Events

Accent SR and Accent DR pacemakers 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 St 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
    2012-12-11
  • 사례 출판 날짜
    2012-12-11
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20121211b.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: st. jude medical accent sr and accent dr pacemakers the medicines and healthcare products regulatory agency(mhra), united kingdom posted a field safety notice concerning accent sr and accent dr pacemakers, manufactured by st. jude medical. the manufacturer has identified that a subset of accent sr single chamber model pm1110 and accent dr dual chamber model pm2112 pacemakers will not provide a change in sensor driven (rate responsive) pacing rates in response to patient physical activity due to an incorrect software setting. in devices programmed to a rate-responsive mode, the pacemaker will function in a basic programmed mode and will not provide a sensor driven rate increase when the patient is physically active. all other programmed parameters, features and functions operate as designed, e.G. an accent dr device programmed to dddr will appropriately track atrial activity and properly function in the ddd mode. according to the manufacturer, recall of the unimplanted products is on-going. the manufacturer advises healthcare professionals to: identify affected patient. review affected patient’s clinical indications for pacing and determine the clinical need for rate responsive, sensor driven pacing. in the event that a patient requires rate responsive sensor driven activity pacing and exhibits clinical symptoms due to the lack of increased pacing rates with exercise, contact local sales representative or technical support. continue to follow patients on their standard follow-up schedule. furthermore, according to the manufacturer, a non-invasive programmer software solution will be developed and once it is available, the sensor anomaly can be automatically corrected at follow up by a simple interrogation of the pacemaker. follow up of patients exhibiting clinical symptoms due to the lack of increased pacing rates with exercise should be prioritized. according to local supplier, the affected products were not distributed in hong kong. for details, please refer to the following mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/ con213146 if you are in possession of the product, please contact your supplier for necessary actions. posted on 11 december 2012.

Device

Accent SR and Accent DR pacemakers
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: St. Jude Medical Accent SR and Accent DR pacemakers
  • Manufacturer
    St

Manufacturer

St
  • 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