Events

Retiro De Equipo (Recall) de Fortify, Fortify Assura, Quadra Assura, Unify, Unify Assura and Unify Quadra(Implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices)

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-2016-RN-01316-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-10-11
  • 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-2016-RN-01316-1
  • 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
    St. jude medical (sjm) is notifying physicians of the risk of premature battery depletion associated with their icds and crt-ds manufactured before may 23, 2015. high voltage icds and crt-ds that utilise lithium-based battery chemistries are subject to lithium cluster formation during high voltage charging. depending on their location, lithium clusters may cause a short circuit that can lead to premature battery depletion. if a short circuit occurs, battery depletion can occur in these devices within a day to a few weeks, which may result in the inability to deliver therapy.Among 398,740 devices sold worldwide, 841 devices returned for analysis due to premature battery depletion have had evidence of lithium material in the form of “clusters” in the battery. forty-six (46) exhibited visible clusters bridging the cathode and anode causing shorting. there have been 2 deaths that have been associated with the loss of defibrillation therapy as a result of premature battery depletion.
  • Acción
    SJM is contacting physicians to provide details regarding risk and patient management recommendations. Premature battery depletion can be identified by physicians through remote monitoring or in person visits showing ERI or more advanced battery depletion.Patients may become aware when their device reaches ERI because they may feel a vibratory patient notifier alert.SJM is providing recommendations that include confirming patients can feel and recognise vibratory alerts and reaffirming the availability and usage of remote monitoring to avoid or minimise time without device therapy for bradycardia and tachycardia events. Prophylactic device replacement is not recommended because complications following replacement have been reported to occur at a greater rate than the rate of harm associated with premature battery depletion. SJM is also notifying doctors not to implant any unused affected devices that they may have in their inventory.These devices will be replaced by unaffected stock. This action has been closed-out on 17/05/2017.

Device

Fortify, Fortify Assura, Quadra Assura, Unify, Unify Assura and Unify Quadra(Implantable cardiac ...
  • Modelo / Serial
    Fortify, Fortify Assura, Quadra Assura, Unify, Unify Assura and Unify Quadra(Implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices)Multiple model numbers
  • Clasificación del producto
    Cardiovascular Devices
  • 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