FDA-approved deep brain stimulation family with sensing-enabled Percept neurostimulators and 8-contact SenSight directional leads. Values are scoped to the FDA record, Medtronic labeling and an independent technical report.
Independent, source-linked catalog sheet. Not a manufacturer-issued datasheet, regulatory decision or instructions for clinical use. Human evidence does not establish approval. Source-specific restrictions, conflicts and missing specifications are retained below.
Medtronic Percept and SenSight DBS
Percept PC (approved June 2020) and Percept RC (approved January 2024) are the current Medtronic DBS neurostimulators under PMA P960009. They pair with SenSight directional leads and can record local field potentials through BrainSense. This sheet separates the FDA record, Medtronic labeling and an independent technical paper.
Identity
Field
Value and source scope
Device
Medtronic Percept PC and Percept RC neurostimulators with BrainSense sensing and SenSight directional leads [1][2][3]
Manufacturer
Medtronic, Inc., Medtronic Neuromodulation [1]
Interface class
Implanted pulse generator with directional deep brain leads that can sense local field potentials [2][3]
Origin
Commercial FDA-approved device within PMA P960009 (Activa and Percept family) [1]
First demonstrated
Percept PC FDA approval June 24, 2020 (P960009/S361) [1][4]
First human implant
Unreported
Species studied
Unreported
Regulatory status
PMA P960009. Percept PC approved June 24, 2020 (S361); Percept RC B35300 approved January 8, 2024 (S438); SenSight lead kits May 25, 2021 (S391) [1]. Not an FDA clearance of any individual research result
Function
Stimulation and, in the Percept PC, wireless recording of local field potentials from the implanted site [2][5]
Target tissue
STN or GPi (Parkinson’s disease), VIM thalamus (tremor), ANT thalamus (epilepsy), GPi (dystonia, HDE history) [1][3]
Geometry and architecture
Field
Value and source scope
Interface type
SenSight directional lead with 1-3-3-1 electrode configuration, insulated orientation markers and single set-screw connection on a non-active contact [2]
Array layout
1-3-3-1 configuration [2]
Electrode count
8 contacts per SenSight lead (1-3-3-1) [2]
Pitch
1.5 mm and 0.5 mm electrode spacing options [2]
Electrode lengths
Unreported
Shank width and thickness
Unreported
Tip and exposed site geometry
Unreported
Contact coating
Unreported
Insulation
Unreported
Insertion method
Stereotactic lead with burr hole device and depth stop; SureTune 4 software automates orientation [1][2]
Anchoring and fixation
Burr hole device anchors the lead to the skull [1]
Electrode and channel physics
Field
Value and source scope
Exposed site area
Unreported
Electrode material
Unreported
Impedance (with measurement frequency)
Unreported
Noise floor or SNR
Unreported
Recording modality
Bipolar local field potential sensing in BrainSense modes (Setup, Streaming, Survey, Indefinite Streaming, Timeline) [5]
Sampling rate
Time-domain LFP at 250 Hz in the exported JSON files [5]
Stimulation capability
Directional stimulation with programmable amplitude, rate, pulse width, cycling and electrode configuration [1][2]
Charge injection limit
Unreported
Reference and ground
Unreported
Tissue interface and bioresponse
Field
Value and source scope
Target tissue
Deep brain targets listed under Identity [1][3]
Insertion trauma and BBB disruption
Unreported
Vascular disruption risk
Unreported
Micromotion sensitivity
Unreported
Gliosis and encapsulation
Unreported
Neuron loss near sites
Unreported
Foreign-body response mitigation
Unreported
Typical failure modes
Labeled device complications include lead or extension fracture, neurostimulator malfunction and high impedance [1]
System architecture
Field
Value and source scope
Onboard electronics
Implantable neurostimulator with sensing capability; clinician programmer, patient programmer and therapy access controller [1][3]
Data path
Wireless LFP recording; Streaming mode shows selected power and stimulation amplitude on the clinician tablet in real time; Passive mode collects band power chronically up to 60 days [5]
Telemetry bandwidth
Unreported
Sampling rate
250 Hz time-domain LFP [5]
Power
Percept PC described by Medtronic as recharge free with projected mean longevity greater than five years for a median energy user; Percept RC is rechargeable per the SSED’s component list [1][3]
Thermal management
Unreported
Packaging and hermeticity
Unreported
MRI compatibility
Medtronic states full-body MR Conditional access for 1.5T and 3T when conditions are met; non-conforming scans risk tissue lesions at the electrodes [2][3]
Surgical complexity
Stereotactic lead implant plus chest or abdominal neurostimulator pocket and extension [1]
Output connectors
Unreported
Performance envelope
Field
Value and source scope
Acute yield
Unreported
Chronic yield
Unreported
Stability over time
Unreported
Longevity
Projected mean greater than five years for median energy users (Percept PC, manufacturer figure) [3]
Revision and explant experience
In the SSED dystonia cohort (18 adults, 5 years), subcutaneous infection occurred in 16.7% (3/18) and electrode fracture in 5.6% (1/18); this is a GPi dystonia cohort, not Percept-specific [1]
Adverse events
Labeled risks include intracranial hemorrhage, infection, meningitis, brain abscess, cyst formation and neurological effects [1]
Notable demonstrations
First 20 patients at the authors’ centres (14 Parkinson’s, 5 dystonia, 1 chronic pain) had LFPs recorded wirelessly [5]
Clinical and preclinical evidence
Field
Value and source scope
Human subjects
20 patients in the Percept PC technical report (14 PD, 5 dystonia, 1 chronic pain) [5]. SSED supplement S482 reviews prior studies for dystonia
Preclinical cohort
Unreported
Follow-up duration
Unreported for the Percept hardware; SSED dystonia data run to 5 years [1]
Indications
Parkinson’s disease, essential and parkinsonian tremor, epilepsy (ANT), and dystonia per the November 22, 2025 SSED and Medtronic labeling [1][3]
Trials and registries
SSED cites investigator study 6 (Kupsch 2006, Volkmann 2012) for GPi dystonia [1]
Primary outcomes
Unreported for Percept sensing as a therapy outcome; the Percept PC report found it reliably recorded LFP from the implanted site [5]
Key limitations
The SSED read here supports a dystonia indication, so its safety tables are not specific to Percept sensing; the technical report names artefacts, contact selection, data loss and synchronization as pitfalls [1][5]
Engineering tradeoffs
Field
Value and source scope
Strengths
Sensing and directional stimulation in one family, with 1.5T and 3T MR Conditional eligibility [2][3]
Limitations
LFP artefacts, data loss and timing synchronization limit use of the recordings [5]
Scaling constraints
8 contacts per lead; sensing limited to bipolar pairs at 250 Hz in the exported data [2][5]
Version boundary
The newest approval in the SSED component list is Percept RC (S438, January 8, 2024). Specifications that Medtronic and the technical report give for the Percept PC are labeled as such. The November 22, 2025 SSED read here concerns the dystonia indication and does not report Percept-specific channel counts.