Consumers and health professionals are advised that Medtronic Australasia, in consultation with the TGA, has issued a hazard alert regarding multiple models of its neurostimulation devices, including those used for deep brain, spinal cord and peripheral nerve stimulation therapies. Medtronic Australasia is also undertaking a recall for product correction to update the instructions for use.
Neurostimulation devices are implantable, programmable medical devices that deliver electrical stimulation to specific parts of the patient's brain, spinal cord or peripheral nervous system to help treat various conditions, including chronic pain, movement disorders, epilepsy and Parkinson's disease.
Fig. 1 - Neurostimulation device used for deep brain stimulation therapy
Fig. 2 - Neurostimulation device used for spinal cord and peripheral nerve stimulation therapies
It has been identified that enabling the cycling feature in certain models of Medtronic neurostimulation devices (see below for a list of affected models) may lead to premature battery depletion.
Since 2005, Medtronic has received four reports of this issue worldwide, all of which were associated with spinal cord stimulation therapy.
If premature battery depletion occurs, the patient may have to undergo surgery earlier than would normally be expected to address the issue.
Medtronic Australasia is updating the labelling for affected devices and is providing updated calculations and graphs to assist health professionals to assess the impact of cycling on device longevity.
Information for consumers
Medtronic Australasia has written to health professionals who have implanted affected neurostimulator models, or are managing patients who have these devices, providing further information.
If you have a neurostimulation device used for deep brain, spinal cord or peripheral nerve stimulation therapies, but do not use the cycling feature, you are not affected by this issue.
If your neurostimulation device uses the cycling feature, continue to check your battery status as normal. Instructions on how to check battery status can be found in the patient programmer or recharger system manual.
If you have any questions or concerns regarding this issue, contact your managing health professional.
Information for all health professionals
If you are treating a patient who has a neurostimulation device used for deep brain, spinal cord or peripheral nerve stimulation therapies, and they have any questions or concerns about this issue, refer them to their managing surgeon or neurologist.
Information for surgeons and neurologists
Medtronic Australasia has written to surgeons and neurologists who have implanted affected neurostimulator models, or are managing patients who have these devices, providing further information.
At their next scheduled visit, advise patients of this issue and remind them to continue checking their battery status as normal. Instructions on how to check battery status can be found in the patient programmer or recharger system manual.
If you have patients with cycling enabled, or you wish to use cycling, use the updated calculations and graphs provided by Medtronic Australasia to assess the impact of cycling on device longevity.
For pain stimulation trialling only, the cycling feature should not be enabled on the external neurostimulator when estimating device longevity, as the result for non-rechargeable devices may not provide accurate information on the N'Vision Clinician Programmer. However, the Elective Replacement Indicator (ERI) and End of Service (EOS) notifications will occur accurately, as designed, when interrogated by the patient programmer, recharger and/or N'Vision Clinician Programmer.
Medtronic Australasia will update the labelling for affected devices in the second half of 2014. In the meantime, the updated calculations and graphs are available in the professional area of the Medtronic website.
If you have any questions or concerns regarding this issue, contact Medtronic Australasia customer service on 1800 668 670.
Below are lists of deep brain stimulation and spinal cord stimulation devices for which the adverse event labelling will be updated.
Deep brain stimulation and spinal cord stimulation devices and model numbers:
- Activa PC - 37601
- Activa SC - 37602
- Activa SC - 37603
- Activa RC - 37612
- PrimeAdvanced - 37702
- RestoreUltra - 37712
- RestoreAdvanced - 37713
- RestoreSensor - 37714
- PrimeAdvanced SureScan MRI - 97702
- RestoreUltra SureScan MRI - 97712
- RestoreAdvanced SureScan MRI - 97713
- RestoreSensor SureScan MRI - 97714.
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.