Medtronic Australasia, in consultation with Australia’s Therapeutic Goods Administration (TGA), has issued a safety warning for InterStim and InterStim II neurostimulation devices, because of possible early depletion of the battery. Medtronic Australasia is 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 treat conditions including overactive bladder, urinary retention and fecal incontinence.
According to the TGA, Australia’s drug and medical device regulatory agency, enabling the cycling feature in InterStim (model 3023) and InterStim II (model 3058) neurostimulation devices may lead to premature battery depletion. If such depletion occurs, the patient may need to undergo surgery earlier than would normally be expected to address the issue.
Medtronic Australasia is updating the devices’ labeling and is providing new information to assist health professionals manage patients who are receive sacral nerve stimulation using these devices. The TGA says that as of January 27, 2015, no patients in Australia have reported problems as a result of the battery issue.
Medtronic Australasia has sent a letter to written to surgeons who have implanted InterStim and InterStim II neurostimulation devices and doctors who are caring for patients who have these devices, providing further information. The TGA says that if a patient does not use the cycling feature of the InterStim or InterStim II device, this issue does not affect the patient. The TGA advises patients who use the cycling feature to regularly check the battery status according to instructions found in the patient programmer or recharger system manual.