Alerta De Seguridad para electronic medullary stimulation system

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por manufacturer #121.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Número del evento
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Colombia.
  • Notas adicionales en la data


  • Modelo / Serial
    3660ANS, 3662ANS, specific serials.
  • Descripción del producto
    Neurostimulation system GENESIS: is indicated as an aid in the treatment of chronic pain, not treatable with other therapies of the trunk or extremities including unilateral or bilateral pain associated with any of the following cases: back surgery failure syndrome, as well as low back pain in lower extremities of difficultness. EON / EON MINI neurostimulation system: there are indicated extremities, including unilateral or bilateral pain associated with some of the following cases; syndrome of failure of back surgery, as well as lower back pain and pain in difficult extremities.System MULTIPROGRAM TRIAL STIMULATOR: used for the stimulation of the spinal cord (eme) in the treatment of chronic pain deltronco and extremities, either as an individual palliative method or other types of treatment in the case of multidisciplinary therapy. This modular stimulation system is indicated as an adjuvant in the treatment of chronic refractory pain of the trunk and extremities, including unilateral or bilateral pain associated with angina and chest pain. peripheral vascular disease. Addition of indications for use: "PRODIGY MRI implantable implant model 3772 and PENTA 3228 and OCTRODE 3186 electrodes are conditional magnetic resonance.The use of these devices is conditionally safe in the MRI environment (magnetic resonance imaging) if a complete MRI system is used. and according to the instructions
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source