Events

Percepta CRT-P MRI SureScan (W1TR04) and Percepta Quad CRT-P MRI SureScan (W4TR04) 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-2018-RN-00831-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-07-05
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00831-1
  • 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
    Medtronic have identified that when an ap-vs interval measures 100-109ms during a short, nightly device check, a single reset is generated. this reset produces a non-programmable, wireless carealert, but does not alter device therapy. if the device experiences more than five resets due to this timing sequence between in-clinic device interrogations, a full reset (sometimes referred to as a power on reset) will occur. by design, a full reset automatically reverts device operation to rv-only pacing at vvi/65 until the next programmer session is conducted – at which time the full reset condition can be cleared, and the device can be reprogrammed to its prior settings.
  • 조치
    Medtronic are advising that a software update, Application SW040 Version 8.1, is available for installation onto all CareLink Model 2090 and Encore programmers to eliminate this issue. Once installed, an in-clinic device interrogation will update the patient's device automatically to prevent this timing interaction from generating a reset. Surgeons are advised: - To contact their local Medtronic Representative to schedule installation of the updated Percepta CRT-P Application Software onto Medtronic 2090 and Encore Programmers. - For a patient who has been implanted with a Percepta CRT-P device, consider scheduling an in-clinic device interrogation as soon as possible following installation of the updated application software, for the patient’s device to receive the automatic update.

Device

Percepta CRT-P MRI SureScan (W1TR04) and Percepta Quad CRT-P MRI SureScan (W4TR04)
  • 모델명 / 제조번호(시리얼번호)
    Percepta CRT-P MRI SureScan (W1TR04) and Percepta Quad CRT-P MRI SureScan (W4TR04)ARTG Numbers: 291818 (Medtronic Australasia Pty Ltd - Percepta CRT-P MRI SureScan W1TR04 - Biventricular pacemaker)291819 (Medtronic Australasia Pty Ltd - Percepta Quad CRT-P MRI SureScan W4TR04 - Biventricular pacemaker)
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd

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