Events

Model 3200 programmer for Emblem, Emblem MRI 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-00077-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-01-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00077-1
  • 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
    There is potential for radio frequency (rf) interference to alter wireless communication from the model 3200 programmer, which in rare instances may cause an s-icd to perform an unintended command, such as the unintended initiation of pg-based tachyarrhythmia induction of a patient, or a command that results in therapy being unavailable after the telemetry session has ended, both of which could result in patient death. this behaviour can only occur during an active, in-clinic interrogation/programming session with the model 3200 s-icd programmer. there is no risk of this behaviour occurring when the latitude patient management system communicates with an s-icd in an ambulatory setting. to date, a total of ten observations of unintended programming commands or data changes have been observed, with no instances of permanent injury or death.
  • 조치
    Boston Scientific is developing software to mitigate this issue. Until updated software is available, recommendations that mitigate the risks associated with this issue, and which are detailed in the customer letter, are to be followed.

Device

Model 3200 programmer for Emblem, Emblem MRI and SQ-Rx Subcutaneous-Implantable Cardiac Defibrill...
  • 모델명 / 제조번호(시리얼번호)
    Model 3200 programmer for Emblem, Emblem MRI and SQ-Rx Subcutaneous-Implantable Cardiac Defibrillators (S-ICDs) ARTG Number: 260383
  • 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