Events

Nanostim Leadless Cardiac Pacemaker (LCP) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 St Jude Medical Australia 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-01460-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-11-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01460-1
  • 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
    St jude medical (sjm) has identified that patients with nanostim leadless cardiac pacemakers may experience loss of telemetry and pacing due to battery malfunction. investigation by sjm found decreased battery capacity due to reduced electrolyte, resulting in high internal battery resistance. this disrupts the required capacity for proper device function and reduces device longevity. there have been seven (7) reports worldwide of lost telemetry and pacing output as a result of a battery malfunction. battery malfunction may be indicated with a loss of telemetry/communication with the implanted device and/or loss of pacing and magnet mode operation. these events occurred between 29 and 37 months post implant. no patient injuries have been reported in association with the loss of bradycardia pacing therapy.
  • 조치
    St Jude Medical has contacted the cardiologists who have implanted Nanostim leadless cardiac pacemakers providing further information about the above issue including patient management recommendations. They have been instructed to stop implanting these devices into new patients. For more information, please refer to https://www.tga.gov.au/alert/nanostim-leadless-cardiac-pacemaker . This action has been closed-out on 15/05/2017

Device

Nanostim Leadless Cardiac Pacemaker (LCP)
  • 모델명 / 제조번호(시리얼번호)
    Nanostim Leadless Cardiac Pacemaker (LCP)Model Number: S1DLCP Supplied in Australia under Clinical Trial Notification (CTN) scheme
  • Manufacturer
    St Jude Medical Australia Pty Ltd

Manufacturer

St Jude Medical Australia Pty Ltd
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DHTGA