Events

Alerte De Sécurité sur electronic medullary stimulation 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 St. Jude Medical Puerto Rico, Llc. || Advanced Neuromodulation Systems, Inc. || St Jude Medical.

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
    I1607-292
  • Numéro de l'événement
    2009DM-0003333
  • Date
    2016-07-25
  • 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=131
  • 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
  • Cause
    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
  • Modèle / numéro de série
    3701, specific lots.
  • Description du dispositif
    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
  • 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