Device Dossier
Proclaim XR 7 Implantable Pulse Generator model 3662 - Analgesic spinal cord electrical stimulation system pulse generator implantable
Device Dossier for Proclaim XR 7 Implantable Pulse Generator model 3662 - Analgesic spinal cord electrical stimulation system pulse generator implantable…
Intended purpose
The neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. The system is intended to be used with leads and associated extensions that are compatible with the system. This neurostimulation system is indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain. The device model 3662 is MR conditional.
Functional description
The IPG is designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers & controllers.