CVRx BAROSTIMIPG1 Manual De Usuario
BAROSTIM NEO LEGACY REFERENCE GUIDE
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Recommendations
An IPG replacement procedure should be performed on or before the Recommended Replacement Time.
The surgical approach and techniques for the replacement of the IPG will vary with the preference of the
surgeon performing the procedure. Although the approach and the techniques may vary, essential requirements
for proper and safe replacement of the IPG are included in this section.
surgeon performing the procedure. Although the approach and the techniques may vary, essential requirements
for proper and safe replacement of the IPG are included in this section.
Local anesthetics are typically used during this replacement procedure.
Antibiotic Coverage
It is recommended that an antibiotic providing gram-positive coverage be administered within 30 minutes of
the skin incision and continued postoperatively for 24 hours following the procedure.
the skin incision and continued postoperatively for 24 hours following the procedure.
Explantation of Depleted IPG
NOTE: During the explantation procedure, take care to avoid damage to the implanted leads. Electrocautery at
a low but effective power can be used to minimize the potential of damaging the leads during dissection. Do
not use scalpels on or near the CSL as damage could occur leading to failure of the lead.
a low but effective power can be used to minimize the potential of damaging the leads during dissection. Do
not use scalpels on or near the CSL as damage could occur leading to failure of the lead.
1. Disabled therapy:
i. If the device to be explanted is a Neo Legacy IPG, initiate a telemetry session with the IPG and press
the Stop ,button. Save Report (if desired) and End Session.
ii. If the device to be explanted is a Rheos IPG, initiate a telemetry session with the IPG using the Rheos
9000 Programmer System. Record the current device settings, then turn the Master Off. Exit the
Rheos software application.
Rheos software application.
2. Open the incision inferior to the clavicle over the implanted IPG.
3. Using electrocautery or blunt dissection, dissect down to the IPG. Portions of the lead(s) may need to be
dissected in order to remove the IPG.
4. Cut the fixation sutures. Prior to removing the IPG, it is recommended to disconnect the lead(s) from the
connector ports (refer to steps 5 and 6). Remove the IPG from the pocket.
5. Using the torque wrench, turn the setscrews counterclockwise to loosen the setscrews for each CSL
connector.
6. Remove the CSL(s) from the IPG connector ports, ensuring that the left and right leads (if applicable) can
be properly identified during reconnection.
7. Remove the IPG from the sterile field.
8. Return the explanted IPG to CVRx for examination and proper disposal.
NOTE: Prior to returning the IPG, obtain a CVRx Returned Goods Authorization kit and follow the procedure
contained within it.
contained within it.