Australia Recalls Medtronic InterStim Neurostimulation DevicesFeb 9, 2015
The Therapeutic Goods Administration (TGA), Australia’s drug and medical device regulatory agency, in consultation with Medtronic Australasia, has issued a safety alert for InterStim and InterStim II neurostimulation devices, which are used for sacral nerve stimulation therapies. Medtronic Australasia is also undertaking a recall for product correction to update the instructions for use.
InterStim and InterStim II neurostimulation devices are implantable, programmable medical devices that deliver electrical stimulation to sacral nerves to help treat various conditions, including overactive bladder, urinary retention and fecal incontinence.
According to the TGA, enabling the cycling feature in InterStim (model 3023) and InterStim II (model 3058) neurostimulation devices may lead to premature battery depletion. 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 labeling for affected devices and is providing updated information to assist health professionals manage patients who are receiving sacral nerve stimulation using these devices. As of January 27, 2015, there have been no reports in Australia of patients experiencing problems as a result of this issue.
Medtronic Australasia has written to health professionals who have implanted InterStim and InterStim II neurostimulation devices, or are managing patients who have these devices, providing further information. Patients who do not use the cycling feature of the InterStim or InterStim II device are not affected by this issue. The TGA advises recipients who use the cycling feature to continue to check the battery status as normal. Instructions on how to check battery status can be found in the patient programmer or recharger system manual.