Events

Alerta De Seguridad para Pacemaker Without Cables NANOSTIM

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por St. Jude Medical. Cardiac Rhythm Management Division.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    A1611-505
  • Número del evento
    2015DM-0013702
  • Fecha
    2016-11-09
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=115
  • Notas / Alertas
    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.
  • Notas adicionales en la data

Device

Pacemaker Without Cables NANOSTIM
  • Modelo / Serial
    NANOSTIM S1DLCP, specific serials.
  • Descripción del producto
    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
  • Empresa matriz del fabricante (2017)
    Abbott Laboratories
  • Comentario del fabricante
    “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