St Jude Medical implantable neurostimulators and accessories – various devices
Hazard alert - devices should no longer be used to treat migraine
Consumers and health professionals are advised that occipital nerve stimulation for the treatment of chronic intractable migraine is no longer an approved use for certain St Jude Medical implantable neurostimulator devices and its accessories.
Occipital nerve stimulation is one type of peripheral nerve stimulation, a treatment technique in which small electrical currents are applied to parts of the nervous system to treat chronic pain. Occipital nerve stimulation applies electrical currents to a part of the nervous system at the base of the skull and has been used to treat chronic, intractable migraines.
The TGA has classified this change as a hazard alert to inform consumers and health professionals of the changed advice relating to St Jude Medical’s occipital nerve stimulation devices and the latest data relating to their use.
St Jude Medical Australia Pty Ltd has supplied a range of implantable pulse generators and leads that are used for peripheral nerve stimulation.
St Jude Medical removed chronic, intractable migraine as an indication for these devices after data from the post-market clinical follow-up did not show the same level of benefit as the pivotal study and showed similar rates of serious adverse outcomes, such as lead migration, requiring further surgical intervention. St Jude Medical has formally applied to the TGA to remove this indication for the use of its products from the Australian Register of Therapeutic Goods.
The company has not changed the advice regarding the use of its products for other indications such as the management of chronic, intractable pain of the trunk and limbs.
The models affected by this alert are:
- Eon/Eon C/Eon Mini Neurostimulation System
- Prodigy Neurostimulation System
- Octrode and Quattrode percutaneous leads.
Information for consumers
If you, or someone you care for, has a St Jude Medical device implanted for occipital nerve stimulation therapy be aware of this issue.
If you are experiencing no problems you should maintain your prearranged follow-up program with your treating health professional.
If you are experiencing issues you should seek advice promptly from your treating health professional.
Information for health professionals
If you are involved with the implantation of St Jude neurostimulators, be aware of the change to product indications. St Jude is not recommending a change in the way currently implanted patients are followed up.
If you are treating a patient who is using one of these devices for the indication of chronic intractable migraine you should continue to be mindful of the need to balance the risks versus benefits. TGA's review of St Jude Medical's clinical evidence for the treatment of migraine through occipital nerve stimulation identified a high rate of adverse events in both the pivotal study and from the post-market study (PMCF) and the complaints received by the manufacturer. Lead migration requiring surgical intervention occurs consistently at around 4%. In the PMCF the number of headache-free days, as well as other outcome measures, was lower than in the pivotal study.
These products are still available for use as an aid in the management of chronic, intractable pain of the trunk and/or limbs.
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.