Events

Alerte De Sécurité sur Technical Name: Instrumental Kit ANVISA Registration Number: 10339190545 Hazard Class: I Model Affected: 9731958, 9734833, 9734834, 9734835, 9734836, 9735283, 9735284, 9735285, 9735465, 9735500 , 9735522, 9735607

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; Medtronic Navigation, Inc..

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
    2306
  • Date
    2017-05-29
  • 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
    Quarantine any copies of version 25 until they can be removed. ### UPDATED ON 10/25/2017, the company submitted completion report of the field action proving the accomplishment of corrective action of the software.
  • Cause
    Medtronic has verified a problem related to the stealthstation ™ 57 ™ system and the synergy ™ spine version 2.1 application. this problem may result in the user being unable to navigate the navigated elevate inserter with the stealthair spine frame during spinal surgery procedures. there are no reports of injury to the patient associated with this problem.
  • Action
    Field Action Code FA764 triggered under the responsibility of the company MEDTRONIC COMERCIAL LTDA. Company will make correction in the field.

Device

Technical Name: Instrumental Kit ANVISA Registration Number: 10339190545 Hazard Class: I Model Af...

Manufacturer

MEDTRONIC COMERCIAL LTDA; Medtronic Navigation, Inc.
  • 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