Events

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

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-2016-RN-00702-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-06-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00702-1
  • 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 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...
  • Model / Serial
    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
  • 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