Events

Trade name: POCKET ADAPTER EXTENSION ADAPTER. ANVISA registry number: 10339190354. Class of risk: IV. Affected model (s): 64001 and 64002 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 MEDTRONIC COMERCIAL LTDA 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
    1966
  • 날짜
    2016-06-21
  • 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
    #### UPDATED ON 08/23/2017, the company submitted completion report of the field action proving the action of reinforcing the instructions for use of the product.
  • 원인
    This letter reports recent results from the review of the returned product, medtronic neuromodulation pocket dynamic adapter (dbs) with high impedance reporting, and reinforces specific device labeling for pocket adaptor manipulation and integrity during implant procedures. this applies to the pocket adaptor models 64001 and 64002 that can be used with the following implantable neurostimulators: activa® pc (model 37601) and activa® rc (model 37612).
  • 조치
    Field Action FA724 Recommendations for Users and Patients: The current labeling for system manipulation during implantation is described in the implant manuals. To minimize the possibility of a connector wire breakage, follow the instructions in the DBS Pocket Adapter System Implant Manual as described below to ensure that the adapter wire is not bent severely or bent at the time of implantation. The complete implant manual can be found on the product packaging. Implanting the Pocket Adapter with the Neurostimulator: 1. Place the Pocket Adapter behind the neurostimulator. Wrap the adapter wire and excess extender wire behind the adapter, making sure the wires do not bend too tightly. Also, perform a thorough inspection of the integrity of the system by checking proper electrode impedances before closing the as described in the Activa® PC Model 37601 Implant Manual.

Device

Trade name: POCKET ADAPTER EXTENSION ADAPTER. ANVISA registry number: 10339190354. Class of risk:...

Manufacturer

MEDTRONIC COMERCIAL LTDA
  • Source
    ANVSANVISA