Events

Safety Alert for Activa 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 Medtronic, Inc. || Medtronic Europe S. A.R.L || Medtronic Neuromodulation || Medtronic Puerto Rico Operations Co., Villalba..

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
    I1606-228
  • Event Number
    2014DM-0011366 ; 2008DM-0002561
  • Date
    2016-06-01
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=138
  • 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

Activa Deep Brain Neurostimulation System
  • Model / Serial
    37601, 37602, 37603 and 37612, all series.
  • Product Description
    MEDTRONIC deep brain stimulation therapy is indicated for the unilateral orbital stimulation of the internal pale globe (IPG) or the sub-thalamic nucleus (STN) in the following cases: depharkinson disease: indicated for adjuvant therapy in the reduction of some of the symptoms of advanced Parkinson's disease in patients with a response to levodopa and who do not control it adequately with medication. Trembling and dikinesias: indicated for the suppression of tremor in the upper extremities. Intended for patients diagnosed with essential tremor or tremor associated with Parkinson's disease not adequately controlled by medication and where the tremor constitutes a significant loss of functionality. Dystonia: indicated as aid for the treatment of intractable chronic primary dystonia (resistant to medication), including generalized and segmental dystonia, hemidystonia and cervical dystonia (torticollis), for people 7 years of age or older. Epilepsy: indicated as therapy adjuvant to reduce the frequency of seizures in adult patients diagnosed with epilepsy characterized by initial partial seizures with or without secondary generalization resistant to antiepileptic drugs. Obsessive-compulsive disorder: indicated for the bilateral stimulation of the internal capsule of the anterior limbus (AIC) as a complement to medication and as an alternative for the treatment of chronic obsessive-compulsive disorder resistant to treatment with serotonin inhibitors.
  • Manufacturer
    Medtronic, Inc. || Medtronic Europe S. A.R.L || Medtronic Neuromodulation || Medtronic Puerto Rico Operations Co., Villalba.

Manufacturer

Medtronic, Inc. || Medtronic Europe S. A.R.L || Medtronic Neuromodulation || Medtronic Puerto Ric...
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “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