Events

Convert+ Model V-195 Implantable Cardioverter-Defibrillator (ICD) 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 St. Jude Medical 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
    2010-05-06
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20100507.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
    Software defect causes malfunction in implantable cardioverter-defibrillator the department of health (dh) today (may 6) received notification from st. jude medical (hong kong) ltd., a local branch of a multi-national company, about a software problem in its convert+ model v-195 implantable cardioverter-defibrillator (icd). the model, if programmed by a merlin pcs programmer running version 7.2.1, version 8.2.1 or version 10.2.0 software, may not deliver therapy under certain circumstances. the defect can be corrected. st jude medical recommends doctors who have programmed a patient's device with any of the affected software versions should schedule a follow-up visit to perform the correction recommended by it. according to st. jude medical (hong kong) ltd., one patient has been implanted with this model of icd in hong kong. however, the implanted device has not been programmed with the affected software version. this model of icd ceased to be sold by the company in hong kong since mid-2007. no patient injury or death has been reported worldwide. patients may call st. jude medical (hong kong) ltd. at 9682 0488 for further details. a dh spokesman reminded patients with implanted icds that they should seek medical attention immediately if they felt unwell. meanwhile, the dh has informed both public and private hospitals, and relevant medical associations of the issue, and will also follow up with st. jude medical (hong kong) ltd. on further development, if any. end/thursday, may 6, 2010.

Device

Convert+ Model V-195 Implantable Cardioverter-Defibrillator (ICD)
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Press release: Software defect causes malfunction in implantable cardioverter-defibrillator
  • Manufacturer
    St. Jude Medical

Manufacturer

St. Jude Medical
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DH