Events

Pacemaker Without Cables NANOSTIM 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 St. Jude Medical. Cardiac Rhythm Management Division 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
    A1611-505
  • 사례 연번
    2015DM-0013702
  • 날짜
    2016-11-09
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=115
  • 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

Device

Pacemaker Without Cables NANOSTIM
  • 모델명 / 제조번호(시리얼번호)
    NANOSTIM S1DLCP, specific serials.
  • 제품 설명
    The NANOSTIM wireless pacemaker is indicated for: 1. Chronic atrial fibrillation with second-degree AV block or bifascicular branch block. 2. Inaugural rhythms with second or third degree AV block or branch block and a low level of physical activity or a low expected life expectancy. 3. Sinus bradycardia with pausasaislated or unexplained syncope with electrophysiological results. Uses: the wireless pacemaker NANOSTIM is a pulse generator designed for bradycardia stimulation that incorporates a battery and electrodes and must be implanted in the right ventricle. Since it is a cordless device, it does not need a connector, stimulation cable or pulse generator pocket. A non-retractable distal helix with a single twist fixes the device to the endocardium. In addition, three sutures in the outer part of the head of the device offer a secondary fixation. Detection and stimulation occur between a distal electrode near the helix and the external housing of the device. The proximal end of the device has a mechanism that allows coupling it to the decolocation and extraction catheters for repositioning and extraction. The device is communicated bidirectionally with the programmer by electrical signals that are processed between the electrodes of the implanted device and the skin electrodes attached to the patient's chest and connected to the programmer. Accordingly, the device transmits signals by circuits and electrodes previously designed for stimulation, with data encoded by pulses during the refractory period of the heart. The device detects the blood temperature of the right ventricle and increases the frequency of stimulation as the metabolic requirement increases.
  • Manufacturer
    St. Jude Medical. Cardiac Rhythm Management Division

Manufacturer

St. Jude Medical. Cardiac Rhythm Management Division
  • 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
    NIDFSINVIMA