Events

Alerta De Seguridad para Subcutaneous Implantable Defibrillator System

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 Boston Scientific Corporation || Cardiac Pacemakers Incorporated.

¿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
    I1701-19
  • Número del evento
    2014DM-0011699
  • Fecha
    2017-01-26
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=106
  • 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
  • Causa
    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
  • Modelo / Serial
  • Descripción del producto
    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
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “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