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 St. Jude Medical Puerto Rico, Llc. || Advanced Neuromodulation Systems, Inc. || St Jude Medical.

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 ID
    I1607-292
  • Event Number
    2009DM-0003333
  • Date
    2016-07-25
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=131
  • 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
  • Reason
    The manufacturer reports that it has detected the increase in temperature or heating at the gpi implant site during the load, reporting burns located in the implant site, leading to possible adverse events on the patient.

Device

electronic medullary stimulation system
  • Model / Serial
    3701, specific lots.
  • 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: syndrome of failure of the back surgery, as well as back pain and pain in lower limbs difficult to cure. EON / EON MINI neurostimulation system: are indicated for the treatment of chronic and intractable pain of the trunk and / or extremities, including unilateral or bilateral pain associated with some of the following cases; failure syndrome of back surgery, as well as low back pain and pain in lower limbs difficult to cure. MULTIPROGRAM TRIALSTIMULATOR system: it is used for the stimulation of the spinal cord (eme) in the treatment of chronic trunk pain and extremities, either as an individual palliative method or with other types of treatment in the case of pluridisciplinary therapy. This system of modular stimulation is indicated as adjuvant in the treatment of chronic pain in the trunk and extremities, including unilateral or bilateral pain associated with angina pectoris and peripheral vascular disease.
  • Manufacturer
    St. Jude Medical Puerto Rico, Llc. || Advanced Neuromodulation Systems, Inc. || St Jude Medical

Manufacturer

St. Jude Medical Puerto Rico, Llc. || Advanced Neuromodulation Systems, Inc. || St Jude Medical
  • 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