Events

Retiro De Equipo (Recall) de Device Recall Brio DBS 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
    61554
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0894-2013
  • Fecha de inicio del evento
    2012-03-28
  • Fecha de publicación del evento
    2013-02-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108418
  • 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, electrical, implanted, for parkinsonian tremor - Product Code MHY
  • Causa
    Unintended fluid ingress into the device header has been shown.
  • Acción
    St. Jude Medical sent an Important Product Field Corrective Action Device Information letter dated March 28, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for any unused product, isolate the affected product for return to St. Jude Medical. Their local representatiave would collect the unused inventory. Any unused product would be replaced with product once inventory becomes available. For patients with implanted product and no degradation of therapy, it is recommended dthat the devices not be unnecesssarily explanted. For patient with implanted product who experience diminished or loss of therapy customers were advised to follow the steps provided in the letter. Customers were asked to forward the notification to any institution in the event one or more patients or products could be potentially affected by this action. Customers wsere asked to maintain a record of thenotice along with the recommendations to ensure the effectiveness of the communication. For questions regarding this recall call 972-309-2154.

Device

Device Recall Brio DBS System
  • Modelo / Serial
    Model number 6788. All lots manufactured prior to 03/16/2012 are being recalled.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - 53 consignees out of the US.
  • Descripción del producto
    Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.
  • 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