Events

RestoreSensor Implantable Neurostimulators 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-2016-RN-00521-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-05-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00521-1
  • 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 confirmed 4 instances of loss of therapy during the recharging of a restoresensor implantable neurostimulator, at a rate of 0.007% worldwide. by design, stimulation therapy turns off when the battery voltage depletes below 3.575 volts (< 0% battery level). insufficient coupling (charging efficiency) between the recharger & the implant during the recharge session was found to be a key factor in the reported events which consequently led to the inadequate recharge of the battery & subsequent loss of stimulation therapy. if the insufficient recharge coupling is continued & the battery is not recharged to restart stimulation therapy, the battery can discharge to an over discharge (od) state. under normal use conditions, the patient has 30 days to recharge the device to avoid experiencing a battery od state. in this scenario, this time period is reduced to 1–2 days. if three occurrences of od occur, the implant will trigger end of life, and must be replaced to restore therapy.
  • 조치
    Medtronic advises patients to follow the current recharge instructions, paying particular attention to Charging Efficiency and Battery Charge Level indicators on the recharger, specifically: - Check the neurostimulator battery charge level once a day or more frequently as needed. - Keep the neurostimulator sufficiently charged to maintain therapy. It can be charged at any time; users do not need to wait for a low battery message. - During neurostimulator recharging, monitor the Charging Efficiency row and adjust the antenna to obtain as many solid black boxes as possible. If only two boxes are filled in (6 or more boxes are empty) adjust the antenna to improve the signal strength between the neurostimulator and recharger. - During recharging, ensure the neurostimulator Battery Charge Level is at least 25% before ending the charge session. However, a full battery charge is ideal. - Medtronic is working with the TGA to assess the best approach to resolve the reported issue. This action has been closed-out on 02/03/2017.

Device

RestoreSensor Implantable Neurostimulators
  • 모델명 / 제조번호(시리얼번호)
    RestoreSensor Implantable NeurostimulatorsModel Numbers: 37714, 97714ARTG Numbers: 177594, 215750
  • 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