Events

VALITUDE CRT-P, MOMENTUM CRT-D, AUTOGEN CRT-D, VISIONIST CRT-P, DYNAGEN CRT-D 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Boston Scientific Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2017-RN-01510-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-12-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01510-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Boston scientific has been made aware of unintended asynchronous biventricular (biv) pacing behavior when tracking elevated atrial intrinsic rhythms in certain boston scientific cardiac resynchronization therapy (crt) pacemakers (crt-ps) and defibrillators (crt-ds). repeated detection of this unintended asynchronous biv pacing behavior may result in the implanted device reverting to a permanent safety mode (safety core™) status thus requiring early replacement.
  • 조치
    Doctors should review programming records of patients implanted with the CRT devices described in Appendix B of the letter. If the LV Offset parameter is programmed to a Positive value, follow the supplied instructions to determine the need for changing the pacemaker settings. Boston encourages doctors to provide the patient letter to all patients who are implanted with an affected device, and to patients who consent to having the device implanted before the software fix is available. Maintain awareness of this issue until the software fix becomes available, and display this letter in a prominent place. If a positive LV Offset is desired for a newly implanted Boston Scientific CRT device, consider the patient’s individual medical needs and either program the A-Blank after V-Pace value greater than the positive LV Offset value, or disable Tracking Preference by programming it to a value of “OFF”.

Device

VALITUDE CRT-P, MOMENTUM CRT-D, AUTOGEN CRT-D, VISIONIST CRT-P, DYNAGEN CRT-D
  • 모델명 / 제조번호(시리얼번호)
    VALITUDE CRT-PModel U128ARTG 279333RESONATE CRT-DModel G447ARTG 296562MOMENTUM CRT-DModel G124, G125, G126, G128ARTG 296563, 296564, 296565, 296566AUTOGEN CRT-DModels G172, G173, G175, G177, G179ARTG 221615, 221616, 221617, 221618, 221633VISIONIST CRT-PModels U225, U226, U228ARTG 279330, 279331, 279332DYNAGEN CRT-DModels G151, G156, G158ARTG 221620, 221621, 221622
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty Ltd
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DHTGA