Device Dossier
Vercise Charging System Kit Model DB-6412-EU-C - Battery charger
Device Dossier for Vercise Charging System Kit Model DB-6412-EU-C - Battery charger (Battery charger, Class III, sponsor Boston Scientific). ARTG record,…
- GMDN category: Battery charger
Intended purpose
A charging system used to charge an implantable pulse generator that provides: Unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal globus pallidus (GPi) for treatment of levodopa-responsive Parkinson's disease which is not adequately controlled with medication; Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) for treatment of intractable primary and secondary dystonia, for persons 7 years of age and older; Thalamic stimulation for the suppression of tremor not adequately controlled by medications in patients diagnosed with Essential Tremor. This kit contains a charger, base station, two charging collars, power supply and adaptor.
Functional description
The Charger is placed in a charging collar that is placed round the patients neck so that the charger is positioned over the stimulator implanted under the clavicle. The charger is then able to charge the rechargeable battery within the IPG. The base station is designed to remain connected to a power outlet at all times. When it is not being used, the charger is to remain on the base station so that it is ready to deliver a charge