Events

Emblem and SQ-RX Subcutaneous-Implantable Cardiac Defibrillators (S-ICDs) 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-00830-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-07-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00830-1
  • 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 informed of a single, isolated s-icd event that resulted in a device-related patient death in may of 2017. boston scientific engineers have determined that this patient’s s-icd repeatedly delivered an atypical amount of energy (similar to the arrhythmia induction function) because a specific memory location was corrupted by radiation within the environment. this repeated atypical energy delivery prevented s-icd arrhythmia detection/treatment and ultimately contributed to the patient death. this device behaviour has been simulated in a laboratory setting by corrupting two specific adjacent bits of device memory on similar model s-icds, and the test results correlated with the information available from this event. although this device behaviour is highly unlikely to reoccur, an s-icd software update is being developed to mitigate the effects of memory corruption by preventing atypical energy delivery.
  • 조치
    Boston Scientific are developing a software update (v4.04 or higher) that addresses the behaviour. In the interim, Boston Scientific recommends NO changes to clinical follow-up due to this single event. Specifically, for patients with S-ICD systems: 1. Continue using the S-ICD system to detect and treat life-threatening ventricular tachyarrhythmias; 2. Keep scheduled LATITUDE and/or in clinic follow-ups; and 3. Follow the precautions identified in the S-ICD user’s manual when radiation therapy is prescribed. Furthermore, Boston Scientific does NOT recommend the following: 4. Early or off-cycle follow-ups are not recommended. This type of memory corruption cannot be detected, thus additional S-ICD checks do not reduce the potential for this device behaviour. 5. Prophylactic S-ICD replacement or explant is not recommended. The risks associated with such an additional surgical procedure significantly outweigh the risk of reoccurrence of this device behaviour.

Device

Emblem and SQ-RX Subcutaneous-Implantable Cardiac Defibrillators (S-ICDs)
  • 모델명 / 제조번호(시리얼번호)
    Emblem and SQ-RX Subcutaneous-Implantable Cardiac Defibrillators (S-ICDs)Emblem S-ICDsModel Numbers: A209 and A219SQ-RX S-ICDModel Number: 1010ARTG Numbers: 260382, 286705 & 219499
  • 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