Advanced Neuromodulation Systems Inc. - Brio DBS System - Class 2 Recall

The Brio DBS System consists of a rechargeable implantable neurostimulator, also referred to as IPG or R-IPG, which is used with four-electrode leads and extensions of various lengths and is programmed by an external programmer. The IPG can also be controlled by a patient controller and is recharged by a portable charger. This system is designed to deliver electrical stimulation in various combinations of amplitude, pulse width, and frequency to specific targets in the brain. The IPG, leads, and extensions comprise the implantable components of the Brio DBS System. Brio" DBS IPG Model 6788 Implantable Pulse Generator (IPG) is a dual channel, (16) sixteen-contact receiver designed to be connected to a four-electrode lead or a lead extension. The IPG is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant current electrical stimulation. The IPG kit contains 1B1 BrioPG, 1 pocket sizer, 2 port plugs, and a torque wrench. The Brio Rechargeable Neurostimulation System has the same hardware as Eon Mini IPG. Brio" Implantable Pulse Generator Specifications: Model: 6788 Dimensions: 48 mm (1.89 ) x 53 mm (2.09 ) x 9.5 to 11 mm (0.37 to 0.43 ) Weight: 29 grams (1.0 oz) Volume: 17.7 cm3 (1.08 in3) Power Source: Rechargeable Lithium-ion Cell Product is indicated for use in unilateral or bilateral stimulation of the thalamus, including the internal globus pallidus (GPi) or subthalmic nucleus (STN) in patients w...
Source: Medical Device Recalls - Category: Medical Equipment Source Type: alerts