Events

Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra devices(Implantable cardiac defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices) Manufactured between January 2010 and May 2015 Fortify VRFortify ST VRFortify Assura VRFortify DRFortify ST DRFortify Assura DRUnifyUnify QuadraUnify Quadra MPUnify AssuraQuadra AssuraQuadra Assura MP 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-2017-RN-01122-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-08-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01122-1
  • 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) is providing additional information following on from the previous notification in october 2016 (rc-2016-rn-01316-1).Previously there was no method to identify devices subject to premature battery depletion prior to reaching the eri voltage. sjm have developed battery performance alert (bpa) for patients who have impacted devices.The bpa will provide notification of abnormal battery performance prior to premature battery depletion, & before eri voltage. battery information is uploaded nightly to merlin.Net where the most recent 32 days of data are analysed each day to determine any anomalous battery voltage trend. once the bpa is triggered, notification is provided to physicians through merlin.Net and the merlin programmer during routine follow-up evaluations. for patients not followed remotely with merlin.Net, the status of their battery/whether the bpa has triggered an alert can only be determined with in-person interrogation using the merlin programmer.
  • 조치
    St Jude Medical is advising customers: 1. Do not implant unused affected devices. 2. Conduct patient follow-up per standard practice. 3. Prophylactic device replacement is NOT recommended because complications following replacement have been reported to occur at a greater rate than the rate of harm associated with premature battery depletion due to lithium cluster induced shorts. 4. In the event of a BPA or ERI indicator in these devices, immediate device change is recommended. (Updated recommendation) 5. Follow directions in the customer letter regarding battery monitoring in patients of already-implanted devices.

Device

Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra de...
  • 모델명 / 제조번호(시리얼번호)
    Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura and Unify Quadra devices(Implantable cardiac defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices)Manufactured between January 2010 and May 2015Fortify VRFortify ST VRFortify Assura VRFortify DRFortify ST DRFortify Assura DRUnifyUnify QuadraUnify Quadra MPUnify AssuraQuadra AssuraQuadra Assura MPMultiple ModelsMultiple ARTG Numbers
  • 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