Events

Retiro De Equipo (Recall) de Device Recall Epic II VR Model V158

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por St Jude Medical CRMD.

¿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
    46870
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1330-2008
  • Fecha de inicio del evento
    2008-01-16
  • Fecha de publicación del evento
    2008-08-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68591
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
  • Causa
    A condition that could lead to a ventricular sensing anomaly in epic and atlas family of lmplantable cardioverter defibrillators (icds) has been identified. a loss of ventricular sensing would prevent the icd from being able to detect an arrhythmia. if an arrhythmia occurred and the device was unable to detect it, then a patient would not receive potentially life saving therapy.
  • Acción
    A January 16, 2008, letter entitled, "Important Device Upgrade Information" was sent to physicians by FedEx. In the US, sales representatives will follow-up with the physician and will upgrade all programmers. For the rest of the world, it will be monitored by various St. Jude offices and local distributors with this information being fed back to St. Jude Medical CRMD in Sylmar. In addition, St. Jude Medical issued a press release on January 18, 2008 and information concerning this advisory can be found on St. Jude's website, www.sirn.com.

Device

Device Recall Epic II VR Model V158
  • Modelo / Serial
    all serial codes
  • Distribución
    Nationwide and Internationally: Argentina, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Chile, China, Columbia, Costa Rica, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Korea, Malaysia,Mexico, Netherlands, New Zealand, Norway, Peru. Poland, Portugal, Republic of Panama, Singapore, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, United Kingdom, Uruguay and Venezuela.
  • Descripción del producto
    Implantable Cardioverter Defibrillator || EPIC II VR Tiered-therapy cardioverter/defibrillator, Model V-158
  • Manufacturer
    St Jude Medical CRMD

Manufacturer

St Jude Medical CRMD
  • Dirección del fabricante
    St Jude Medical CRMD, 15900 Valley View Ct, Sylmar CA 91342-3577
  • Source
    USFDA