Electrical stimulation systems

Percept™ RC neurostimulator with BrainSense™ technology

<p>Percept™ RC is a rechargeable neurostimulator with sensing, directionality, and advanced programming capabilities for deep brain stimulation (DBS).</p>

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Indications, Safety, and WarningsMedtronic DBS therapy for Parkinson‘s disease, tremor, dystonia, and epilepsyProduct labeling must be reviewed prior to use for detailed disclosure of risks.IndicationsMedtronic DBS therapy for Parkinson‘s diseaseBilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS therapy for Parkinson‘s disease is indicated for adjunctive therapy in reducing some of the symptoms in individuals with levodopa-responsive Parkinson‘s disease of at least four year’s duration that are not adequately controlled with medication, including motor complications of recent onset (from four months to three years) or motor complications of longer-standing duration.Medtronic DBS therapy for tremorUnilateral thalamic stimulation of the ventral intermediate nucleus (VIM) using Medtronic DBS therapy for tremor is indicated for the suppression of tremor in the upper extremity. The system is intended for use in patients who are diagnosed with essential tremor or parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability.Medtronic DBS therapy for dystonia*Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) using Medtronic DBS therapy for dystonia is indicated as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis), in patients seven years of age or above.Medtronic DBS therapy for epilepsyBilateral stimulation of the anterior nucleus of the thalamus (ANT) using the Medtronic DBS system for epilepsy is indicated as an adjunctive therapy for reducing the frequency of seizures in individuals 18 years of age or older diagnosed with epilepsy characterized by partial-onset seizures, with or without secondary generalization, that are refractory to three or more antiepileptic medications.The Medtronic DBS system for epilepsy has demonstrated safety and effectiveness for patients who average six or more seizures per month over the three most recent months prior to implant of the DBS system (with no more than 30 days between seizures). The Medtronic DBS system for epilepsy has not been evaluated in patients with less frequent seizures.ContraindicationsMedtronic DBS therapy is contraindicated for patients who are unable to properly operate the neurostimulator and, for Parkinson‘s disease and essential tremor, patients for whom test stimulation is unsuccessful. The following procedures are contraindicated for patients with DBS systems: diathermy (e.g., shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy), which can cause neurostimulation system or tissue damage and can result in severe injury or death; transcranial magnetic stimulation (TMS); and certain MRI procedures using a full body transmit radio-frequency (RF) coil, a receive-only head coil, or a head transmit coil that extends over the chest area if they have an implanted Soletra™ Model 7426 neurostimulator, Kinetra™ Model 7428 neurostimulator, Activa™ SC Model 37602 neurostimulator, or Model 64001 or 64002 pocket adaptor.WarningsThere is a potential risk of brain tissue damage using stimulation parameter settings of high amplitudes and wide pulse widths and, for Parkinson‘s disease and essential tremor, a potential risk to drive tremor (cause tremor to occur at the same frequency as the programmed frequency) using low frequency settings. Extreme care should be used with lead implantation in patients with an increased risk of intracranial hemorrhage. Sources of electromagnetic interference (EMI) may cause device damage or patient injury. Theft detectors and security screening devices may cause stimulation to switch on or off and may cause some patients to experience a momentary increase in perceived stimulation. The DBS system may be affected by or adversely affect medical equipment such as implanted cardiac devices (e.g., pacemaker, defibrillator), external defibrillation/cardioversion, ultrasonic equipment, electrocautery, or radiation therapy. MRI conditions that may cause excessive heating at the lead electrodes which can result in serious and permanent injury including coma, paralysis, or death, or that may cause device damage, include neurostimulator implant location other than pectoral and abdominal regions; unapproved MRI parameters; partial system explants (“abandoned systems”); misidentification of neurostimulator model numbers; and broken conductor wires (in the lead, extension or pocket adaptor). The safety of electroconvulsive therapy (ECT) in patients receiving DBS therapy has not been established. Abrupt cessation of stimulation should be avoided as it may cause a return of disease symptoms, in some cases with intensity greater than was experienced prior to system implant (“rebound” effect). Onset of status dystonicus, which may be life-threatening, may occur in dystonia patients during ongoing or loss of DBS therapy.For epilepsy, cessation, reduction, or initiation of stimulation may potentially lead to an increase in seizure frequency, severity, and new types of seizures. For epilepsy, symptoms may return with an intensity greater than was experienced prior to system implant, including the potential for status epilepticus. For Parkinson‘s disease or essential tremor, new onset or worsening depression, suicidal ideation, suicide attempts, and suicide have been reported. For dystonia or epilepsy, depression, suicidal ideations, and suicide have been reported, although no direct cause-and-effect relationship has been established. For epilepsy, preoperatively, assess patients for depression and carefully balance this risk with the potential clinical benefit. Postoperatively, monitor patients closely for new or changing symptoms of depression and manage these systems appropriately. Patients should be monitored for memory impairment. Memory impairment has been reported in patients receiving Medtronic DBS therapy for epilepsy, although no direct cause-and-effect relationship has been established. The consequences of failing to monitor patients are unknown. When stimulation is adjusted, monitor patients for new or increased seizures, tingling sensation, change in mood, or confusion.Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement that may result in loss of stimulation, intermittent stimulation, stimulation at the fracture site, and additional surgery to replace or reposition the component. Patients should avoid manipulating the implanted system components or burr hole site as this can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Patients should not dive below 10 meters (33 feet) of water or enter hyperbaric chambers above 2.0 atmospheres absolute (ATA) as this could damage the neurostimulation system, before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their clinician.Patients using a rechargeable neurostimulator must not place the recharger over a medical device with which it is not compatible (e.g., other neurostimulators, pacemakers, defibrillator, insulin pumps). The recharger could accidentally change the operation of the medical device, which could result in a medical emergency. Patients should not use the recharger on an unhealed wound as the recharger system is not sterile and contact with the wound may cause an infection.PrecautionsLoss of coordination in activities such as swimming may occur. Patients using a rechargeable neurostimulator should check for skin irritation or redness near the neurostimulator during or after recharging, and contact their physician if symptoms persist.Adverse eventsAdverse events related to the therapy, device, or procedure can include intracranial hemorrhage, cerebral infarction, CSF leak, pneumocephalus, seizures, surgical site complications (including pain, infection, dehiscence, erosion, seroma, and hematoma), meningitis, encephalitis, brain abscess, cerebral edema, aseptic cyst formation, device complications (including lead fracture and device migration) that may require revision or explant, extension fibrosis (tightening or bowstringing), new or exacerbation of neurological symptoms (including vision disorders, speech and swallowing disorders, motor coordination and balance disorders, sensory disturbances, cognitive impairment, and sleep disorders), psychiatric and behavioral disorders (including psychosis and abnormal thinking), cough, shocking or jolting sensation, ineffective therapy, and weight gain or loss.For Parkinson‘s disease or essential tremor, safety and effectiveness has not been established for patients with neurological disease other than idiopathic Parkinson‘s disease or essential tremor, previous surgical ablation procedures, dementia, coagulopathies, or moderate to severe depression, patients who are pregnant or patients under 18 years. For essential tremor, safety and effectiveness has not been established for bilateral stimulation or for patients over 80 years of age. For dystonia, safety of this device for use in the treatment of dystonia with or without other accompanying conditions (e.g., previous surgical ablation procedures, dementia, coagulopathies, or moderate to severe depression, or for patients who are pregnant) has not been established. The age of the implant is suggested to be that at which brain growth is approximately 90% complete or above. For epilepsy, the safety and effectiveness of this therapy has not been established for patients without partial-onset seizures, patients who are pregnant or nursing, patients under the age of 18 years, patients with coagulopathies, and patients older than 65 years.* Humanitarian device: Authorized by federal law as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis), in patients seven years of age or above. The effectiveness of the devices for treating these conditions has not been demonstrated.USA Rx only Rev 09/22

Features

Patient comfort
The smallest, thinnest, DBS device available,^‡ the Percept™ RC neurostimulator is designed for comfort.

Rapid recharging
Patients can charge from 10% to 90% in less than an hour, under normal conditions.^§

With more than 99% capacity at 15 years with weekly recharge, it is designed to offer a more consistent recharge experience over time.

Designed to adapt
BrainSense™ technology and advanced programming capabilities allow you to personalize therapy to your patients’ evolving needs over time.

Designed to automatically adapt for Parkinson's disease
The Percept™ RC device is part of the only sensing-enabled DBS system, with the world's first closed-loop feature for Parkinson's disease.

BrainSense™ Electrode Identifier
The electrode identifier provides a personalized, real-time snapshot of a patient's brain signals, which can help provide insights into the sensing "sweet spot"for programming.
BrainSense™ Adaptive DBS (aDBS)
The device automatically adjusts therapeutic stimulation through the day and night, giving patients with Parkison’s disease improved motor symptom (rigidity, bradykinesia, tremor) control for more of their day compared to cDBS.

The first of
its kind

Percept™ RC is the first complete rechargeable DBS system with sensing, directionality, and advanced programming capabilities.

Device features

Form factor: the smallest, thinnest implantable neurological stimulator (INS) commercially available for DBS^‡
15-year service life: no imposed shut-off date. 15-year supplemental warranty coverage^◊
Rapid recharge: Charge under normal conditions from 10% to 90% full in less than 60 minutes for implant depths of up to 2.0 cm.
3T and 1.5T full-body MRI: Only Medtronic allows patients to have stimulation on in bipolar mode during an MRI under certain conditions.^¶,1–3
Designed for upgradability: Engineered to allow for future software updates designed for the Percept™ platform without a neurostimulator device exchange.

Learn more about BrainSense™ technology

This is an image showing the Percept™ RC neurostimulator from the front and side view.

Ordering information

Neurostimulation system

Item number	Description
B35300	Percept™ RC neurostimulator — rechargeable neurostimulator with exclusive BrainSense™ technology

Compatible components and accessories leads

Item number	Description	Length (cm)	Electrode spacing (mm)
B3300542	SenSight™ directional lead kit, no marker	42	0.5
B3301542	SenSight™ directional lead kit, no marker	42	1.5
B3300533	SenSight™ directional lead kit, no marker	33	0.5
B3301533	SenSight™ directional lead kit, no marker	33	1.5
B3300542M	SenSight™ directional lead kit, with marker	42	0.5
B3301542M	SenSight™ directional lead kit, with marker	42	1.5
B3300533M	SenSight™ directional lead kit, with marker	33	0.5
B3301533M	SenSight™ directional lead kit, with marker	33	1.5

Extensions

Item number	Description	Length (cm)
B3400040	SenSight™ extension kit	40
B3400060	SenSight™ extension kit	60
B3400095	SenSight™ extension kit	95
B3400040M	SenSight™ extension kit with marker	40
B3400060M	SenSight™ extension kit with marker	60
B3400095M	SenSight™ extension kit with marker	95
37086	Stretch-coil DBS extension
7482	DBS dual prong extension — used with a pocket adaptor
7483	DBS dual prong extension — used with a pocket adaptor

Connector plugs

Item number	Description
B31061	SenSight™ connector plug

Pocket adaptors

Item number	Description
64001	Pocket adaptor — 1 × 4, connects Percept™ RC device to 7482 and 7483 dual prong extensions
64002	Pocket adaptor — 2 × 4, connects Percept™ RC device to 7482 and 7483 dual prong extensions

Clinician programmer

Item number	Description
8880T2	Communicator
CT900F	Clinician programmer

Patient programmer

Item number	Description
TH91DBS	Patient programmer includes:
	Item number	Description
	HH90	Patient handset
	TM91	Patient communicator

Wireless recharger kit

Item number	Description
RS6230	Wireless recharger kit includes:
	Item number	Description
	WR9230	Wireless recharger
	CD9000	Charging dock
	—	USB charging cable and AC power adapter
	—	Carrying case

Accessories

Item number	Description
B31000	SenSight™ burr hole device
B31030	SenSight™ extension tunneler kit
B31040	SenSight™ lead test cable kit
B32000	SenSight™ burr hole device kit
FP6000L	Optional patient pectoral drape — size: large, for use with RS6200 or RS6230 recharge system
FP6000M	Optional patient pectoral drape — size: medium, for use with RS6200 or RS6230 recharge system
FP6000S	Optional patient pectoral drape — size: small, for use with RS6200 or RS6230 recharge system
FP9000L	Optional patient waist belt for abdominal implants — size: large, for use with RS6200 or RS6230 recharge system
FP9000M	Optional patient waist belt for abdominal implants — size: medium, for use with RS6200 or RS6230 recharge system
FP9000S	Optional patient waist belt for abdominal implants — size: small, for use with RS6200 or RS6230 recharge system
FP9000X	Optional patient waist belt for abdominal implants — size: extra-large, for use with RS6200 or RS6230 recharge system

Resources

Percept™ Family Brochure (open in new window)

Learn about the Percept™ family with exclusive BrainSense™ technology.

PRODUCT PDF 12 MB

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† The sensing feature of the Percept™ RC system is intended for use in patients receiving DBS where chronically recorded bioelectric data may provide useful, objective information regarding patient clinical status. The majority of patients with Parkinson’s disease have an identifiable signal. A signal may not be present or measurable in patients treated for essential tremor, dystonia, or epilepsy. Humanitarian device: The effectiveness of these devices for the treatment of dystonia has not been demonstrated.

‡ Percept™ RC as compared to Boston Scientific Vercise Genus™ R16 and P16 (MP92328632-05 REV B), accessedFebruary 11, 2025, and Abbott Liberta RC™ IPG (ARTEN600337130 A), accessed February 11, 2025 and Abbott Infinity™ 5/7 IPG (ARTEN600150429 B), accessed February 11, 2025.

§ For implant depths of up to 2 cm.

◊ Percept™ RC neurostimulators sold in the United States are eligible for a 15-year supplemental limited warranty. For additional information, email  rs.rtgwarranty@medtronic.com. See additional warranty information.

¶ Medtronic DBS systems are MR Conditional. Refer to product labeling for full list of conditions. manuals.medtronic.com/manuals/mri/region.

1. MRI guidelines for Medtronic deep brain stimulation systems 37601 37602 37603 37612 B35200 B35300 — M929535A_a_092. manuals.medtronic.com/manuals/mri/region.

2. ImageReady™ MRI Guidelines for Boston Scientific Deep Brain Stimulation Systems — 92438760-07. bostonscientific.com/imageready/en-US/dbs-system.html. Accessed 6/12/24.

3. MRI Procedure Information for Abbott Medical™* MR Conditional Deep Brain Stimulation Systems — ARTEN600308948 A. neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Accessed 6/12/24.

Percept™ RC neurostimulator with BrainSense™ technology