Australia Issues Alert for Medtronic Deep Brain Stimulation Devices

Australia’s TGA and Medtronic Australasia have issued a hazard alert for five models of deep brain stimulation devices associated with potential loss of coordination in movement.

Deep brain stimulation devices are implantable, programmable devices that deliver electrical stimulation to the brain to treat the symptoms associated with movement disorders, including epilepsy and Parkinson’s disease.

The hazard alert cites a case report published in the Journal of Neurosurgery in May in which a patient lost coordination in the water and was unable to swim. Implanted deep brain stimulators may put patients at risk for drowning by causing temporary impairment.

Affected models include the Activa PC, SC and RC series, and the Kinetra 7428 and Soletra 7426.

Read the hazard alert here: www.fdanews.com/06-14-16-TGAMedtronicHazardAlert.pdf. — Joya Patel