User's Manual

SpinalModulation,Inc. PhysicianImplantManual

31
7. Removetheneedlefollowingthesameprocedure.
8. Itisrecommendedthatthe desiredparesthesiabere‐testedaftertheremovalofthe
deliverysystemcomponentsbutbeforethecompleteremovalofthestylet.Withthe
externalTNSamplitudesetto0µA,reconnecttheConnectorCableasdescribedbefore.
WARNING:Donotuseexcessiveforceifthe  lea d  needs toberemoved.Excessiveforce
maycauseleadfracture.
9. Recordtheleadposition withbothanA/Pandlateralfluoroscopicviewforcomparisonof
thepositionattimeofclosuretoensurethattheleadhasnotmoved.Removethestylet
byholdingforw ardpressureontheleadwhileretractingthestylet.
WARNING:Use extreme care when removing the  lead sty let, the delivery sheath, and
the needle, to ensure that the distal tip of the lead remains in the desired location.
Removing each item in slow mov ements,  while holding the remaining co mponents in
place,willassistthisprocess.
LeadAnchoring
Afterplacingalead initsfinalposition,itshouldbesecuredusingasofttissueanchorandthen
connectedtoexternalizedextensions.
WARNING:Donotsuturedirectlyontothelead, asthereisariskofdamagingthelead. 
Failure to secure the lead to the skin, or other tissue, may result in lead migration and
uncomfortablemusclestimulation.
PRECAUTION: Use extreme care when using sharp instruments or electrocautery around
theleadtoavoiddamagingthelead.
1. Soaktheanchorinsterilewater(notsaline)tolubricateit.
2. Place the anchor on the lead and slide  it down as close as possible to where the lead
emergesfromthevertebralcolumn.Becarefulnottomove thelead.
NOTE:Ifimplantingmultipleleads,tagtheleadswithsuture(ligature)sothattheirposition
canbeidentifiedlater.
PRECAUTION: Observe these cautions when attaching the soft tissue  anchor because
damagetotheanchororleadcanoccurandresultinfailureofthesystem:
• Donotusepolypropyleneor monofilamentsuture
• Donotplacesuturesdirectly on thelead.
• Avoidsharpbendsorkinkingon
thelead.