Events

Alerte De Sécurité sur Ventak Prizm 2 DR, Contak Renewal and Contak Renewal 2 CRT-Ds, Ventak Prizm AVT, Vitality AVT, Renewal 2 AVT and Renewal 4 AVT.

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 Guidant Corporation/EUA.

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
    808
  • Date
    2005-06-20
  • 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
    Brazil 21/06/2005 - Given the seriousness of the situation, ANVISA launched a research process, articulated between UTVIG / GGTPS, GGIMP and CVS / SP, with a view to adopting the pertinent measures to ensure the safety of the medical products offered population in Brazil. Among these measures we highlight the identification of GUIDANT DO BRASIL LTDA as the holder of authorization to market the products of Guidant Corporation / USA in national territory. In Brazil only the Contak Renewal H 135 models were implemented - ANVISA Registration no. 10357240087, canceled on 06/22/2004 and Ventak Prizm II DR 1861 - ANVISA Registry no. 10357240067, canceled on 07/05/2004. The existence of 92 implantable cardioverter-defibrillators at the national level was reported to ANVISA-Tecnovigilance Unit, of which 62 were from VentaK Prizm 2 DR (model 1861) and 30 Contak Renewal (model H 135). ANVISA, through the UTVIG, began monitoring these implantable cardioverter-defibrillators by tracking down the professional users - doctors who performed the implants. This monitoring is being done in conjunction with the company BIOTRONIK Indústria e Comércio Ltda. who is providing assistance in relation to technical matters for the company Guidant ..................................... ............................ COMPLEMENTARY INFORMATION ACCESS: http: //www.anvisa.gov.br/divulga/informes/2005/ 290705.pdf
  • Cause
    Occurrence, in the united states, involving 15 records of failures and one death related to the contak pacemaker, and 28 failures and one death related to the ventak model. in addition, the renewal and contak renewal 2 crt-ds, ventak prizm avt, vitality avt, renewal 2 avt and renewal 4 avt models presented problems that compromised product performance.
  • Action
    US health officials have ordered Guidant to recall thousands of pacemakers from the market after it was learned that 45 of them failed and two others caused the same number of deaths. The order refers to three different models of Guidant devices for the treatment of cardiovascular problems. Indianapolis-based Guidant has announced that it will voluntarily advise doctors about the safety of various pacemaker models after the FDA (the US Food and Drug Administration) has ordered the withdrawal of some models. On May 23, the company had told doctors that some of its pacemakers had problems that affected the operation of a small number of them.

Device

Ventak Prizm 2 DR, Contak Renewal and Contak Renewal 2 CRT-Ds, Ventak Prizm AVT, Vitality AVT, Re...

Manufacturer

Guidant Corporation/EUA
  • Source
    ANVSANVISA