Events

Ellipse VR/DR Implantable Cardioverter Defibrillators 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
    2014-08-20
  • 사례 출판 날짜
    2014-08-20
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140820a.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 ellipse vr/dr implantable cardioverter defibrillators the australia therapeutic goods administration (tga) posted a medical device safety alert concerning ellipse vr/dr implantable cardioverter defibrillators (icds) manufactured by st. jude medical. the affected models are cd1277 (-36 and -36q), cd1377 (-36, -36q, -36c and -36qc), cd2277 (-36 and -36q) and cd2377 (-36, -36q, -36c and -36qc). icds with serial numbers beginning with “1” that are below 1132470, beginning with the number “7” that are below 7126267 and all serial numbers beginning with an “8” are affected. the manufacturer has received complaints that extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices. as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value. this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock. according to the manufacturer, there have been no reported cases of an ellipse device failing to deliver high voltage therapy to a patient when needed. the manufacturer is providing appropriate patient management recommendations to surgeons for managing patients who are implanted with the affected devices. furthermore, the manufacturer advises customers that the affected stock will be retrieved and replaced by new ellipse icds with the redesigned high voltage capacitor eliminating the source of capacitor damage at the front alignment hole. for details, please refer to tga website:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00905-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 august 2014.

Device

Ellipse VR/DR Implantable Cardioverter Defibrillators
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: St. Jude Medical Ellipse VR/DR Implantable Cardioverter Defibrillators
  • 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