Events

Recall of Medtronic Deep Brain Stimulation (DBS) Extension

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-00704-1
  • 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-00704-1
  • 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 identified the following serious events or injuries associated with tunnelling that are not presented in the current dbs labelling. the following events are associated with the dbs implant and tunnelling the extension from the lead to the ins:- cases of spinal accessory nerve injury- severe bleeding or vascular injury- an extension inadvertently implanted through the ribs and was later found to be close to the heart requiring revision- tunnelling too superficially resulting in an extension that exited and then re-entered the neck which wasn’t discovered until the surgical drape was removedthese events occurred in an estimated 0.008% of tunnelling procedures.
  • Action
    Medtronic is sharing this information to help surgeons with the DBS implant procedure, patient selection, informed consent, and post-implant follow- up for patients treated with DBS Therapy. Surgeons are advised that during the DBS implant, use caution while tunnelling the extension from the lead to the INS to avoid tunnelling too deeply or superficially because serious injury may occur. In the immediate post-operative period, surgeons are advised to monitor patients for signs and symptoms of potential complications or adverse effects related to the tunnelling procedure. Information will be added to Medtronic's Deep Brain Stimulation (DBS) labelling. For more details, please see https://www.tga.gov.au/alert/medtronic-deep-brain-stimulation-therapy-dbs-extension-models-7483-and-37086 . This action has been closed-out on 20/01/2017.

Device

Medtronic Deep Brain Stimulation (DBS) Extension
  • Model / Serial
    Medtronic Deep Brain Stimulation (DBS) Extension Models 7483 and 37086 ARTG Number: 239412
  • 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