Events

Safety Alert for 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.

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

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
    740
  • Date
    2003-09-17
  • 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
    Should any questions arise regarding this update, the company is available for further clarification.
  • Reason
    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