Events

Retiro De Equipo (Recall) de Synchromed II

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 MEDTRONIC.

¿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
    2008-06-06
  • 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/rappel-et-recommandation-de-suivi-de-pompes-implantables-synchromed-ii-medtronic
  • 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
    In agreement with Afssaps and following the discovery of a manufacturing defect on certain devices, the company MEDTRONIC proceeded on June 5, 2008, at the recall of implantable pump lots Synchromed models 8637-20 and 8637-40 not still implanted mentioned in the attached mail and has issued recommendations for the management of patients already implanted by these lots. The implant doctors of these pumps, the directors and local correspondents of materiovigilance of the health establishments concerned in France received the mail of recommendations attached (05/06/2008) (269 ko). The directors and local correspondents of materiovigilance of the health establishments concerned in France have received the attached recall (05/06/2008) (33 KB). The competent European authorities have been informed of this measure by the manufacturer. This information is addressed to the directors of health establishments and local correspondents of materiovigilance for diffusion to the concerned services.

Device

Synchromed II

Manufacturer

MEDTRONIC
  • 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
    LAANSM