Events

Retiro De Equipo (Recall) de Device Recall Eon Charging 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 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
    63109
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1738-2013
  • Fecha de inicio del evento
    2012-07-26
  • Fecha de publicación del evento
    2013-07-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-11-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112566
  • 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
    St. jude medical has informed your doctor that a number of cases have been reported in which discomfort associated with heating occurred at the device site while patients were using the charging system to charge their spinal cord stimulator. in three cases, patients received a burn to the skin (one second-degree and two first-degree burns) at the implant site. as of june 30, 2012, st. jude medica.
  • Acción
    ST. Jude Medical sent an Important Medical Device Safety Information dated July 26, 2012 to affected customers. The letter identifed the affected product, problem and actions to be taken. For questions or concerns contact your ST. Jude Medical representative or St. Jude Medical Neuromodulation Division at 1-866-240-6741.

Device

Device Recall Eon Charging System
  • 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: Argentina, Australia, Belgium, Brazil, Canada, China, Chile, Colombia, Ireland, Israel, India, Malaysia, Mexico, Saudi Arabia, Singapore, South Africa, South Korea, Switzerland and United Kingdom.
  • Descripción del producto
    Eon - 3701 (Wall Charger) and 3711 (Portable Charger). || Product Usage: || Eon: Eon system 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. Eon Mini: Eon Mini system 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
    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