BASIC EVALUATION

CLINICAL SETUP
GUIDE
enhanced Verify™ Evaluation System
for Sacral Neuromodulation
 Position the Patient:
Place the patient comfortably on the table
in a prone position. Place a pillow under the
lower abdomen, and ensure the patient’s
feet are exposed and dangling freely.
If fluoroscopy is used, ensure the C-arm can
slide under the bed for A/P and lateral views.

Prep and Drape:

Prep for sterile surgery by swabbing the
lower back, pre-sacral region, and buttocks
with an antiseptic.

Drape the patient to allow for observation

of the pelvic floor and great toe motor
responses.
Ensure a clear view over the buttock and
perineal area.

Connect Components:
After the proximal end of the Test
Stimulation Cable is handed off the
prepped field, attach the ground pad to
the patient’s heel.

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 Attach the black pin end to the ground pad.

Plug the adapter end of the Test Stimulation

Cable into the External Neurostimulator
(ENS).

Confirm Programmer Settings:

Once the Test Stimulation cable is connected
pair the programmer with the ENS. After
you open the clinician app, Select “External”
Device Type. The programmer will search
for the ENS and allows the clinician to pair by
serial number. The “Link” icon appears with a
previously paired ENS. Once connected, the
home screen appears. Select the “Place lead”
workflow when you are ready to begin testing.

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 If connections are not secure, the cable not
attached notification screen will appear.

To confirm desired needle placement,

connect the Test Stimulation Cable to the
non-insulated portion of the foramen needle.
Increase the stimulation as directed by the
physician. Observe for motor and sensory
responses.

Insert Test Stimulation Lead:

Insert the temporary Test Stimulation Lead
through the foramen needle until the lead
electrode exits the needle tip.

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 Confirm Ideal Lead Response:
Test for motor and sensory responses by
hooking the Test Stimulation Cable to the
connector pin on the end of the temporary
Test Stimulation Lead. Once desired
stimulation is confirmed, decrease the ENS
amplitude to zero. Stabilize the lead and
carefully remove the needle and lead stylet.

Disconnect the Test

Stimulation Cable:
Press “done” on the place lead screen
when you are finished. Disconnect the
test stimulation cable from the ENS. The
stimulation will automatically turn off. The
the ‘cable not attached’ notification will
appear.

Connect Leads to Patient Cable

(Dual Lead Placement):
Ensure the temporary Test Stimulation
Leads are secured with dressing. Insert the
exposed end of the left Test Stimulation
Lead into the white plug on the Patient
Cable. Insert the right Test Stimulation
Lead into the red plug on the Patient Cable.
To ensure patient comfort, place gauze
under the plug connections.

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 Connect Lead to Patient Cable
(Single Lead Placement):
When only one lead is placed, a Patient
Cable with ground pad will be used to
connect the temporary Test Stimulation
Lead to the ENS. Insert the exposed end
of the Test Stimulation Lead into the
appropriate Patient Cable plug. The unused
plug will remain unattached. Connect the
black plug of the Patient Cable into the
ground pad and attach to the patient. To
ensure patient comfort, place gauze under
the plug connection.

Allow for Strain Relief and Secure

Connection with Dressing:
Cover the connections with dressing and
secure the ENS to the patient. Allow for
Patient Cable strain relief.

Connect Patient Cable to the

ENS and Secure ENS in Belt:
Insert Patient Cable adapter end into
the ENS. Secure the ENS in the belt.

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 Configure Evaluation
After the procedure is complete, you will
need to use the Configure Evaluation
Workflow which can be accessed through the
Clinician app home screen. Click Configure
Evaluation. Under “preparation” reset the
app to delete previous patient information.
Under “patient” enter in the patient’s
information. The next screen, “status,” gives
the clinician ENS battery life and impedance
readings. Under “therapy” ensure that
either the right or left side is turned “ON.”
A clinician can click the right or left side to
turn stimulation “ON” then increase the
stimulation. The “summary” screen give a
clinician an overview of the active side and
an option to view the session report. Click
“done” when finished.

Post-Procedure Discussion
and Next Steps:
IInstruct the patient on post-operative
care, the importance of completing a diary,
how to use the programmer using the My
Therapy app and when to contact the clinic
for follow up. Ensure each patient recieves
the Enhanced Verify Patient Quick Start
Guide.

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Indications for Use:
Sacral Neuromodulation delivered by the InterStim™ system for Urinary Control is indicated for the treatment of urinary
retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms
of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative
treatments.

The following Warning applies only to Sacral Neuromodulation for Urinary Control:

Warning: This therapy is not intended for patients with mechanical

obstruction such as benign prostatic hypertrophy, cancer, or urethral stricture.

Sacral Neuromodulation delivered by the InterStim™ system for Bowel Control is indicated for the treatment of chronic
fecal incontinence in patients who have failed or are not candidates for more conservative treatments.

Contraindications for Urinary Control and for Bowel Control: Diathermy. Patients who have not demonstrated an
appropriate response to test stimulation or are unable to operate the neurostimulator.

Warnings/Precautions/Adverse Events:
For Urinary Control: Safety and effectiveness have not been established for bilateral stimulation; pregnancy, unborn
fetus, and delivery; pediatric use under the age of 16; or for patients with neurological disease origins.
For Bowel Control: Safety and effectiveness have not been established for bilateral stimulation; pregnancy, unborn fetus,
and delivery; pediatric use under the age of 18; or for patients with progressive, systemic neurological diseases.
For Urinary Control and for Bowel Control: The system may be affected by or adversely affect cardiac devices,
electrocautery, defibrillators, ultrasonic equipment, radiation therapy, MRI, theft detectors/ screening devices. Adverse
events include pain at the implant sites, new pain, lead migration, infection, technical or device problems, adverse
change in bowel or voiding function, and undesirable stimulation or sensations, including jolting or shock sensations.
Patients should be assessed preoperatively for the risk of increased bleeding. For full prescribing information, please call
Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com. Product technical manual
must be reviewed prior to use for detailed disclosure.

USA Rx Only. Rev 0517

UC201602184b EN © 2019 Medtronic, Inc. All Rights Reserved.

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Minneapolis, MN 55432
USA
Tel. 1-763-505-5000

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