Events

Notificaciones De Seguridad De Campo acerca de Aktiva implant – HeartMate II system controller – Thoratec Corporation

Según Swedish Medical Products Agency, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Sweden que fue producido por Thoratec Corporation.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • ID del evento
    6.6.4-2017-27812
  • País del evento
    Sweden
  • Fuente del evento
    SMPA
  • URL de la fuente del evento
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN20161/Aktiva-implantat--HeartMate-II-systemstyrenhet--Thoratec-Corporation/#
  • Notas / Alertas
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products Agency, 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 data from the U.S. and Sweden.
  • Notas adicionales en la data
    FA-Q117-MCS-2
  • Acción
    Information on the risk of use. Modification of products. Modification of the software. Modification of the manual. Modification of labeling.

Device

Aktiva implant – HeartMate II system controller – Thoratec Corporation
  • Modelo / Serial
  • ¿Implante?
    Yes
  • Descripción del producto
    Active implant
  • Manufacturer
    Thoratec Corporation

Manufacturer

Thoratec Corporation
  • 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
    SMPA