Pre-Op Instructions; Ipg Implantation - Boston Scientific Precision Montage SC-1200 Mode D'emploi

Implantable Pulse Generator

Pre-Op Instructions

1. Ensure that the IPG is fully charged prior to the permanent implant procedure. The approximate
location of the IPG is marked on the IPG kit. Turn on the Charger and place it over the IPG to begin
charging. Refer to "Charging Steps" on page 11 for additional instructions.
2. Check that the sterile package is intact. (See "Sterilization" in the Information for Prescribers manual
for the Precision Montage MRI SCS System.)
3. If intra-operative stimulation testing is desired, ensure that a Trial Stimulator is available for use. Refer
to the Clinician Trial Manual for your SCS System for additional instructions.

IPG Implantation

1. Ensure that the area surrounding the lead entry site is incised to a dimension that will accommodate
the tunneling tool.
2. Check that the lead is securely anchored.
CAUTION: Do not use polypropylene sutures as they may damage the suture sleeve. Do not suture
directly onto the lead, or use a hemostat on the lead body. This may damage the lead insulation. In
addition, during an MRI scan, the patient could be at risk of tissue heating, resulting in tissue damage
or serious patient injury.
3. Select and mark the intended IPG site, using the IPG template, and create an incision for the IPG
pocket.
4. Create a subcutaneous pocket no larger than the IPG outline at a depth of up to 2.0 cm from the
surface. Implant charging could become ineffective at depths shallower than 0.5 cm or greater than
2.0 cm.
Note: For full-body MRI scan eligibility, confirm that the subcutaneous pocket for the IPG has been
created in the upper buttock or lower flank. (See the caution in "SCS Implant Conditions for Full
Body MRI Eligibility" in this manual).
5. Tunnel the lead(s) to the IPG site.
Note: Using the IPG template will help guide the correct pocket sizing. It is important to keep the pocket
small to reduce the chances of patient manipulation and IPG flipping. Select an IPG site several
inches away from the previously externalized trial lead site to reduce risk of infection.
Implantable Pulse Generator
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Montage MRI IPG Entrada 2.0 19L
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