Events

Fortify ST Implantable cardioverter defibrillator 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
    2013-04-23
  • 사례 출판 날짜
    2013-04-23
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130423.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 fortify st implantable cardioverter defibrillator the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning fortify st implantable cardioverter defibrillator (icd) models [cd1235-40, cd1235-40q, cd2235-40 and cd2235-40q], manufactured by st jude medical. the merlin pcs programmer software model 3330 versions 14.2.2, 16.2.1 and 17.2.1.1 provide new features for st. jude medical pacemakers, icds and crt-ds, including an option to enhance the st diagnostic features in st. jude medical fortify st icd models cd1235-40, cd1235-40q, cd2235-40 and cd2235-40q via a device software upgrade. during a device software upgrade, implanted devices are temporarily placed into the back-up pacing (bvvi) and back-up defibrillation only (bdfo) mode. the back-up mode parameter settings will be in effect for the two minute upgrade process. once the upgrade successfully completes, the device will revert to the previously programmed parameter settings. the safety alert is being provided to ensure that the operation of these devices during backup operation is clearly understood. depending on the individual patient, this temporary change in parameter values could make the device susceptible to over-sensing and potentially deliver high voltage therapy during the upgrade procedure. in order to prevent the potential for inappropriate therapy during the software upgrade process, the manufacturer advises users to consider programming the “tachy therapy enabled/disabled” function to disabled prior to proceeding with the software upgrade. it is imperative to re-interrogate the device and program the “tachy therapy enabled/disabled” function to enabled after the upgrade has been successfully completed. as with any device evaluation and programming, ecg monitoring and availability of back up external defibrillation equipment is recommended during the entire software upgrade process. according to the local supplier, the affected products were distributed in hong kong. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con261823 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 april 2013.

Device

Fortify ST Implantable cardioverter defibrillator
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: St Jude Medical Fortify ST 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