Events

Alerte De Sécurité sur Technical Name: Instrument Kit ANVISA Registration Number: 10339190545 Hazard Class: I Affected Model: 9734833 Serial Numbers Affected: 0008473885

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
    2288
  • Date
    2017-05-16
  • 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
    Medtronic is reviewing the Statement of Use statement and reinforcing the warning statement in the NavLock ™ instructions, as described below: • Revised Use Indications: NavLock Trackers allow navigation of Medtronic instrumentation used during fusion procedures and intercorporeal connections with Medtronic's StealthStation surgical navigation system. NavLock ™ Trackers should only be used with Medtronic Instruments. • NavLock Current Label Statement: The NavLock ™ Tracker allows navigation of instrumentation used in pedicle preparation during spinal fusion and interbody procedures with a Medtronic computer-aided surgical system. • Enhanced Warning: The NavLock ™ Tracker is designed and tested for use with Medtronic instruments only. The use of non-Medtronic instruments with the NavLock ™ Tracker can create inaccuracies resulting in serious injury or death. #### UPDATED ON 7/24/2017, the company submitted the field action completion report, verifying the sending of the security warning to the customer, change in the usage statement in the product registration.
  • Cause
    Medtronic has been aware of minor, serious injury events, including death of two patients, following procedures in which non-medtronic instruments were used with the navlock ™ tracker.
  • Action
    Field Action Code FA769 triggered under the responsibility of the company MEDTRONIC COMERCIAL LTDA. Company will update, correct or supplement the instructions for use.

Device

Technical Name: Instrument Kit ANVISA Registration Number: 10339190545 Hazard Class: I Affected M...

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