Events

ACTIVA Deep Brain Neurostimulation System 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Medtronic, Inc. || Medtronic Europe S. A.R.L || Medtronic Neuromodulation || Medtronic Puerto Rico Operations Co., Villalba. 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
    A1607-294
  • 사례 연번
    2014DM-0011366
  • 날짜
    2016-07-18
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=132
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer reports that some bag adapters of the referenced systems have high impedances, it is necessary to reinforce the specific technical documentation on the handling of the pocket adapters and the verification of the integrity of the system during the.

Device

ACTIVA Deep Brain Neurostimulation System
  • 모델명 / 제조번호(시리얼번호)
    64001 and 64002, all lots.
  • 제품 설명
    MEDTRONIC deep brain stimulation therapy is indicated for the unilateral orbital stimulation of the internal pale globe (IPG) or the sub-thalamic nucleus (STN) in the following cases: Parkinson's disease: indicated for adjuvant therapy in the reduction of some of the symptoms of advanced Parkinson's disease in patients with a response to levodopa and who do not control it adequately with medication. Trembling and dikinesias: indicated for the suppression of tremor in the upper extremities. Intended for patients diagnosed with essential tremor or tremor associated with Parkinson's disease not adequately controlled by medication and where the tremor constitutes a significant loss of functionality. Dystonia: indicated as aid for the treatment of intractable chronic primary dystonia (resistant to medication), including generalized and segmental dystonia, hemidystonia and cervical dystonia (torticollis), for people 7 years of age or older. Epilepsy: indicated as therapy adjuvant to reduce the frequency of seizures in adult patients diagnosed with epilepsy characterized by initial partial seizures with or without secondary generalization resistant to antiepileptic drugs. Obsessive-compulsive disorder: indicated for the bilateral stimulation of the internal capsule of the anterior limbus (AIC) as a complement to medication and as an alternative for the treatment of chronic obsessive-compulsive disorder resistant to treatment with serotonin inhibitors.
  • Manufacturer
    Medtronic, Inc. || Medtronic Europe S. A.R.L || Medtronic Neuromodulation || Medtronic Puerto Rico Operations Co., Villalba.

Manufacturer

Medtronic, Inc. || Medtronic Europe S. A.R.L || Medtronic Neuromodulation || Medtronic Puerto Ric...
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    NIDFSINVIMA