Events

EnTrust VR/DRI AT 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
    2018-06-28
  • 사례 출판 날짜
    2018-06-28
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180628b.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 entrust vr/dri at implantable cardioverter defibrillators medical device manufacturer, medtronic, has issued a medical device safety alert concerning its entrust vr/dri at (icds) [model: d154atg, d154vrc]. the manufacturer has identified of the potential for loss of high voltage and anti-tachycardia pacing therapy in the affected products as they near elective replacement indicator (eri) voltage. according to the manufacturer, under certain circumstances, the device may display an immediate end of life (eol) observation with no prior eri alert. though no eri alert is triggered there may not be enough remaining battery capacity to charge the high voltage circuits, resulting in an excessive charge time eol observation, leading to a loss of high voltage and anti-tachycardia pacing therapy. bradycardia therapies will continue to operate as expected. through 15 jun 2018, the manufacturer has confirmed 25 charge timeout events related to the issue, with no patient deaths or complications. time from implant to the devices experiencing the issue is ranging from 7.9-11.7 years. the affected users are recommended to take the following actions: consider scheduling an in-office patient follow-up as soon as possible to assess the potential for the issue. ensure the “excessive charge time eol...And the low battery voltage eri ...” patient alerts have been programmed to "on-high" instruct patients to contact manufacturer if they hear device alert tones. consider utilizing the "demonstrate tones...” function to ensure patients recognize the audible tone. if the issue has occurred, an "eol: replace device immediately" observation will be displayed on the quicklook report. schedule a device replacement immediately. additionally, the manufacturer recommends the actions to help ensure patient safety and effective high voltage therapy remain as the device battery voltage approaches its 2.61v eri threshold the manufacturer will offer a supplemental device warranty for prophylactic replacements as defined under the patient management recommendations. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 28 june 2018.

Device

EnTrust VR/DRI AT Implantable Cardioverter Defibrillators
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Medtronic EnTrust VR/DRI AT Implantable Cardioverter Defibrillators
  • 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