Events

EnTrust implantable cardioverter-defibrillators 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Medtronic 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
    2012-03-06
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20120307.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
    Safety alert over certain medtronic implantable cardioverter-defibrillators the department of health (dh) today (march 6) received notification from a medical device supplier, medtronic international ltd (medtronic), about its voluntary corrective actions concerning some models of entrust and escudo implantable cardioverter-defibrillators (icd). the icds concerned may not meet the expected longevity or provide at least three months of device operation between the elective replacement indicator (eri) and end of life (eol) due to a more-rapid-than-expected drop in battery voltage. according to medtronic, the entrust model numbers affected are d153drg, d153vrc, d153atg, d154vrc, d154drg and d154atg, and escudo d144drg and d144vrc. among the affected models, only entrust d154vrc and d154atg were ever launched in hong kong, but they are no longer marketed here now. medtronic has identified the cause of the problem to be an internal battery short that develops as the battery capacity is consumed. so far, no patient deaths or serious injuries have been reported as a result of this issue. medtronic reported that 51 patients in hong kong have been implanted with the affected models in both private and public hospitals. the manufacturer is in the process of informing the physicians-in-charge of the patients about the problem and the related management recommendations. a dh spokesman advised those patients who have the affected devices implanted should contact their physicians immediately if they feel unwell or have any queries. the department has alerted the hospital authority, private hospitals, relevant institutions and medical associations to the safety alert. while dh has not received any adverse report so far, the department will maintain vigilance and monitor the development of the issue. ends.

Device

EnTrust implantable cardioverter-defibrillators
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Press release: Safety alert over certain Medtronic implantable cardioverter-defibrillators
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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