Events

Recall of Activa PC, Activa RC and Activa SC Implantable Deep Brain Stimulators and RestoreUltra and RestoreSensor Implantable 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-00041-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-01-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00041-1
  • 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
    1) unexpected loss of stimulation may occur under the following conditions:- switching from a group with two programs to a group with three or four programs where a non-negative contact is shared within the programmed groups. - creating program groups (activa sc only) when a second program is created for the first time.2) under a specific set of conditions (activa sc – models 37602 / 37603 are not affected), typically related to device recovery from an over discharge, there is a potential for over stimulation or stimulation directed to a lead electrode other than what was intended:- device reaches a power on reset (por) state. a por may be detected during interrogation with the patient or physician programmer. the patient will experience loss of therapy if a por occurs.- ‘therapy off’ command is sent (by patient programmer, insr, or ‘therapy-stop’ button on the 8840 clinician programmer) to device while the device is making an automatic periodic battery measurement.
  • Action
    Medtronic does not recommend prophylactic explant of devices because these issues can be addressed non-invasively by the clinician using an 8840 clinician programmer or an Implantable Neurostimulator Recharger using the Physician Recharge Mode. The model 8870 software application card used by the programmer is being updated to version BBR01A by Medtronic field representative. Interrogating patient’s device with the updated software version will automatically update the implanted device software and reduce the probability that a loss of stimulation output will occur. To significantly reduce the likelihood of over stimulation or stimulation in the wrong area, patients should avoid over discharge. For more details, please see http://www.tga.gov.au/safety/alerts-device-medtronic-deep-brain-spinal-cord-stimulation-devices-140204.htm . Thia action has been closed-out on 28/01/2016.

Device

Activa PC, Activa RC and Activa SC Implantable Deep Brain Stimulators and RestoreUltra and Restor...
  • Model / Serial
    Activa PC, Activa RC and Activa SC Implantable Deep Brain Stimulators and RestoreUltra and RestoreSensor Implantable Spinal Cord StimulatorsActiva PC, Activa RC and Activa SC Implantable Deep Brain StimulatorsModel Numbers: 37601, 37602, 37603, 37612ARTG Numbers: 160118, 188274, 188034, 160117 RestoreUltra and RestoreSensor Implantable Spinal Cord StimulatorsModel Numbers: 37712, 37714ARTG Numbers: 154866, 177594
  • 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