Retiro De Equipo (Recall) de Device Recall EnTrust VR ICD

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 Medtronic Inc. Cardiac Rhythm Disease Management.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Implantable cardioverter defibrillator (non-crt) - Product Code LWS
  • Causa
    A small percentage of entrust icds may not meet expected longevity or provide at least three months of device operation between the elective replacement indicator (eri) and end of life (eol) due to a more-rapid-than-expected drop in battery voltage.
  • Acción
    An "Urgent Medical Device Correction" letter was sent to physicians beginning 3/6/2012. The letter described the issue and provided patient management recommendations. Additionally the letter stated that ongoing updates to the product performance report will be posted on a Medtronic website.


  • Modelo / Serial
    all serial numbers
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution -- USA, and the countries of: Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jamaica, Jordan, Kuwait, Lebanon, Macedonia, Martinique, Morocco, Netherlands, Netherlands Antilles, New Zealand, Norway, Oman, Peru, Poland, Portugal, Qatar, Reunion, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • Descripción del producto
    Medtronic EnTrust, Single Chamber Implantable, Cardioverter Defibrillator with Ventricular Therapies, models D153VRC and D154VRC. The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment for automated treatment of life-threatening ventricular arrhythmias. Sterile. Medtronic, Inc., Minneapolis, MN 55432 USA.
  • Manufacturer


  • Dirección del fabricante
    Medtronic Inc. Cardiac Rhythm Disease Management, 8200 Coral Sea St. N.E., Saint Paul MN 55112
  • Empresa matriz del fabricante (2017)
  • 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