Medtronic Australasia, in consultation with Australia’s Therapeutic Good Administration, issued a hazard alert for two models of its Neuromodulation Deep Brain Stimulation system pocket adaptors in Australia.
The pocket adaptors (model numbers 64001 and 64002) are used with Activa PC and Activa RC neurostimulators.
Globally, 16 Medtronic Neuromodulation DBS system pocket adaptors have been returned due to high impedance, resulting in decreased current being conducted through the device.
Some of the reported cases involved loss of therapy, return of symptoms, rebound effects and potential revision surgery to replace the device. There have been no incidents reported in Australia.
Analysis of the returned devices found the cause of the high impedance to be conductor wire fractures near where the wire exits the neurostimulator connector block.
In two cases, the issue was identified during implantation surgery, while the other 14 were identified after implantation and resulted in revision surgery.
DBS devices are implantable, programmable devices that deliver electrical stimulation to the patient’s brain. The devices are used to treat symptoms associated with movement disorders such as epilepsy and Parkinson’s disease.