User's Manual

SpinalModulation,Inc. PhysicianImplantManual

22
anglethaninanantegradeapproachandthereisagreaterchanceofduralpuncturethat
willleadtoacerebrospinalfluidleak.

4. Confirmentry intotheepiduralspaceusingstandardmethods, suchasalossofresistance
technique.

5. Once loss of resistance is achieved, the clinician may verify complete insertion into the
epidural space using fluoroscopic guidance and/or inserting the guidewire through the
needle.Ifresistanceisdiscoveredduringguidewireinsertion,eitherpulltheneedleoutand
repeat Steps 1‐4 using a more acute angle or advance the needle further and reconfirm
placementusingtheguidewire.
WARNING:Use fluoroscopy and extreme care when inserting, advancing, or
manipulatingthe guidewire orlead intheepiduralspacetominimizethe  riskofadural
tear.
WARNING:Duralpuncturecanoccurifneedleorguidewireisadvancedaggressivelyonce
lossofresistanceisachieved.Advancetheneedleand/orguidewireslowly.
6. Removetheguidewire(ifused)afterconfirmationofaccesstotheepiduralspace.
NOTE:TheComplexCurvedStylethasbeenpre‐insertedintothelead
andtheleadhasbeen
loadedintoa22cmSmallCurveSheathtofacilitatedeliverybytheclinician.
7. Beforeinsertionintotheneedle,pushtheleadoutsidethesheathandverifythatthestylet
ispushedfullydistalwithinthelead.
NOTE:Failure to ensure the stylet is completely inserted may make delivery of the lead
moredifficult.
8. Beforeinsertionintotheneedle,pullbackontheleadsothattheball‐tipendoftheleadis
flush against the Delivery Sheath and tighten down the lead stabilizer until the lead does
notslidewithinthesheath.