Events

Eon Mini Implantable Pulse Generator (IPG) Model 65-3788 and Eon Mini Charging System Model 3721 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-01279-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-12-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01279-1
  • 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
    Some patients have reported experiencing an uncomfortable temperature increase at the ipg implant site during charging, with a small number of patients reporting burns at the implant site. this matter is a follow-up to a hazard alert letter issued by st. jude medical (sjm) in august 2012 (tga reference: rc-2012-rn-00759-3). in the august 2012 letter, st. jude medical informed customers that they would be implementing design improvements to the charger to address the possibility of increased energy dissipation during charging. the new eon mini le charging system model 3722 and eon mini le charger model 3720 reduce the potential for uncomfortable temperature increases that may be felt near the ipg while recharging by automatically turning the energy it delivers on and off. this will require patients to charge longer or more frequently to achieve a full charge.
  • 조치
    St. Jude Medical recommends the prompt replacement of the charger for patients who have reported excessive heating during charging. For other patients, replacement of the charger is recommended at the next follow up. Upon replacement, proper charging function of the Eon Mini LE Charger Model 3720 must be confirmed. The Eon Mini LE Charging System Model 3722 and Eon Mini LE Charger 3720 may not be able to charge implanted IPGs at an implant depth greater than 2.25cm (the Model 3721 was labelled for implant depth up to 2.50cm). In case of difficulties with the charging function of the Eon Mini LE Charger Model 3720 due to the depth of the implant, patients should continue to use their current Eon Mini Charging System Model 3721 following the precautions provided in the August 2012 letter. This action has been closed-out on 04/04/2017.

Device

Eon Mini Implantable Pulse Generator (IPG) Model 65-3788 and Eon Mini Charging System Model 3721

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