Instructions For Use; Preparing For Surgery; Creating A Pocket For The Neurostimulator - Medtronic Percept PC B35200 Implantationsanleitung

Instructions for use

Implanting clinicians should be experienced in stereotactic and functional neurosurgery, and
deep brain stimulation procedures, as well as thoroughly familiar with all product labeling.

Preparing for surgery

Before surgery, note the following actions.
Warning: When using sharp instruments near the neurostimulator, be extremely
careful to avoid nicking or damaging the case, the insulation, or the connector block.
Damaging the neurostimulator, lead, or extension may cause inadequate stimulation.
This may require a surgical revision or replacement.
Caution: Before opening the sterile package, verify that the neurostimulator is ready
to be implanted. Use the clinician programmer to check communication with the
neurostimulator and read the neurostimulator battery service life. If communication is
not available, replacing the neurostimulator may prolong the surgery. If inadequate
neurostimulator battery life is not detected at implant, the neurostimulator may require
an early replacement surgery.
Caution: Gather the correct Medtronic tools for use during the implant procedure,
according to the instructions. Using the wrong tool or using the right tool incorrectly
can damage the neurostimulator or cause it to malfunction, which may require a
surgical revision or replacement. Replacing a neurostimulator or tools intraoperatively
may prolong the surgery.

Creating a pocket for the neurostimulator

Warning: Implant the device as far away as possible from another active implanted
device (for example, pacemaker, defibrillator) to minimize possible interaction between
the devices. For information on interactions between multiple devices, consult the
manufacturer's labeling for risks associated with the other devices.
Caution: Select a neurostimulator implant location that meets the following criteria:
▪
Away from bony structures to minimize discomfort at the neurostimulator site
▪
Away from areas of restriction or pressure to minimize the potential for skin
erosion and patient discomfort
▪
Accessible to the patient for proper operation of a patient control device
Any of these hazards may require a surgical revision or replacement.
Caution: Create a pocket that is no deeper than 4 cm and allows for the
neurostimulator to be placed parallel to the skin. If the neurostimulator is too deep or is
not parallel to the skin, telemetry may be unsuccessful.
1. Make an incision slightly larger than the width of the neurostimulator.
2. Create a subcutaneous pocket for the neurostimulator.
3. Verify the pocket size.
10 English B35200 2020-01-01