Events

Retiro De Equipo (Recall) de Brio Charging System Model 6721 (used with Deep Brain Stimulator, Brio IPG Model 65-6788)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por St Jude Medical Australia Pty Ltd.

¿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
    RC-2015-RN-00920-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-09-15
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00920-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Some patients have reported experiencing an uncomfortable temperature increase at the implantable pulse generator (ipg) implant site during charging, with a small number of patients reporting burns at the implant site. this matter is a follow-up to a hazard alert letter issued by st. jude medical (sjm) in august 2012 (tga reference: rc-2012-rn-00759-3).In the august 2012 letter, st. jude medical informed customers that they would be implementing design improvements to the charger to address the possibility of increased energy dissipation during charging. the new brio le charging system model 6722 and brio le charger accessory model 6720 reduces the potential for uncomfortable temperature increases that may be felt near the ipg while recharging, by automatically turning the energy it delivers on and off. this will require patients to either charge for longer or more frequently to achieve a full charge.
  • Acción
    St. Jude Medical recommends the prompt replacement of the charger for patients who have reported excessive heating during charging. For other patients, replacement of the charger is recommended at the next follow-up. Upon replacement, proper charging function of the Brio LE Charger Accessory Model 6720 must be confirmed. The Brio LE Charger System Model 6722 and Brio LE Charger Accessory Model 6720 may not be able to charge implanted IPGs at an implant depth greater than 2.25cm (the Model 6721 was labelled for implant depth up to 2.50 cm). In case of difficulties with the charging function of the Brio LE Charger Accessory Model 6720 due to the depth of the implant, patients should continue to use their current Brio Charger Model 6721, following the precautions provided in the August 2012 letter.

Device

Brio Charging System Model 6721 (used with Deep Brain Stimulator, Brio IPG Model 65-6788)
  • Modelo / Serial
    Brio Charging System Model 6721 (used with Deep Brain Stimulator, Brio IPG Model 65-6788)ARTG Number: 164512
  • Manufacturer
    St Jude Medical Australia Pty Ltd

Manufacturer

St Jude Medical Australia Pty Ltd
  • 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
    DHTGA