Events

Safety Alert for Ventak Prizm 2 DR, Contak Renewal and Contak Renewal 2 CRT-Ds, Ventak Prizm AVT, Vitality AVT, Renewal 2 AVT and Renewal 4 AVT.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Guidant Corporation/EUA.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    808
  • Date
    2005-06-20
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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
  • Reason
    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