Events

Recall of Spinal Cord Stimulation Neurostimulators, Spinal Cord Stimulation Leads, Kits and Patient Programmers

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-2014-RN-00288-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-03-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00288-1
  • 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
    Post market review by medtronic has identified that there is the potential for patients to experience spinal cord compression weeks to years after implant of a spinal cord stimulation lead. spinal cord compression can lead to neurological deficit due to the formation of reactive tissue, sometimes with an inflammatory component. the time to onset for spinal cord compression ranges from weeks to over 17 years, and may progress after lead removal.
  • Action
    Medtronic is advising surgeons that prophylactic removal of the leads is not recommended. Awareness of this adverse event can lead to early detection and prevention of permanent neurological impairment. If a patient presents with new neurological deficit, spinal cord compression due to reactive tissue mass formation should be considered as a potential cause. For more details, please see http://www.tga.gov.au/safety/alerts-device-medtronic-spinal-cord-140317.htm .

Device

Spinal Cord Stimulation Neurostimulators, Spinal Cord Stimulation Leads, Kits and Patient Program...
  • Model / Serial
    Spinal Cord Stimulation Neurostimulators, Spinal Cord Stimulation Leads, Kits and Patient ProgrammersMultiple model numbers affectedARTG Numbers: 141860, 154866, 141861, 177594, 215751, 215748, 215749, 215750, 143034, 141857, 137079, 123240, 123242, 137080, 123241, 123243, 214838, 214839, 137348, 143035, 141858, 114947, 119320, 163895, 148397, 219258, 219259, 134080, 137439, 139649, 177036 and 214421
  • 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