Events

Retiro De Equipo (Recall) de ISOLINE 2CR6 and 2CT6 Implantable Defibrillation Leads

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Sorin Group Australia.

¿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
  • ID del evento
    RC-2013-RN-00088-2
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-01-31
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00088-2
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    As of december 31, 2012, 30 cases of internal insulation breach under the rv or svc defibrillation coil have been confirmed by the analysis conducted on returned products. in each of the 30 identified cases, the internal insulation breach of the silicone lumen was observed under the rv and/or svc defibrillation coil, i.E. where the microcables are not coated with etfe, resulting in a contact between the conductors, thus leading to low pacing impedance and/or ventricular oversensing, and/or inappropriate therapy. it should be noted that in case of ventricular oversensing, pacing is inhibited.
  • Acción
    Sorin Group Australia is issuing a 'Hazard Alert' letter to implanting/ treating clinicians and hospitals detailing the issues and how to manage the affected patients. The TGA has published a web statement regarding the issues. For more information, please see http://www.tga.gov.au/safety/alerts-device-isoline-leads-130306.htm .

Device

ISOLINE 2CR6 and 2CT6 Implantable Defibrillation Leads
  • Modelo / Serial
    ISOLINE 2CR6 and 2CT6 Implantable Defibrillation LeadsPrevious ARTG numbers (cancelled in Nov 2011) : 165673, 165674Multiple serial numbers
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Sorin Group Australia

Manufacturer

Sorin Group Australia