Events

Retiro De Equipo (Recall) de Nanostim Leadless Cardiac Pacemaker (LCP)

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-01460-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-11-24
  • 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-01460-1
  • 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) has identified that patients with nanostim leadless cardiac pacemakers may experience loss of telemetry and pacing due to battery malfunction. investigation by sjm found decreased battery capacity due to reduced electrolyte, resulting in high internal battery resistance. this disrupts the required capacity for proper device function and reduces device longevity. there have been seven (7) reports worldwide of lost telemetry and pacing output as a result of a battery malfunction. battery malfunction may be indicated with a loss of telemetry/communication with the implanted device and/or loss of pacing and magnet mode operation. these events occurred between 29 and 37 months post implant. no patient injuries have been reported in association with the loss of bradycardia pacing therapy.
  • Acción
    St Jude Medical has contacted the cardiologists who have implanted Nanostim leadless cardiac pacemakers providing further information about the above issue including patient management recommendations. They have been instructed to stop implanting these devices into new patients. For more information, please refer to https://www.tga.gov.au/alert/nanostim-leadless-cardiac-pacemaker . This action has been closed-out on 15/05/2017

Device

Nanostim Leadless Cardiac Pacemaker (LCP)
  • Modelo / Serial
    Nanostim Leadless Cardiac Pacemaker (LCP)Model Number: S1DLCP Supplied in Australia under Clinical Trial Notification (CTN) scheme
  • 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