Events

Retiro De Equipo (Recall) de Device Recall Proclaim DRG Implantable Pulse Generator

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, 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
    79560
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1170-2018
  • Fecha de inicio del evento
    2018-03-09
  • Fecha de publicación del evento
    2018-03-23
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162647
  • 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
    Implantable pulse generator, programmer and battery charger - Product Code PMP
  • Causa
    The firm received complaints of error messages that occurred during routine impedance checks on proclaim drg ipgs, model 3664. some complaints were also associated with transient over stimulation which created discomfort for the patients.
  • Acción
    Notification material in the form of a Customer Letter was hand-delivered to two consignees in the US beginning 09 Mar 2018. The Physician Letter was hand-delivered to impacted implanting physicians, beginning 14 Mar 2018. A Patient Letter was delivered via certified mailing to all active implanted patients in the US, beginning 14 Mar 2018.

Device

Device Recall Proclaim DRG Implantable Pulse Generator
  • Modelo / Serial
    Lot Number 6210849 Serial Number AVM174.1  Lot Number 6210852 Serial Numbers: AVA560.1, AVA214.1, AVL027.1  Lot Number 6499208 Serial Numbers: AVD426.1, AVA922.1  Lot Number 6263128 Serial Numbers: AVB119.1, AVD400.1, AVA622.1, AVD431.1, AVE633.1,  AVK678.1, AVN837.1   Lot Number 6268723 Serial Numbers: AUV770.1, AVW805.1  Lot Number 6278155 Serial Number AVK896.1
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    US
  • Descripción del producto
    Proclaim DRG Implantable Pulse Generator, Model Number 3664
  • Manufacturer
    St. Jude Medical, Inc.

Manufacturer

St. Jude Medical, Inc.
  • Dirección del fabricante
    St. Jude Medical, 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