Events

Alerta De Seguridad para external communicator for implantable cardiac devices

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 Plexus Manufacturing Sdn, Bhd || Medtronic Inc.

¿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
    I1606-244
  • Número del evento
    2014DM-0011380
  • Fecha
    2016-06-09
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=137
  • 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 reports that it has identified a problem with the software that prevents the doctor from accessing the data of the device located in the carelink network, the transmission appears successfully for the patients, while in reality the transmitted data (carealerts) are not visible for the establishment of health, only monitors related to the implantable cardioverter defibrillator (icd) or the cardiac re-synchronization defibrillator (crt-d), which received software updates are unaffected, leading to potential adverse events being presented to patients.

Device

external communicator for implantable cardiac devices
  • Modelo / Serial
    24950
  • Descripción del producto
    The monitor is an external electronic device that communicates with MEDTRONIC implanted cardiac devices and with a telecommunications connection to transmit to the physician the data stored in the implanted cardiac device.
  • Manufacturer
    Plexus Manufacturing Sdn, Bhd || Medtronic Inc

Manufacturer

Plexus Manufacturing Sdn, Bhd || Medtronic Inc
  • Source
    NIDFSINVIMA