Events

Retiro De Equipo (Recall) de St. Jude Medical ICD/CRT-D devices programmed to a single VF detection zone with Merlin Programmer software version 17.2.2 rev. 0 Affected ICD/CRT-D devices: Current/Promote/AnalyST, Unify/Fortify, Assura and Ellipse families

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-2014-RN-00034-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-01-23
  • 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-2014-RN-00034-1
  • 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
    When using the merlin programmer with software version17.2.2 as part of a single vf detection zone configuration for icd/crt-d devices, the sinus redetection value will be inappropriately set to zero milliseconds. as a result, any intrinsic activity following the first shock will be considered a “sinus rate” and the device will diagnose “return to sinus”. therefore, if the arrhythmia was not terminated by the initial high voltage therapy, the ongoing arrhythmia would be considered a new episode causing the next high voltage therapy to also be delivered at the first programmed energy level. for example, if the first shock is programmed to 20 joules and subsequent shocks are programmed to higher energy values, the only hv therapy the patient would receive if the arrhythmia continues and is redetected, would be 20 joules, rather than the increasing hv energy levels as programmed.
  • Acción
    Clinicians are advised to review their SJM ICD/CRT-D patient records for patients with affected devices implanted or seen in clinic starting in September 2013 and programmed to a single VF detection zone with the 17.2.2 software. For patients identified during this review St. Jude is recommending to immediately schedule a follow-up visit. For patient devices programmed with 17.2.2 software, a new software version 17.2.3 will correct this issue and is expected to be available by February 2014. Using this software, programming any parameter will reset the return to sinus criteria to normal function. If a patient is seen before the 17.2.3 software is installed, then program the device to a two or three zone configuration, even if one of the zones is strictly a monitor zone. This will resolve the issue when using a programmer with 17.2.2 software. For more details, please see http://www.tga.gov.au/safety/alerts-device-st-jude-medical-icd-crtd-140128.htm . This action has been closed-out on 29/01/2016.

Device

St. Jude Medical ICD/CRT-D devices programmed to a single VF detection zone with Merlin Programme...
  • Modelo / Serial
    St. Jude Medical ICD/CRT-D devices programmed to a single VF detection zone with Merlin Programmer software version 17.2.2 rev. 0Affected ICD/CRT-D devices: Current/Promote/AnalyST, Unify/Fortify, Assura and Ellipse families Multiple ARTG numbers for ICD/CRT-D devicesARTG number for the Merlin Programmer: 124262
  • 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