Events

Alerte De Sécurité sur Specify electrode kit, models 39565 and 39286, registration 10339190365, risk class IV, several batches (SEE ANNEX).

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 Medtronic Comercial Ltda..

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
    1787
  • Date
    2015-01-06
  • 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
    Reinforced the need to read the new Instruction of Use. #### UPDATED ON 07/24/2017, the company submitted the field action completion report proving the sending of the safety notice to the customer, change in the instruction of use in the product registration.
  • Cause
    Instructions for use of 5-6-5 and 2x8 specify surgical conductors are not distinguish between intraoperative pacing test with a permanent surgical conductor and use for interoperative test evaluation.
  • Action
    Change of Instructions for Use. Action Code FA691. The team should be aware that 5-6-5 and 2x8 Specify ™ surgical conductors are not intended for use for interoperative testing (ie, testing / screening outside the operating room with an external neurostimulator).

Device

Specify electrode kit, models 39565 and 39286, registration 10339190365, risk class IV, several b...

Manufacturer

Medtronic Comercial Ltda.
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “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
    ANVSANVISA