Events

Alerte De Sécurité sur Product Name: EON MINI NEUROSTIMULATION SYSTEM Technical Name: EON MINI NEUROSTIMULATION SYSTEM ANVISA Registration Number: 10332340246 Hazard Class: IV Hazard Class: 3788

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par St. Jude Medical Brasil LTDA; 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
    2189
  • Date
    2017-02-02
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    We recommend immediate replacement of the charger for patients who report or have reported excessive heating during charging: - For other patients, replacement of the charger is suggested at the next visit. - After the replacement, the proper operation of the Eon Mini LE Model 3722 Charger must be confirmed. In case of difficulties with the operation of the Eon Mini Model 3722 Charger, due to the depth of the implant, the patient should continue to use the Mini Model 3721 Eon Charger (eg older charger), following the precautions provided in the July letter of 2012. These precautions are as follows: - If the temperature at the implant site becomes uncomfortable during loading: - Stop the recharge until the discomfort disappears and then continue recharging; - Reposition the antenna over the implant site; - Consider a more frequent and shorter recharge; - If the temperature is still uncomfortable, please contact your doctor, SJM representative, or St. Jude Medical Brazil technicians. - Avoid pressing the antenna between the body and a surface that can retain heat, such as a bed or a chair. - The use of topical anesthetics, balsamic medicine, and / or pain relief adhesives at the implant site before or during loading is not recommended as it may reduce the ability to perceive heat or excessive heating near or at the implant site. - Do not carry the device while sleeping. - Do not consume alcohol immediately before or during loading.
  • Cause
    St. jude medical would like to pass on an "important medical device information" regarding the potential overheating or temperature rise at the location where the generator is positioned during the recharge of the implantable pulse generator for eon mini spinal stimulation. some patients may report a temperature rise at the generator implant site during the recharge of the eon mini stimulation system. in brazil, we only had one reported case that was already solved with the change of the loader.
  • Action
    Field Action Code Eon Mini 3788 triggered under the responsibility of the company St. Jude Medical Brasil LTDA. Company will make correction in the field.

Device

Product Name: EON MINI NEUROSTIMULATION SYSTEM Technical Name: EON MINI NEUROSTIMULATION SYSTEM A...

Manufacturer

St. Jude Medical Brasil LTDA; 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
    ANVSANVISA