Events

Recall of RestoreSensor Implantable Neurostimulators

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-00521-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-05-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00521-1
  • 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 confirmed 4 instances of loss of therapy during the recharging of a restoresensor implantable neurostimulator, at a rate of 0.007% worldwide. by design, stimulation therapy turns off when the battery voltage depletes below 3.575 volts (< 0% battery level). insufficient coupling (charging efficiency) between the recharger & the implant during the recharge session was found to be a key factor in the reported events which consequently led to the inadequate recharge of the battery & subsequent loss of stimulation therapy. if the insufficient recharge coupling is continued & the battery is not recharged to restart stimulation therapy, the battery can discharge to an over discharge (od) state. under normal use conditions, the patient has 30 days to recharge the device to avoid experiencing a battery od state. in this scenario, this time period is reduced to 1–2 days. if three occurrences of od occur, the implant will trigger end of life, and must be replaced to restore therapy.
  • Action
    Medtronic advises patients to follow the current recharge instructions, paying particular attention to Charging Efficiency and Battery Charge Level indicators on the recharger, specifically: - Check the neurostimulator battery charge level once a day or more frequently as needed. - Keep the neurostimulator sufficiently charged to maintain therapy. It can be charged at any time; users do not need to wait for a low battery message. - During neurostimulator recharging, monitor the Charging Efficiency row and adjust the antenna to obtain as many solid black boxes as possible. If only two boxes are filled in (6 or more boxes are empty) adjust the antenna to improve the signal strength between the neurostimulator and recharger. - During recharging, ensure the neurostimulator Battery Charge Level is at least 25% before ending the charge session. However, a full battery charge is ideal. - Medtronic is working with the TGA to assess the best approach to resolve the reported issue. This action has been closed-out on 02/03/2017.

Device

RestoreSensor Implantable Neurostimulators
  • Model / Serial
    RestoreSensor Implantable NeurostimulatorsModel Numbers: 37714, 97714ARTG Numbers: 177594, 215750
  • 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