Events

Retiro De Equipo O Alerta De Seguridad para Implantable Automatic Defibrillators (DAIs) EllipseTM VR / DR, models CD1411-36Q, CD1411-36C, CD2411-36Q, CD2411-36C, CD1377-36QC, CD1377-36C, CD2377-36QC and CD2377-36C

Según Agencia Española de Medicamentos y Productos Sanitarios (Via FOI), este evento ( retiro de equipo o alerta de seguridad ) involucró a un dispositivo médico en Spain que fue producido por St. Jude Medical CRMD.

¿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
    Recall / Safety Alert
  • Fecha
    2016-04-12
  • País del evento
    Spain
  • Fuente del evento
    AEMPSVFOI
  • Notas / Alertas
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Notas adicionales en la data
  • Acción
    Possibility that certain EllipseTM Implantable Cardioverter Defibrillators (ICDs), manufactured by St. Jude Medical CRMD, USA, can not administer high voltage therapy, so the device must be replaced to patients carrying them.

Device

Implantable Automatic Defibrillators (DAIs) EllipseTM VR / DR, models CD1411-36Q, CD1411-36C, CD2...

Manufacturer

St. Jude Medical CRMD
  • 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
    AEMPSVFOI