Events

Alerta De Seguridad para Implantable Cardioverter Defibrillator

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 Medtronic Inc. || Medtronic Europe S. A.R.L.

¿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
    A1709-412
  • Número del evento
    2017DM-0016423 ; 2017DM-0016469
  • Fecha
    2017-09-12
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=73
  • 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 a software problem generated by a certain programming sequence that could lead to loss of stimulation in the left ventricle (lv) in all the referenced devices, for which it has already obtained the necessary approvals and is ready to start updating the software. all programmers to correct the problem, in order to reduce the risk of potentially serious adverse events occurring to patients.

Device

Implantable Cardioverter Defibrillator
  • Modelo / Serial
    Claria and Wide CRT-D MRI, serial RPB603896S, RPB603895S
  • Descripción del producto
    The CLARIA MRI system is indicated for use in patients with a high risk of sudden death due to ventricular tachyarrhythmias and who suffer from heart failure with ventricular dyssynchrony. The device is designed to provide atrial, ventricular or both atrial pacing, cardioversion and defibrillation for the automatic treatment of atrial, ventricular tachyarrhythmias, or both, which may endanger the patient's life.
  • Manufacturer
    Medtronic Inc. || Medtronic Europe S. A.R.L

Manufacturer

Medtronic Inc. || Medtronic Europe S. A.R.L
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “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