Events

InSync III Cardiac Resynchronisation Therapy Pacemakers (CRT-P) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medtronic Australasia 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-2015-RN-01108-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-11-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01108-1
  • 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 an issue with insync iii crt-ps related to long-term battery performance because of unexpected high battery impedance. unexpected high battery impedance can result in the battery’s inability to supply sufficient electrical current, impacting device function. if pacing capture is compromised, some patients may experience a return of heart failure symptoms due to loss of biventricular pacing. in cases involving pacemaker-dependent patients, a loss of pacing capture could result in serious injury or death. insync iii crt-pacemakers are no longer distributed. current devices have a modified battery design that is not susceptible to this issue.Through 27 october 2015, the events have occurred in devices with implant durations of 53 months or more. medtronic's modelling predicts an estimated failure rate between 0.16% and 0.6%. there is no provocative testing that can predict which specific devices may fail, and there is no programming that can mitigate this issue.
  • 조치
    Medtronic is issuing following recommendations to cardiologists and surgeons for managing patients with an InSync III CRT-pacemaker: - Prophylactic device replacement in non-pacemaker-dependent patients is not recommended. - For pacemaker-dependent patients, physicians should carefully weigh the risks and benefits of device replacement to mitigate this issue on an individual patient basis. The estimated per patient mortality risk of this issue (0.007% to 0.02%) is comparable to the estimated per patient mortality risk of complications associated with an incremental, early device replacement (0.005%). - Continue routine patient follow up in accordance with standard practice, and advise patients to seek medical attention immediately if they experience new or unexpected symptoms. Medtronic is also including a draft patient letter for cardiologists and surgeons to contact their patient about this matter. Also, Medtronic is offering a supplemental device warranty. For further information please see https://www.tga.gov.au/alert/insync-iii-cardiac-resynchronisation-therapy-pacemakers . This action has been closed-out on 20/04/2017.

Device

InSync III Cardiac Resynchronisation Therapy Pacemakers (CRT-P)

Manufacturer

Medtronic Australasia Pty Ltd
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA