Events

VALITUDE X4 CRT-P U128 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Cardiac Pacemakers 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
    22363
  • 사례 시작날짜
    2017-12-15
  • 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: Boston Scientific NZ Ltd, Level 1, 3 Diamond Street, Newton, Auckland
  • 원인
    The manufacturer has received reports of intermittent oversensing of the minute ventilation (mv) sensor signal with certain pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). mv sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. this mv behavior may occur with any manufacturer's pacing lead system, but the manufacturer has determined it to be more likely for affected pacemakers using medtronic or abbott/st. jude (abbott) leads implanted in either the right atrium (ra) or right ventricle (rv).
  • 조치
    Manufacturer to issue advice regarding use

Device

VALITUDE X4 CRT-P U128

Manufacturer

Cardiac Pacemakers Inc
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    NZMMDSA