Trade name: Double Chamber 2 Step Marker (Ingenio 2). Technical Name: Dual Chamber Implantable Cardiac pacemaker, with Frequency Response. ANVISA registration number: 10341350824. Class of risk: IV. Model affected: L200; L210; L310; S701 .. Serial numbers affected: See attached list on the Anvisa portal at the following link: http://portal.anvisa.gov.br/informacoes-tecnicas13/-/asset_publisher/WvKKx2fhdjM2/content/alerta-2450-tecnovigilancia-boston- pacemaker-dual-2-ingenuity-2-problem-fault-in-signal-of-sensor / 33868 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Boston Scientific do Brasil Ltda; Boston Scientific Limited 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
  • 사례 ID
    2450
  • 날짜
    2017-12-28
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • 데이터 추가 비고
    Boston Scientific is actively developing a software upgrade designed to automatically detect and resolve this signal over-detection behavior of the MV sensor. Until software is available to automatically resolve MV sensor signal over-detection, Boston Scientific recommends managing the risk for patients implanted with affected pacemaker systems as follows: • For pacemaker dependent patients, change the MV sensor to "OFF". Note that when programmed to passive, the MV sensor signal is enabled and may be over-detected. See Appendix B for details on changing the MV sensor to "OFF". • For all other patients, evaluate the risks of over-detection of the MV sensor signal against the benefits of the pace indicated on the MV sensor. If the risk exceeds the benefit, change the MV sensor to "OFF" (see Appendix B). • If out-of-range, transient, or abrupt changes in RA / RV rhythm impedance measurements are observed, contact Boston Scientific Technical Services to explore all noninvasive programming options before surgery. In most cases, system management can be done non-invasively through schedule changes. • According to the manual of the pacemaker, if MV sensor signal artifacts are observed in EGMs and the electrodes are working properly, consider programming the sensor to "OFF" to avoid over detection. • For patients with the MV sensor enabled, periodically reassess the dependence of the pacemaker. If you wish to notify technical complaints and adverse events use the following channels: Notivisa: Notices of adverse events (AE) and technical complaints (QT) for products subject to Sanitary Surveillance should be made through the NOTIVISA System. To access the System, you must register and select the Health Professional option, if you are a liberal professional or the Institution / Entity option, if you are a professional of an institution / entity. Technovigilance System: Patient or citizen can notify through the Technovigilance System / SISTEC access through the link Additional information: - Date of identification of the problem by the company: 12/13/2017 - Date of notification notice to Anvisa: 12/28/2017 The company that owns the affected product is responsible for contacting its customers in a timely manner. to ensure the effectiveness of the Field Action in progress. It stands out the joint responsibility of the distribution chain and use of health products in maintaining its quality, safety and efficacy, as well as the effectiveness of the Field Action, expressed by RDC 23/2012: "(...) Art 2 ° A holder of registration of health product is the holder of the registration / registration of health product with Anvisa. Single paragraph. The registration holder, as well as other agents involved from the production to the use of the product, or discarding it when applicable, are jointly and severally responsible for maintaining the quality, safety and efficacy of the health products to the final consumer. Art. 12 Distributors of health products shall forward to the registration holder, in a timely manner, the distribution map and other information requested for the notification and execution of field actions. (...) "
  • 원인
    Boston scientific initiated voluntary notification from reports of intermittent over-detection of minimal ventilation (mv) sensor signal with certain pacemakers and cardiac resynchronization pacing systems from boston scientific. it has been shown that a high potential of mv sensor signal over-detection in certain pacemaker systems connected to competitors pacing electrodes. although all electrodes evaluated in simulated test environments comply with the appropriate connector standards, boston scientific has observed subtle differences between electrode manufacturers in the electrode end ring surface finish and amount of axial and radial terminal ring movement within the electrode pacemaker connector block. these factors can result in intermittent increases in impedance leading to over-detection of the mv sensor signal or changes in impedance test measurements daily. we apologize for any inconvenience this action may cause, and appreciate your understanding as we take action to ensure patient safety and customer satisfaction. we are committed to continuing to deliver products that meet the highest quality standards you expect from boston scientific.
  • 조치
    Field Action Code 2017-011 triggered under the responsibility of Boston Scientific do Brasil Ltda. Will make field correction

Manufacturer

  • 제조사 모회사 (2017)
  • 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
    ANVSANVISA