Events

Model 5348 Single-Chamber External Pulse Generator 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-2014-RN-00495-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-05-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00495-1
  • 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 has identified the development of high resistance on internal electrical connector contacts due to oxidation over time. due to the unpredictable nature of the oxidation process on multiple electrical contacts, this issue may result in one or more of the following: • pacing rate outside of the intended setting, potentially including a sudden increase in pacing rate up to the maximum setting of 180 ppm. • output amplitude or sensitivity outside of intended setting. • pace, sense, or low battery led indicators not lighting during power on or reset functions. • rapid atrial pacing (rap) display with intermittent functionality. • intermittent functionality of the on/off and rap control buttons.
  • 조치
    Medtronic recommends that the following actions be taken when using a potentially affected Model 5348 EPG: • Monitor the EPG function and patient’s heart rhythm continuously while the EPG is in use to ensure it is operating properly and delivering appropriate therapy to the patient. • If any malfunction is observed with a 5348 EPG, ensure the patient’s condition is stabilized, discontinue use of the Model 5348 device and contact your Medtronic representative. During the design and development of new models, Medtronic identified that a service life of five years is most appropriate for an External Pulse Generator. Therfore, Medtronic is advising customers that they will no longer provide standard servicing of EPGs (calibration, physical inspection or repair) that are more than five years old including these potentially affected 5348 EPGs. Continued use of the device will require end users to perform the relevant maintenance procedures to ensure safe and effective operation of the devices.

Device

Model 5348 Single-Chamber External Pulse Generator
  • 모델명 / 제조번호(시리얼번호)
    Model 5348 Single-Chamber External Pulse Generator Serial number ranges : PEP001001P to PEP050019P and PEP001001K to PEP001714K ARTG number: 128599
  • 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