March 1, 2014 | Australia’s Therapeutic Goods Administration earlier this month posted a notice that, in conjunction with Medtronic Australasia, it has issued a hazard alert for several models of Medtronic neuromodulation devices, including some Activa deep brain stimulation devices and RestoreUltra and RestoreSensor spinal cord stimulation devices. Medtronic Australasia announced it is undertaking a recall for product correction to address problems with the devices.
The alert cited two issues that have been identified with these devices. The first issue is the potential for loss of stimulation—patients may experience unexpected loss of stimulation under certain conditions. The second issue is the potential for over-stimulation or stimulation in the wrong area.
Medtronic said it would address the loss of stimulation issue by updating the software of the programmer device, which will correct the problems at the patient’s next scheduled visit. This programmer device is used by health professionals and Medtronic representatives, and is distinct from patient programmers that some patients may have. Also, if patients avoid over-discharge of their device, the likelihood of the over-stimulation or stimulation in the wrong area issue occurring will be significantly reduced.
There have been no reports of deaths or life-threatening injuries associated with these issues worldwide.
