Events

Medtronic RestoreULTRA 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Medtronic Inc 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
    16363
  • 사례 시작날짜
    2014-03-12
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Medtronic New Zealand Limited, Unit 16 Mezzanine Level, 5 Gloucester Park Road, Onehunga, AUCKLAND
  • 원인
    Medtronic has updated the labelling for medtronic deep brain stimulation (dbs), spinal cord stimulation (scs), and peripheral nerve stimulation (pns) therapies to include the following., 1. enabling cycling at certain parameter settings may decrease the recharge interval for rechargeable devices and the device longevity of non-rechargeable devices. longevity calculations for non-rechargeable devices during scs trailling with clycling enables as calculated on the n'vision clinician programmer may not be accurate., 2. the current labelling does not address the potential for epidural mass formation and subsequent spinal cord compression.
  • 조치
    Instructions for use to be updated

Device

Medtronic RestoreULTRA
  • 모델명 / 제조번호(시리얼번호)
    Model: Model: 37712, Affected: All devices
  • Manufacturer
    Medtronic Inc

Manufacturer

Medtronic Inc
  • 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
    NZMMDSA