Events

Sprint Fidelis family of implantable defibrillation leads 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Medtronic International Ltd. 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
  • 날짜
    2007-10-15
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20071015.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • 데이터 추가 비고
    Press release
  • 원인
    Voluntary suspension of defibrillation leads the department of health (dh) today (october 15) received a notification from a medical device manufacturing company concerning its decision to voluntarily suspend the worldwide distribution of four models of implantable defibrillation leads (components of a device to regulate a patient's heartbeat) due to the potential for lead fractures. the notification from medtronic international ltd involved the sprint fidelis family of implantable defibrillation leads. the four models are 6930, 6931, 6948 and 6949. according to the company, over 200 such leads have been distributed to hong kong . so far, dh has not received any report of death or injury in hong kong associated with the devices. dh will closely monitor the development. dh has alerted the hospital authority, the private hospitals and the medical professional institutions of the notification and advised them to check with the supplier. according to the company, lead fractures may present as audible alerts, inappropriate shocks and/or loss of output. individual patients who think they may have been implanted with the devices in question should contact their attending doctors. doctors are advised to immediately stop implanting the devices and contact the company for more information on how to follow-up with patients who have implanted with the leads concerned. the manufacturer did not recommend immediate replacement of the leads in all patients except in very unusual circumstances. patients may call the medtronic international ltd's hotline at 2907 5911 from 9:00 am to 5:30 pm on monday to friday for details about the notification. ends/monday, october 15, 2007.

Device

Sprint Fidelis family of implantable defibrillation leads

Manufacturer

Medtronic International Ltd.
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH