Events

Retiro De Equipo (Recall) de Insignia, Contak Renewal TR2 and Vitality 2 models

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por Guidant.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • Fecha
    2006-08-07
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/informations-complementaires-au-retrait-des-stimulateurs-et-defibrillateurs-cardiaques-implantables-de-la-societe-guidant
  • Notas / Alertas
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Notas adicionales en la data
  • Acción
    GUIDANT has withdrawn from the market on July 3, 2006 certain implantable cardiac stimulators and defibrillators of Insignia, Contak Renewal TR2 and Vitality 2 models following recent incidents that revealed the failure of a low-voltage capacitor, leading to a risk of malfunction of these devices. . This withdrawal was accompanied by recommendations for monitoring implanted patients. The company has directly notified the physicians who follow up patients with these devices, using the attached message. validated by Afssaps. Afssaps was informed that the company Guidant had published on August 2, 2006 an update of this information (03/08/2006) (37 KB) stating that other serial numbers were affected by the information broadcast on July 3. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for dissemination, where appropriate to the services concerned. The European competent authorities concerned are informed of this measure by the manufacturer.

Device

Insignia, Contak Renewal TR2 and Vitality 2 models
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    Guidant

Manufacturer

Guidant
  • Source
    LAANSM