Events

Alerte De Sécurité sur Deep Brain Neurostimulation System

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par manufacturer #121.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    R1709-396
  • Numéro de l'événement
    2014DM-0011366
  • Date
    2017-09-04
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=74
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données

Device

Deep Brain Neurostimulation System
  • Modèle / numéro de série
    3387-XX, 3389-XX and 3391-XX, specific lots
  • Description du dispositif
    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
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “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