Events

Boston Scientific AUTOGEN DR Implantable Cardioveter-Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) 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-2014-RN-01223-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-11-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01223-1
  • 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 autogen dr icds and crt-ds include the option of enabling a right ventricular automatic threshold (rvat) test to determine the rv pacing threshold and adjust amplitude in an ambulatory setting. if the rvat test feature is enabled and noise signals are continuously sensed within a brief rv noise window following an atrial pace, a patient may not receive effective pacing support until the rvat test ends (i.E., up to 20 cardiac cycles). although no patients have been harmed in the cases reported to date, brief periods of dizziness were reported in one case. note that there is no additional risk for patients in whom the rvat feature is disabled.
  • 조치
    Boston Sci is developing a S/W solution that will prevent this device behaviour from occurring when the RVAT test feature is enabled. Following appropriate regulatory approval, this S/W solution will be implemented via a non-invasive download from the programmer. Until a S/W solution can be implemented, Boston Sci recommends the following: 1)For ambulatory RVAT tests, it is recommended that the RVAT test feature is not enabled in AUTOGEN DR ICDs and CRT-Ds, due to the potential risk of asystole occurring during the RVAT test. If the ambulatory RVAT test feature has been enabled, Boston Sci recommends disabling the RVAT feature at the first opportunity, but within 3 months. 2) For in-clinic/commanded RVAT tests, it is recommended that physicians test thresholds manually, rather than utilising the automatic RVAT test.For more information, please see http://www.tga.gov.au/alert/autogen-dr-implantable-cardioverter-defibrillator-and-autogen-cardiac-resynchronisation-therapy-defibrillator . This action has been closed-out on 18/03/2016.

Device

Boston Scientific AUTOGEN DR Implantable Cardioveter-Defibrillators (ICDs) and Cardiac Resynchron...
  • 모델명 / 제조번호(시리얼번호)
    Boston Scientific AUTOGEN DR Implantable Cardioveter-Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) AUTOGEN CRT-D Model Numbers: G172 / G173 / G175 / G177 / G179 AUTOGEN DR ICD Model Numbers: D046 / D047 / D176 / D177 ARTG numbers: 221642, 221643, 221640, 221618, 221615, 221616, 221641, 221633, 221617
  • 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