Events

Retiro De Equipo (Recall) de Device Recall Eon and Eon Mini

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.

¿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
    63947
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1785-2013
  • Fecha de inicio del evento
    2012-11-30
  • Fecha de publicación del evento
    2013-07-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-11-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115091
  • 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
    Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
  • Causa
    There is issues of warmth or heating at the implant site during charging for the eon mini implantable pulse generators (ipgs). in the july 2012 letter st. jude medical informed customers that they would be implementing design improvements to the charger to address possible increased energy dissipation when the charger is misaligned with the ipg or the ipg is implanted too near the surface of the.
  • Acción
    St Jude Medical sent an Important Medical Device Safety Information letter dated November 30, 2012 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter informed customers that a replacement charger for the Eon Mini IPGs is now available and will be provided at no charge. For questions or concerns call St. Jude Medical at 877-650-0367.

Device

Device Recall Eon and Eon Mini
  • Modelo / Serial
    All serial numbers manufactured
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA Nationwide including Puerto Rico and countries of: Austria, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Luxembourg, Martinique, Mexico, Netherlands, Poland, Russian Federal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom.
  • Descripción del producto
    Eon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable Charger) and Eon Mini -3721 (Charger); This is a continuation of the firm's July 2012 recall. || Product Usage: || The Eon Wall Charger (3701) provides the capability to recharge the IPG Battery. The charger transmits RF energy through the antenna to the IPG battery to recharge it. The Eon Portable Charger (3711) provides the capability to recharge the IPG battery. The charger transmits RF energy through the antenna to the IPG battery to recharge it. The patient can be mobile during the recharging process with a portable charger. The Eon Mini Charger (3721) provides the capability to recharge the IPG battery while stimulation is either on or off. The charger transmits RF energy through the antenna to the IPG battery to recharge it.
  • Manufacturer
    St. Jude Medical

Manufacturer

St. Jude Medical
  • Dirección del fabricante
    St. Jude Medical, 6901 Preston Rd, Plano TX 75024-2508
  • 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
    USFDA