Events

St. Jude Medical Ellipse VR/DR Implantable Cardioverter Defibrillators (ICDs) 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-2014-RN-00905-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-08-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00905-1
  • 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 received complaints that extended charge time may present as a result of internal damage to the capacitors used in the high voltage charging circuitry of the subject devices. as designed, the device will deliver the available energy on the capacitors once the charge time limit of 32 seconds is reached, even if the energy is less than the programmed value. this anomaly may occur during capacitor maintenance or charging for high voltage therapy, and may result in delayed delivery of high voltage therapy and/or delivery of part of a programmed high voltage therapy shock. there have been no reported cases of an ellipse device failing to deliver high voltage therapy to a patient when needed.
  • 조치
    St. Jude Medical is providing appropriate patient management recommendations to surgeons for managing patients who are implanted with affected devices. Device replacement is not recommended for an Ellipse device exhibiting normal charge times, and patients should continue to be followed at routine follow-up intervals. Surgeons are advised not to use any Ellipse devices which may be on their shelves. St. Jude Medical is advising customers that the affected stock will be retrieved and replaced by new Ellipse ICDs with the redesigned high voltage capacitor eliminating the source of capacitor damage at the front alignment hole. Ellipse ICDs with serial numbers beginning with the number “1” and starting at 1132470, as well as Ellipse ICDs with serial numbers beginning with the number “7” and starting with 7126267 incorporate the new capacitors and therefore, no affected. This action has been closed-out on 03/02/2017.

Device

St. Jude Medical Ellipse VR/DR Implantable Cardioverter Defibrillators (ICDs)
  • 모델명 / 제조번호(시리얼번호)
    St. Jude Medical Ellipse VR/DR Implantable Cardioverter Defibrillators (ICDs)Models: CD1277 (-36 and -36Q) , CD1377 (-36, -36Q, -36C and -36QC), CD2277 (-36 and -36Q), CD2377 (-36, -36Q, -36C and -36QC) Serial Numbers: beginning with “1” that are below 1132470, beginning with the number “7” that are below 7126267 and all serial numbers beginning with an “8” are affected.ARTG Numbers: 207181, 207182, 207183, 207184, 207185, 207186, 207187, 207189, 202934, 202938, 198821, 198822
  • 의료기기 분류등급
    Cardiovascular Devices
  • 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