Events

Subcutaneous Implantable Defibrillator System 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Boston Scientific Corporation || Cardiac Pacemakers Incorporated 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
    I1701-19
  • 사례 연번
    2014DM-0011699
  • 날짜
    2017-01-26
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=106
  • 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 has detected that there is a possibility that radio frequency (rf) interference alters the wireless communication of the programmer, which in rare cases can cause a pulse generator to activate an unwanted command, this behavior is only possible during an interrogation session. active clinical programming with the programmer, which could lead to the occurrence of potential adverse events on the patient.

Device

Subcutaneous Implantable Defibrillator System
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Administer defibrillation treatment for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not present with symptomatic bradycardia, incessant ventricular tachycardia, or frequent recurrent spontaneous ventricular tachycardia that are safely determined with cardiac pacing contrataquicardias.
  • Manufacturer
    Boston Scientific Corporation || Cardiac Pacemakers Incorporated

Manufacturer

Boston Scientific Corporation || Cardiac Pacemakers Incorporated
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    NIDFSINVIMA