Events

AUTOGEN DR ICDs and CRT-Ds 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Boston Scientific 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
    2014-11-18
  • 사례 출판 날짜
    2014-11-18
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141118a.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
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: boston scientific autogen dr icds and crt-ds medical device manufacturer, boston scientific, has issued a field safety notice concerning its autogen dr icds and crt-ds. the affected model numbers for autogen crt-d are g172, g173, g175, g177 and g179. the affected model numbers for autogen dr icd d046, d047, d176 and d177. according to the manufacturer, the concerned devices include the option of enabling a right ventricular automatic threshold (rvat) test to determine the rv pacing threshold and adjust amplitude in an ambulatory setting. if the rvat test feature is enabled and noise signals are continuously sensed within a brief rv noise window following an atrial pace, a patient may not receive effective pacing support until the rvat test ends (i.E., up to 20 cardiac cycles). although no patients have been harmed in the cases reported to date, brief periods of dizziness were reported in one case. there is no additional risk for patients in whom the rvat feature is disabled. the manufacturer is developing a software solution that will prevent this device behaviour from occurring when the rvat test feature is enabled. the software solution will be implemented via a non-invasive download from the programmer. until a software solution can be implemented, the manufacturer recommends the following: for ambulatory rvat tests, the manufacturer recommends that the rvat test feature is not enabled in autogen dr icds and crt-ds, due to the potential risk of asystole occurring during the rvat test. if the ambulatory rvat test feature has been enabled, the manufacturer recommends disabling the rvat feature at the first opportunity, but within three months. for in-clinic/commanded rvat tests, the manufacturer recommends that physicians test thresholds manually, rather than utilising the automatic rvat test. according to the local supplier, boston scientific hong kong limited, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 18 november 2014.

Device

AUTOGEN DR ICDs and CRT-Ds
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Boston Scientific AUTOGEN DR ICDs and CRT-Ds
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • 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