Events

Rappel de Medtronic deep brain stimulation (DBS) devices Models :Activa PC 37601, Activa SC 37603, Activa RC 37612, Kinetra 7428, Soletra 7426

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medtronic Australasia 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-00702-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-06-06
  • 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-00702-1
  • 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
    Medtronic has become aware of a reported event of inability to swim following dbs implantation and initiation of dbs therapy for parkinson’s disease in a patient who was an experienced swimmer. information will be added in the future to medtronic’s deep brain stimulation (dbs) labelling in relation to loss of co-ordination, including the inability to swim.
  • Action
    Medtronic is advising surgeons and patients to be aware that loss of coordination may be a side effect of DBS therapy, and may result in, for example, the inability to swim. Patients should be made aware that participating in any activities requiring coordination that they were previously able to perform may place them in an unsafe situation; therefore these activities should be performed under supervision after DBS therapy is first turned on and after programming changes until any effects of their DBS therapy on coordination are understood. Medtronic is also updating the product labelling to include information in relation to the loss of coordination. For more information, please see https://www.tga.gov.au/alert/medtronic-deep-brain-stimulation-devices-multiple-models. This action has been closed-out on 16/02/2017.

Device

Medtronic deep brain stimulation (DBS) devices Models :Activa PC 37601, Activa SC 37603, Activa R...
  • Modèle / numéro de série
    Medtronic deep brain stimulation (DBS) devices Models :Activa PC 37601 (ARTG# 160118)Activa SC 37603 (ARTG# 188034)Activa RC 37612 (ARTG# 160117)Kinetra 7428 (ARTG# 134476)Soletra 7426 (ARTG# 134475)
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA