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4.
Gently tunnel the lead subcutaneously from the vein insertion site to the
implant pocket.
CAUTION:
Tunnel the lead from the chest area to the pulse generator
implant site. Do not tunnel the lead from the pulse generator implant site to the
chest area because this can damage the electrodes or lead body or both by
permanently stretching the lead.
CAUTION:
When tunneling the lead, take precautions not to place excessive
tension on the lead. This can cause either structural weakness and/or
conductor discontinuity.
CAUTION:
After tunneling, re-evaluate the lead to verify that no significant
change in signals or damage to the lead has occurred during the tunneling
procedure. Reattach the Connector Tool and repeat the steps in Evaluating
Lead Performance.
NOTE:
If the tunneling procedure must be delayed, cap the lead terminal and
form a temporary pocket for the coiled lead. Capping the terminal protects it
and prevents body fluids from entering the lumen of the lead.
5.
Reattach the lead terminals to the pulse generator and evaluate lead
signals with the pulse generator as previously described.
•
If the measurements are unacceptable, check the electrical
connections. A discontinuous or abnormal signal may indicate
dislodgment, a loose connection, or lead damage.
•
If necessary, reposition the lead electrodes until acceptable values are
obtained. To reposition the lead, carefully withdraw the tunneled
portion back to the venous entry site. Release the permanent ligatures
and reposition the lead using procedures previously discussed.
POSTIMPLANT
Postimplant Evaluation
Perform follow-up evaluation as recommended in the applicable pulse
generator physician's manual.
CAUTION:
For some patients, lead performance at implant may not predict
performance in the chronic state. Therefore, it is strongly recommended that
post-implant follow-up EP testing be performed should any change occur in
lead performance. This testing should include at least one arrhythmia
induction/conversion test of ventricular fibrillation.
WARNING:
Ensure that an external defibrillator and medical personnel
skilled in CPR are present during post-implant device testing should the patient
require external rescue.
NOTE:
Chronic repositioning of the lead may be difficult because of body
fluid or fibrotic tissue intrusion.
