Events

Product Name: EON MINI NEUROSTIMULATION SYSTEM Technical Name: EON MINI NEUROSTIMULATION SYSTEM ANVISA Registration Number: 10332340246 Hazard Class: IV Hazard Class: 3788 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 St. Jude Medical Brasil LTDA; St. Jude Medical 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    2189
  • 날짜
    2017-02-02
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • 데이터 추가 비고
    We recommend immediate replacement of the charger for patients who report or have reported excessive heating during charging: - For other patients, replacement of the charger is suggested at the next visit. - After the replacement, the proper operation of the Eon Mini LE Model 3722 Charger must be confirmed. In case of difficulties with the operation of the Eon Mini Model 3722 Charger, due to the depth of the implant, the patient should continue to use the Mini Model 3721 Eon Charger (eg older charger), following the precautions provided in the July letter of 2012. These precautions are as follows: - If the temperature at the implant site becomes uncomfortable during loading: - Stop the recharge until the discomfort disappears and then continue recharging; - Reposition the antenna over the implant site; - Consider a more frequent and shorter recharge; - If the temperature is still uncomfortable, please contact your doctor, SJM representative, or St. Jude Medical Brazil technicians. - Avoid pressing the antenna between the body and a surface that can retain heat, such as a bed or a chair. - The use of topical anesthetics, balsamic medicine, and / or pain relief adhesives at the implant site before or during loading is not recommended as it may reduce the ability to perceive heat or excessive heating near or at the implant site. - Do not carry the device while sleeping. - Do not consume alcohol immediately before or during loading.
  • 원인
    St. jude medical would like to pass on an "important medical device information" regarding the potential overheating or temperature rise at the location where the generator is positioned during the recharge of the implantable pulse generator for eon mini spinal stimulation. some patients may report a temperature rise at the generator implant site during the recharge of the eon mini stimulation system. in brazil, we only had one reported case that was already solved with the change of the loader.
  • 조치
    Field Action Code Eon Mini 3788 triggered under the responsibility of the company St. Jude Medical Brasil LTDA. Company will make correction in the field.

Device

Product Name: EON MINI NEUROSTIMULATION SYSTEM Technical Name: EON MINI NEUROSTIMULATION SYSTEM A...

Manufacturer

St. Jude Medical Brasil LTDA; St. Jude Medical
  • 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
    ANVSANVISA