Retiro De Equipo (Recall) de Device Recall Rapid Programmer

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.

¿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
    Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
  • Causa
    Product programmed with unapproved software was distributed.
  • Acción
    St. Jude Medical Neuromodulation contacted all affected customers by telephone between June 2, 2009 and June 5, 2009. Customers were given information about the product, problem and action to be taken. All affected devices were returned to the firm as instructed.


  • Modelo / Serial
    Serial numbers: 101565, 101544, 101555, 101548, 101561, 101551, 101563, 101546, 101556, 101553, 101554, 101558, 101545, and 101566
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Distributed in New Hampshire and Puerto Rico.
  • Descripción del producto
    Software version 3.3 for Rapid Programmer devices, Model 3832. || Software version 3.3 for Rapid Programmer devices, a personal digital assistant (PDA) based programmer supporting implantable pulse generators of the Eon, Genesis, and Renew family.
  • Manufacturer


  • Dirección del fabricante
    Advanced Neuromodulation Systems, 6901 Preston Rd, Plano TX 75024-2508
  • Empresa matriz del fabricante (2017)
  • 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