FDA-approved rechargeable sacral neuromodulation system with a four-contact tined lead. Values come from the 2019 FDA summary for the fecal incontinence indication.
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.
Axonics sacral neuromodulation
The Axonics system is a rechargeable sacral neuromodulation stimulator. This sheet reads the FDA summary for PMA P190006 (fecal incontinence, approved September 6, 2019). Clinical results and the urinary indication were not read and stay Unreported.
Identity
Field
Value and source scope
Device
Axonics Sacral Neuromodulation System: IPG Model 1101, Tined Lead Models 1201 and 2201, Surgical Tool Kit 1801, PNE lead Model 1901, external trial stimulator, remote control, charger and clinician programmer [1]
Manufacturer
Axonics Modulation Technologies, Inc., Irvine, California [1]
Interface class
Rechargeable sacral neuromodulation stimulator with a four-contact tined lead [1]
Origin
Commercial FDA-approved device; this sheet reads PMA P190006 (fecal incontinence). The same family’s other PMA, P180046, was found but not read [1]
First demonstrated
Unreported
First human implant
Unreported
Species studied
Unreported
Regulatory status
PMA P190006 approved September 6, 2019 for chronic fecal incontinence, with no panel recommendation [1]
Function
Applies electrical stimulation to the sacral nerves for chronic fecal incontinence in patients who have failed or are not candidates for more conservative treatments [1]
Target tissue
Sacral nerve at the foramen [1]
Geometry and architecture
Field
Value and source scope
Interface type
Tined lead placed just posterior to the sacral foramen, tunneled to the upper buttock where the IPG sits [1]
Array layout
4 cylindrical electrodes in a line [1]
Electrode count
4 [1]
Pitch
3 mm electrode spacing [1]
Electrode lengths
Lead length 30 cm; electrode size 3 mm [1]
Shank width and thickness
Lead diameter 1.3 mm (5 French) [1]
Tip and exposed site geometry
Unreported
Contact coating
Unreported
Insulation
Unreported
Insertion method
Introducer sheath and dilator through the foramen; foramen needle can deliver up to 12.5 mA, 450 us and 130 Hz during testing [1]
Anchoring and fixation
Anchoring tines on the lead [1]
Electrode and channel physics
Field
Value and source scope
Exposed site area
Unreported
Electrode material
Unreported
Impedance (with measurement frequency)
Lead DC resistance acceptance limit under 135 ohm; this is lead resistance, not electrode-tissue impedance [1]
Noise floor or SNR
Unreported
Recording modality
Unreported
Sampling rate
Unreported
Stimulation capability
2.1 to 130 Hz from the IPG; trial with a temporary lead up to 7 days or a permanent lead up to 14 days, with at least a 50% drop in incontinent episodes needed to proceed [1]
Charge injection limit
Unreported
Reference and ground
Unreported
Tissue interface and bioresponse
Field
Value and source scope
Target tissue
Unreported
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
Unreported
System architecture
Field
Value and source scope
Onboard electronics
Unreported
Data path
Unreported
Telemetry bandwidth
Unreported
Sampling rate
Unreported
Power
Rechargeable battery, 50 mAh at 3.6 V nominal; device life 15 years at moderate energy [1]
Thermal management
Unreported
Packaging and hermeticity
Unreported
MRI compatibility
Unreported
Surgical complexity
Trial phase with a temporary or percutaneous lead, then a permanent lead and an IPG pocket in the upper buttock [1]
Output connectors
Unreported
Performance envelope
Field
Value and source scope
Acute yield
Unreported
Chronic yield
Unreported
Stability over time
Unreported
Longevity
Unreported
Revision and explant experience
Unreported
Adverse events
Unreported
Notable demonstrations
Unreported
Clinical and preclinical evidence
Field
Value and source scope
Human subjects
Unreported
Preclinical cohort
Unreported
Follow-up duration
Unreported
Indications
Chronic fecal incontinence in patients who failed or are not candidates for more conservative treatments (P190006) [1]
Trials and registries
Unreported
Primary outcomes
Unreported
Key limitations
Clinical study sizes and outcomes in the SSED were not read for this sheet, and the urinary indication PMA was not read [1]
Engineering tradeoffs
Field
Value and source scope
Strengths
Rechargeable with stated 15-year device life at moderate energy [1]
Limitations
Unreported
Scaling constraints
Unreported
Version boundary
The sheet describes IPG Model 1101 and the tined leads as listed in the 2019 summary. Later models and supplements were not reviewed.