Implantable Pulse Generator
3. Pass the hex wrench through the hole in the septum located on the front or back of the IPG header
and tighten each set screw until the hex wrench "clicks," indicating lock.
CAUTION: Ensure that the lead is fully inserted before tightening the set screw to prevent lead
damage
Note: If a port plug is used, it is still necessary to tighten the set screw on the port plug as described
above.
Note: The hex wrench is torque-limited and cannot be over-tightened.
4. Place the IPG in the subcutaneous pocket with logo marking facing up towards the skin.
5. Coil excess lead, extension, splitter, or connector under the IPG.
6. If desired, secure the IPG in the pocket by suturing through the holes in the IPG header.
CAUTION: Do not suture through leads or splitter.
CAUTION: Tightening sutures directly on the lead can damage the lead. In addition, during an MRI
scan, the patient could be at risk of tissue heating, resulting in tissue damage or serious patient injury.
7. Close and dress the wound(s).
IPG Explant or Replacement
1. Turn off the IPG.
2. Surgically open the IPG pocket and withdraw the device. Please try to preserve the integrity of all
components so that complete device assessment can be performed.
3. Loosen the connector set screws to release and remove the leads, extensions, or splitters.
4. For replacement, connect the new IPG following the instructions for "Connecting the Lead, Extension,
Splitter, or Connector to the IPG" on page 9. Or, to terminate therapy, surgically remove the
implanted lead system.
5. Notify Boston Scientific to document the reason for explant or replacement and to arrange for return of
IPG and components.
Implantable Pulse Generator
91053242-08 Rev A
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Production
Boston Scientific Confidential. Unauthorized use is prohibited.
Montage MRI IPG Entrada 2.0 19L
92070454 A.1
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