Events

Rappel de RF enabled St. Jude Medical Ellipse, Fortify Assura, Unify Assura, and Quadra Assura Implantable Cardioverter Defibrillators (ICDs) and Assurity and Allure Pacemakers when used with Merlin@home RF Remote Monitoring Transmitter Model EX1150

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par St Jude Medical Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00756-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-08-20
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00756-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    A software anomaly has been identified in the merlin@home system that also has the potential to cause software resets for st. jude medical devices. despite the previous software upgrade, a low incidence of back up operation in some implanted st. jude medical devices with radio-frequency (rf) capability has been observed. this may occur as a result of a merlin@home transmitter initiating an implanted device software reset.This issue can only occur when the patient is being actively monitored by a merlin@home rf bedside transmitter.
  • Action
    Surgeons are advised that the majority of ICD and pacemaker devices are non-invasively restored by St. Jude Medical Technical Support over the air. However, in rare cases the device is unable to be restored and replacement may be required. St. Jude Medical has refined the software download procedure to reduce the incidence of failure. In the event a patient’s device reverts to back-up mode, St Jude Medical Australia recommends bringing the patient back in the clinic to clear the condition and return the device to full functionality. The Merlin@home transmitter software will be updated to prevent this issue from occurring. The software update will be performed automatically over the telephone, broadband or cellular connection .

Device

RF enabled St. Jude Medical Ellipse, Fortify Assura, Unify Assura, and Quadra Assura Implantable ...
  • Modèle / numéro de série
    RF enabled St. Jude Medical Ellipse, Fortify Assura, Unify Assura, and Quadra Assura Implantable Cardioverter Defibrillators (ICDs) and Assurity and Allure Pacemakers when used with Merlin@home RF Remote Monitoring Transmitter Model EX1150All model numbers affected ARTG Number (Merlin@home Remote Monitoring System): 161670
  • Manufacturer
    St Jude Medical Australia Pty Ltd

Manufacturer

St Jude Medical Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “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