Events

Consulta CRT-D (D234TRK), Secura DR/VR (D234DRG, D234VRC), Maximo II CRT-D (D284TRK) and Maximo II DR/VR (D284DRC, D284VRC) 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Medtronic International Limited 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
    2010-05-05
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20100506.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
    Press release
  • 원인
    Software defects cause malfunctioning in medtronic's implantable cardiac devices the department of health (dh) today (may 5) received notification from medtronic international limited (mil), the local branch of a multi-national medical device manufacturer, that software problems in six of its implantable cardiac devices may risk life-threatening though rare malfunctioning. a dh spokesman said, the affected models are consulta crt-d (d234trk), secura dr/vr (d234drg, d234vrc), maximo ii crt-d (d284trk) and maximo ii dr/vr (d284drc, d284vrc). all except maximo ii vr (d284vrc) are distributed in hong kong. as of april 19 this year, the manufacturer has received five confirmed reports of defect out of approximately 144 000 devices sold worldwide. however, it is reassuring that no patient injury or death arising from the affected devices has been reported thus far. here in hong kong, mil's record shows that a total of 40 affected devices have been implanted in patients of either hospital authority or private hospitals. mil recommends no change to current patient management. the devices will receive software updating upon the patients’ next scheduled clinic follow-up. the company is contacting physicians concerned individually. the spokesman does alert patients who have the deficient implants that if they experience cardiac symptoms or hear alerts from the devices, they should seek medical attention immediately. patients can call mil’s hotline at 2919 6413 for further details. meanwhile, the dh has informed both public and private hospitals, and relevant medical associations of the issue, and will also follow up with mil on further development, if any. ends/wednesday, may 5, 2010.

Device

Consulta CRT-D (D234TRK), Secura DR/VR (D234DRG, D234VRC), Maximo II CRT-D (D284TRK) and Maximo I...
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Press release: Software Defects Cause Malfunctioning in Medtronic's Implantable Cardiac Devices
  • Manufacturer
    Medtronic International Limited

Manufacturer

Medtronic International Limited
  • 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