Events

SQ-RX pulse generators 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Cameron Health, Inc 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
    2011-06-07
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20110607.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 cameron pulse generators the department of health (dh) has drawn public attention to a field safety advisory relayed by the uk medicines and healthcare products regulatory agency concerning possible premature battery depletion in a number of sq-rx pulse generators by cameron health. the pulse generators are a component of the cameron health s-icd system, which is an implantable cardioverter-defibrillator prescribed for patients when cardiac arrhythmia management is warranted. according to the advisory, spotted via dh's regular surveillance, medical device manufacturer cameron health, inc. determined that a specific subset of sq-rx pulse generators, model number 1010 may not achieve the five-year typical longevity due to premature battery depletion. premature battery depletion under this condition may also result in the time between the onset of the elective replacement indicators (eri) and end of life (eol) indicators to be less than the nominal three months. therapy remains available through the onset of eri, but may not be available throughout the period between eri and eol. cameron health has confirmed one occurrence of a device experiencing premature battery depletion as described above but no patient injury or deaths related to this condition have been reported. while dh is following up with the manufacturer on the supply of the device in hong kong, a spokesman urges patients who might have the affected device implanted to contact their physicians immediately should they notice an audible tone emitted from the device or should they have any queries. the department has alerted the hospital authority, private hospitals, relevant institutions and medical associations to the field safety notice. while dh has not received any adverse report so far, the department will maintain vigilance and monitor the development of the issue.

Device

SQ-RX pulse generators
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Press release: Safety alert over certain Cameron pulse generators
  • Manufacturer
    Cameron Health, Inc

Manufacturer

Cameron Health, Inc
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH