User's Manual

SpinalModulation,Inc. PhysicianImplantManual
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20
B. Implanted Lead + Percutaneous Extension Trial – A  trial is done with an Implant Lead
sutured to the soft tissue just above the spinous process, using the soft tissue anchor to
protect the lead.An extension is tunneled away from the needle insertion site where it
exitstheskin.InasecondprocedureonlytheLeadExtensionisremovedandtheLeadora
new Lead Extension is tunneled to a pocket, the INS is implanted  in the pocket, and the
LeadorLeadExtensionisconnectedtotheINS.
PreparingthePatientandDevicesforUse
Leads are designed for placement in the epidural space.Each Lead is accompanied by
accessoriesdesignedtoaidtheclinicianinpositioningthetipoftheLeadnearthetargetDRG.
• ToperformaPercutaneousLeadtrial,usethetemporaryTrialLeadKit.
• ToperformanImplantLeadtrial,usetheImplantLeadKit.
CAUTION:ThetemporarilyplacedTrialLeadsareintendedforuseforupto30days.Useof
these devices must be performed in accordance with the instructions provided in this
manual.
Usingstandardsteriletechnique,performtheappropriateskinprepping,draping,andinjection
oflocalanesthetictoperformtheepiduralapproachesforpercutaneousleadplacement.
WARNING: The placement of the leads involves  some risk, as with any surgical
procedure.Conscious sedation can cause side effects such as systemic toxicity, or
cardiovascular or pulmonary problems.Use caution when sedating the  patient.The
patientmustbeawakeandconversantduringportionsoftheproceduretominimizethe
likelihoodofnervedamage.
PlacingtheLead
Leadplacementshouldalwaysbedoneunderfluoroscopicguidance.Theappropriatevertebral
levelforneedleentryshouldbeidentifiedandmarked.
WARNING:Aswithanyspinalepiduralprocedure,potentialrisksofseriousinjuryto the
patient, although extremely rare, include epidural hemorrhage, hematoma, infection,
spinalcordornervecompression,and/orparalysis.
1. Determinethelength oftheleadrequiredtoextendfromthetargetforaminalleveltothe
Neurostimulator implantation  site.
Using a 90 cm lead in the lumbar region may cause
difficultyincoilingtheexcesslead.A50cmleadusedintheupperthoracicregionmaynot
belongenoughtoreachtheNeurostimulatorandaleadextensionmaybeneededtobridge
theadditionallength.
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