User's Manual

SpinalModulation,Inc. PhysicianImplantManual

7
IndicationsforUse
The Axium™ Neurostimulator System is indicated as an aid in the management of chronic
intractablepainofthetrunkand/orlimbs.
Contraindications
PatientscontraindicatedfortheAxium™NeurostimulatorSystemarethosewho:
• Have an active implantable medical device including but not limited to cardiac
pacemakersandcardiacdefibrillators
• Areunabletooperatethesystem
• Arepoorsurgicalrisks
• Arepregnant
• Areundertheageof18
SystemDescription
TheAxium™NeurostimulatorSystemconsistsofthefollowingcomponents:
Component
Name
Model
Numbers
PackageContent InstructionsforUse
Trial
Neurostimulator

MN10100
MN20100
• TrialNeurostimulator
TrialNeurostimulator
Manual
Implantable
Neurostimulator
MN10200
MN20200
• ImplantableNeurostimulator
• LeadPortPlugs(3)
• TorqueWrench
• SterileMagnetSleeve
• MedicalAlertCard
PhysicianImplant
Manual
TrialLeadKit
(lengthincm
specifiedby‐XX)

MN10350‐XX
MN20350‐XX

• TrialLead
• 22cmSmallCurveDeliverySheath
• 22cmBigCurveDeliverySheath
• Guidewire
• ComplexCurvedStylet
• 4.5”14GDeliveryNeedle
• SoftTissueAnchor(2)
PhysicianImplant
Manual