Events

Recall of Brain and Spinal Cord Stimulators

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-00289-1
  • 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-00289-1
  • 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
    Cycling is a programmable feature which allows the stimulation output of a device to toggle on and off based on programmed settings. enabling cycling at certain parameter settings may decrease the recharge interval for rechargeable devices and the device longevity.In may 2012, the first two cases of premature battery depletion where cycling was programmed at fast rates (0.1s on/off) in conjunction with low patient amplitudes (<3 volts) were reported. both of these reports involved the primeadvanced device model 37702. both devices were explanted, returned and analysed. this inspection, engineering bench testing, and detailed understanding of how the patients used these devices confirmed that specific patient therapy parameters in conjunction with cycling being enabled resulted in a higher current drain on the battery when compared to running the device in continuous mode. higher current drain results in reduced battery longevity.
  • Action
    Surgeons are advised that the updated calculations and graphs available at professional.medtronic.com/cycling to assess the affect of cycling on device longevity. Surgeons are requested to remind their patients to continue to check battery status. For more details, please see http://www.tga.gov.au/safety/alerts-device-medtronic-neurostimulation-140317.htm .

Device

Brain and Spinal Cord Stimulators
  • Model / Serial
    Brain and Spinal Cord StimulatorsMultiple model numbers affectedARTG Numbers: 160118, 160117, 188274, 188034, 141861, 154866, 177594, 141860, 215748, 215749, 215750 and 215751
  • Product Classification
    Neurological Devices
  • 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