Events

Alerte De Sécurité sur This notification is intended to inform that Guidant is circulating a letter to the doctors regarding the pacemakers VIGOR. Although the VIGOR family is not currently marketed, the purpose of the letter is to communicate what doctors can observe during follow-up visits when the device reaches its end-of-service. In addition, this chart provides options that physicians can use to manage the behavior of such devices.

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 do Brasil.

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
    740
  • Date
    2003-09-17
  • 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
    Should any questions arise regarding this update, the company is available for further clarification.
  • Cause
    The behavior of the vigor at the end of service requires more intense monitoring of the patient and, under certain circumstances, has been reported as being difficult to manage. vigor pacemakers are designed to conserve energy by disabling diagnostics and switching to single chamber pacing as they approach the end of service. in addition, near or at the time of exchange, doctors may observe stimulation pauses. these pauses can only occur when interacting with the programmer or during or immediately after an electrocautery. interactions with the programmer and electrocautery occur only in a clinical setting. among all guidant devices, these behaviors are unique to the vigor family of pacemakers.
  • Action
    Guidant's VIGOR pacemakers exceeded their predicted longevity and there were no reports of serious consequences to the patients associated with this behavior. A total of 3,954 pacemakers of the VIGOR family were implanted in patients in Brazil.

Device

This notification is intended to inform that Guidant is circulating a letter to the doctors regar...

Manufacturer

Guidant do Brasil
  • Source
    ANVSANVISA