Events

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. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Guidant do Brasil 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    740
  • 날짜
    2003-09-17
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Should any questions arise regarding this update, the company is available for further clarification.
  • 원인
    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.
  • 조치
    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