Events

Safety Alert for Deep Brain Neurostimulation 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 ID
    R1709-396
  • Event Number
    2014DM-0011366
  • Date
    2017-09-04
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=74
  • 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

Deep Brain Neurostimulation System
  • Model / Serial
    3387-XX, 3389-XX and 3391-XX, specific lots
  • Product Description
    A deep brain stimulation therapy of MEDTRONIC is indicated for the unilateral or bilateral stimulation of the internal pallid balloon (IPG) or the sub-thalamic nucleus (STN) in the following cases: Parkinson's disease: indicated for adjuvant therapy in the reduction of some of the symptoms of Parkinson's disease advanced in patients with a response to levodopa and that is not adequately controlled with medication. Essential tremor and dikinesias: indicated for the suppression of tremor in the upper extremities. Designed for patients diagnosed with essential tremor or tremor associated with Parkinson's disease not adequately controlled by medication and where tremor constitutes a significant loss of functionality. Dystonia: indicated as an aid for the treatment of intractable chronic primary dystonia (resistant to medication), including generalized and segmental dystonia, hemidystonia, and cervical ladisthonia (torticollis), for persons 7 years of age or older. Epilepsy: indicated as adjuvant therapy to reduce the frequency of seizures in adult patients diagnosed with epilepsy characterized by initial partial seizures with or secondary syngeneization resistant to antiepileptic drugs. Obsessive-compulsive disorder: indicated for bilateral stimulation of the internal capsule of the anterior limbus (AIC) as an adjunct to medication and as an alternative for the treatment of chronic compulsive obsessive-compulsive disorder resistant to treatment with deserotonin inhibitors.
  • 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