Events

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

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medtronic Australasia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00673-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-07-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00673-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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...
  • Model / Serial
    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
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “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