Events

Notificaciones De Seguridad De Campo acerca de bepaalde Cardiale Resynchronisatie Therapie-pacemakers  en -defibrillatoren

Según Inspectie Gezondheidszorg en Jeugd, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Netherlands que fue producido por Cardiac Pacemaker Inc.

¿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
  • Fecha
    2017-12-19
  • País del evento
    Netherlands
  • Fuente del evento
    IGJ
  • URL de la fuente del evento
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2017/12/19/cardiac-pacemaker-pacemakers-en-defibrillatoren
  • Notas / Alertas
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notas adicionales en la data
  • Causa
    This letter contains important programming information to prevent unintended asynchronous biventricular (biv) pacing behavior during tracking of increased intrinsic atrial rhythms in certain boston scientific cardiac resynchronization therapy pacemakers (crt-ps) and defibrillators (crt-ds).

Device

bepaalde Cardiale Resynchronisatie Therapie-pacemakers  en -defibrillatoren

Manufacturer

Cardiac Pacemaker Inc
  • 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.” Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
  • Source
    IGJ