Events

Rappel de ISOLINE 2CR6 and 2CT6 Implantable Defibrillation Leads

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Sorin Group Australia.

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-2013-RN-00088-2
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-01-31
  • 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-2013-RN-00088-2
  • 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
    As of december 31, 2012, 30 cases of internal insulation breach under the rv or svc defibrillation coil have been confirmed by the analysis conducted on returned products. in each of the 30 identified cases, the internal insulation breach of the silicone lumen was observed under the rv and/or svc defibrillation coil, i.E. where the microcables are not coated with etfe, resulting in a contact between the conductors, thus leading to low pacing impedance and/or ventricular oversensing, and/or inappropriate therapy. it should be noted that in case of ventricular oversensing, pacing is inhibited.
  • Action
    Sorin Group Australia is issuing a 'Hazard Alert' letter to implanting/ treating clinicians and hospitals detailing the issues and how to manage the affected patients. The TGA has published a web statement regarding the issues. For more information, please see http://www.tga.gov.au/safety/alerts-device-isoline-leads-130306.htm .

Device

ISOLINE 2CR6 and 2CT6 Implantable Defibrillation Leads
  • Modèle / numéro de série
    ISOLINE 2CR6 and 2CT6 Implantable Defibrillation LeadsPrevious ARTG numbers (cancelled in Nov 2011) : 165673, 165674Multiple serial numbers
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Sorin Group Australia

Manufacturer

Sorin Group Australia