Events

Retiro De Equipo (Recall) de Device Recall Eon Mini Neurostimulation (IPG) System

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 Advanced Neuromodulation Systems Inc..

¿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
    61151
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1983-2012
  • Fecha de inicio del evento
    2011-12-19
  • Fecha de publicación del evento
    2012-07-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-07-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107420
  • 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
    The firm has received 112 complaints of the eon mini ipgs that lost the ability to communicate or recharge due to a workmanship issue resulting in loss of pain relief and subsequent explant. the firm has determined the cause of these reports to be related to process variances in the positioning of the internal battery and printed circuit board, causing a short, and therefore, prematurely depletin.
  • Acción
    St. Jude Medical sent an Important Medical Device Recall letter dated December 19, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were issued the following instructions: For unimplated inventory of affected product customers should contact their SJM Representative to have the device returned to St. Jude Medical. A replacement device will be provided at no additional cost to them. For implanted affected product it is recommended that customers do not unnecessarily explant the devices associated with this advisory if the IPGs are functioning as intended. If there is a sudden loss of power or if the duration between recharges becomes significantly shorter, customers should contact their St. Jude Medical Representative. If device replacement is required due to IPG failure related to this voluntary recall notice, St. Jude Medical will provide a replacement IPG at no charge. For questions regarding this recall call 972-309-2154.

Device

Device Recall Eon Mini Neurostimulation (IPG) System
  • Modelo / Serial
    Model Number 3788. All lots manufactured prior to September 20, 2010.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide) and internationally to Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Puerto Rico, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
  • Descripción del producto
    Eon Mini Neurostimulation (IPG) System (Model 3788); || The product is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
  • Manufacturer
    Advanced Neuromodulation Systems Inc.

Manufacturer

Advanced Neuromodulation Systems Inc.
  • Dirección del fabricante
    Advanced Neuromodulation Systems Inc., 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