Events

Medtronic Cardiac Resynchronization Therapy and Implantable Cardioverter Defibrillators 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Medtronic 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
    2018-02-28
  • 사례 출판 날짜
    2018-02-28
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180228b.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: medtronic cardiac resynchronization therapy and implantable cardioverter defibrillators the united states food and drug administration (fda) has issued an alert concerning cardiac resynchronization therapy with defibrillation (crt-ds) and implantable cardiovert-defibrillators (icds), manufacturer by medtronic. the affected products are identified as follows: product codes: nik, lws serial numbers: refer to the fda website. manufactured from 13 july 2013 to 8 august 2017. the manufacturer is recalling certain icds and crt-ds due to a defect in the manufacturing process. this defect causes an out of specification gas mixture inside the device and may prevent the device from delivering the electrical shock needed to pace a patient’s heartbeat or revive a patient in cardiac arrest. according to the manufacturer, the delay or inability to deliver a shock to a patient in cardiac arrest or pace a patient’s heart whose heartbeat is too slow could result in serious injury and/or death. the affected customers are asked to take to following actions: consider prophylactic device replacement for patients who have been implanted with one of the affected devices. contact their medtronic sales representative for terms and conditions for device warranties. review the recall notice and ensure appropriate staff is aware of the notice. the manufacturer will offer a supplemental device warranty for affected devices. for details, please refer to the fda website: https://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm598198.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 february 2018.

Device

Medtronic Cardiac Resynchronization Therapy and Implantable Cardioverter Defibrillators
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 제품 설명
    Medical Device Safety Alert: Medical Device Safety Alert
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH