datos

  • Modelo / Serial
    LNQ11
  • Descripción del producto
    The REVEAL LINQ cardiac monitor from MEDTRONIC is a programmable device that continuously monitors the ECG and other physiological parameters of the patient. The device registers cardiac in response to the activation of the patient and the arrhythmias that have been detected automatically. It is indicated in the following cases: Patients with clinical syndromes osituations with greater risk of cardiac arrhythmias. Patients who experience transient symptoms that may suggest cardiac arrhythmia.

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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