Events

Rappel de COGNIS Implantable Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and TELIGEN DR & VR Implantable Cardioverter -Defibrillators (ICDs)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Boston Scientific 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-2014-RN-01011-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-09-22
  • 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-2014-RN-01011-1
  • 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
    This is an update to the august 2013 physician communication (tga ref.: rc-2013-rn-00906-1). the performance of an lv capacitor may be compromised in some devices after two or more years of implant time, which will increase battery use and may eventually initiate one or more safety architecture alerts and patient-audible beeping. the most common alert is a yellow programmer screen that states, “voltage is too low for projected remaining capacity. contact technical services with code 1003”. latitude issues a corresponding yellow alert (nominally configured “on”). in other instances, diminished lv capacitor performance can result in an early “explant” battery status indicator (eri) and a replacement window that may be less than 3 months. boston scientific has identified a second subset of devices that may exhibit a similar issue. no patient deaths have been associated with this issue. affected devices have not been available for implant for more than three years.
  • Action
    Boston Scientific has recently introduced updated software that will further improve Safety Architecture effectiveness. Boston scientific recommend that patients with a device in the affected population be scheduled for an in-clinic visit to upgrade their device with this new software. After a device has been upgraded, continue normal device monitoring as directed within labelling, and promptly investigate all alerts and device beeping. Devices that experience a low voltage alert require replacement. If not replaced, increased current drain could deplete the battery and impact therapy delivery and telemetry. If a Safety Architecture alert is observed, Boston Scientific Technical Services can analyse device information downloaded from a recent in-clinic or LATITUDE interrogation, which will clarify approximately how much time is available to replace the device. Fro more details, please see http://www.tga.gov.au/safety/alerts-device-cognis-crt-d-and-teligen-icd-130924.htm . This action has been closed-out on 07/07/2016.

Device

COGNIS Implantable Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and TELIGEN DR & VR ...
  • Modèle / numéro de série
    COGNIS Implantable Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and TELIGEN DR & VR Implantable Cardioverter -Defibrillators (ICDs)Affected model numbers: COGNIS CRT-D : N106/N107/N108/N118/N119/N120/P106/P107/P108TELIGEN DR ICD:E110/E111/F110/F111TELIGEN VR ICD: E102/E103/F102/F103Devices manufactured prior to March of 2010.ARTG Numbers: 154039, 154037, 154034, 154033, 154035, 154038, 154036
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty Ltd
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DHTGA