Events

Rappel de Fortify, Fortify Assura, Quadra Assura, Unify, Unify Assura and Unify Quadra(Implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices)

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-2016-RN-01316-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-10-11
  • 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-2016-RN-01316-1
  • 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
    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.
  • Action
    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 ...
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Cardiovascular Devices
  • 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