Events

Safety Alert for electronic medullary stimulation system

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by manufacturer #121.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event Number
    2009DM-0003333
  • Date
    2017-09-13
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=72
  • Notes / Alerts
    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.
  • Extra notes in the data

Device

electronic medullary stimulation system
  • Model / Serial
    3660ANS, 3662ANS, specific serials.
  • Product Description
    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
    manufacturer #121

Manufacturer

manufacturer #121
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “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
    NIDFSINVIMA