Events

Rappel de Medtronic Activa PC, Activa SC, Activa RC, Kinetra and Soletra Implantable Deep Brain Stimulators (DBS)

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-2015-RN-00673-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-07-21
  • 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-00673-1
  • 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’s monitoring of reported events, clinical trials and published literature has resulted in labelling updates: warnings:- severe, life-threatening dystonia symptoms, including status dystonicus, during ongoing or loss of therapy may result in respiratory compromise and rhabdomyolysis. rarely, rhabdomyolysis may progress to multi-organ failure & death. - cessation or reduction of stimulation may lead to an increase in seizure frequency or severity of epilepsy. symptoms may return with an intensity greater than was experienced prior to system implant, including the potential for status epilepticus. adverse events: - meningitis, encephalitis or brain abscess resulting from infection - focal oedema to the area around the lead- immediate or delayed intracranial haemorrhage or cerebral infarction which could be symptomatic, or which could result in temporary or permanent neurological injury or death- aseptic intraparenchymal cyst formation around the lead tip.
  • Action
    The labelling updates further clarify potential risks which have been reported with DBS Therapy. Medtronic is providing the information about the labelling updates to help physicians who are implanting and managing patients to give them visibility into the upcoming changes for labelling and help them with management of their current patients treated with DBS Therapy. Regarding DBS Therapy for Dystonia, physicians are advised to monitor patients receiving DBS Therapy for the above symptoms and emphasise the importance of contacting the physicians if patients experience worsening of seizure frequency or severity. Regarding DBS Therapy for epilepsy, it is important that the patient or caregiver knows how to use the patient programmer in case the neurostimulator is accidentally turned off . This action has been closed-out on 15/08/2016.

Device

Medtronic Activa PC, Activa SC, Activa RC, Kinetra and Soletra Implantable Deep Brain Stimulators...
  • Modèle / numéro de série
    Medtronic Activa PC, Activa SC, Activa RC, Kinetra and Soletra Implantable Deep Brain Stimulators (DBS)Activa PC Model Number: 37601ARTG Number: 160118Activa SC Model Number: 37603 and 37602ARTG Number: 188034Activa RC Model Number: 37612ARTG Number: 160117Kinetra Model Number: 7428ARTG Number: 134476SoletraModel Number: 7426ARTG Number: 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