Retiro De Equipo (Recall) de Precision Implantable Pulse Generators

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 Bionics Corp.

¿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
    Implanted spinal-cord stimulator for pain relief - Product Code LGW
  • Causa
    Incorrect data -- corruption of internal memory component results in an inability for the physician to reprogram the ipg with firmware version prior to revision 3.02. when this occurs, the ipg will report an error code of "10h0" or "00h0" through the remote control. under this condition, the ipg will cease to log in some data that could be used for informational purposes. ** it should be noted t.
  • Acción
    Advanced Bionics sent an Important Notification letter on October 5, 2007, via FED-Ex or US Postal Service Certified mail. (International notification activity is in progress.) The recall letter advises that the firm has become aware of an issue with Precision Implantable Pulse Generators (IPG model numbers SC-1100, Sc1110, and ONS-1110) manufactured prior to July 2007. The letter describes the issue in detail. The firm is requesting that customer immediately locate the affected IPGs and set them aside so that they are not used. A Boston Scientific/Advanced Bionics sales representative will contact your facility to confirm these IPGs and arrange for the exchange of these devices. The firm enclosed Reply Verification Tracking Form listing the IPGs that are at your Clinic according to the firm's records. In addition, the firm recommends that if error code 10h0 or 00h0 is encountered in Implanted IPGs, it may be corrected by upgrading to a newer version of IPG firmware (software that runs in the IPG). The new version of firmware corrects this condition and helps prevent it from occurring in the future. This firmware upgrade is performed non-invasively, through wireless RF telemetry. If any of patients encounter error code "10h0" or "00h0" on their Remote Control, consignees are advised to contact their Advanced Bionics representative or Technical Services team at (866) 566-8913 to help identify whether the condition can be corrected through a firmware upgrade and, if so, they will help arrange for the upgrade. Please note that some devices may not be upgradeable. The firm request that all consignees return the notification acknowledgement form is included with the letter.


  • Modelo / Serial
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Class II Recall - Worldwide Distribution --- including USA and countries of EU, Canada, Australia and Israel.
  • Descripción del producto
    Advanced Bionics Precision Implantable Pulse Generator Kit, Model Number: SC-1110 with firmware version prior to Revision 3.02, Advanced Bionics Corportation, Sylmar, CA 91342
  • Manufacturer


  • Dirección del fabricante
    Advanced Bionics Corp, 12740 San Fernando Rd, Sylmar CA 91342-3728
  • Source