InterStim® Therapy
InterStim® II Model 3058 Neurostimulator
InterStim
Implant manual
®
Model 3023 Neurostimulator
3058
3023
Rx only
2006 (3058)
1995 (3023)
Explanation of symbols on product or package labeling
STERILIZE
2
XXX °F
XX °C
-XX °F
-XX °C
Open here
Do not reuse
EO
STERILE
Sterilized using ethylene oxide
Use by
Serial number
Do not use if package is damaged
Conformité Européenne (European Conformity). This symbol means
that the device fully complies with AIMD Directive 90/385/EEC
(NB 0123).
Date of Manufacture
Consult instructions for use
Do not resterilize
Temperature limitation
Manufacturer
REP
EC
Authorized representative in the Europe2016an community
For USA audiences only
InterStim Therapy 2016-06-01 English 1
Medtronic, InterStim, and SoftStart/Stop are trademarks of Medtronic, Inc., registered in
the U.S. and other countries.
2 English 2016-06-01 InterStim Therapy
Table of contents
Introduction 5
Device description 5
Package contents 5
Patient registration and identification card 5
Device specifications 5
X-Ray identification 8
Instructions for use: Model 3058 9
Verifying neurostimulator operation 9
Creating a pocket for the Model 3058 Neurostimulator 9
Connecting the lead to the Model 3058 Neurostimulator 10
Implanting the Model 3058 Neurostimulator 13
Completing the implant procedure 14
Replacing the Model 3058 Neurostimulator 14
Device description 15
Package contents 15
Patient registration and identification card 15
Device specifications 15
X-Ray identification 18
Instructions for use: Model 3023 19
Verifying neurostimulator operation 19
Creating a pocket for the Model 3023 Neurostimulator 19
Connecting the extension to the Model 3023 Neurostimulator 20
• Refer to the appropriate Information for Prescribers (IFP) booklet for contraindications,
warnings, precautions, adverse events summary, individualization of treatment, patient
selection, use in specific populations, resterilization, and component disposal.
• Refer to the Indications Insert for indications and related information.
• Refer to the System Overview and Compatibility Insert for information regarding device
compatibility.
Note: Some product models described in this manual may not be available in all
geographies.
•
Refer to the Clinical Summary for information on the clinical study results for
InterStim Therapy and for a complete summary of adverse events.
Refer to the Limited Warranty and Special Notice Insert for warranty information.
•
• Refer to the System Eligibility, Battery Longevity, Specifications reference manual for
neurostimulator selection, battery longevity calculations, and specific neurostimulator
specifications.
InterStim Therapy 2016-06-01 English 3
Implanting the Model 3023 Neurostimulator 23
Completing the implant procedure 24
Replacing the Model 3023 Neurostimulator 24
Declaration of conformity 25
Control magnet 26
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InterStim II Model 3058 Neurostimulator
Introduction
This manual includes information about two devices used separately as part of a Medtronic
InterStim System. The Medtronic InterStim II Model 3058 Neurostimulator is used with a
lead and the Medtronic InterStim Model 3023 Neurostimulator is used with a lead and an
extension.
InterStim II Model 3058 Neurostimulator
Device description
The Medtronic InterStim II Model 3058 Neurostimulator is part of a neurostimulation
system for InterStim Therapy.
Package contents
ƒ Neurostimulator
ƒ Torque wrench
ƒ Product literature
Patient registration and identification card
The implant registration form registers the device and creates a record of the device in
Medtronic’s implant data system.
A patient identification card is package with this device. Advise the patient to carry the
identification card at all times.
The patient identification card packaged with the device is temporary; a permanent
card will be mailed to the patient when Medtronic receives the implant registration form.
Device specifications
The neurostimulator is a programmable device that accommodates a lead through which
a stimulation program is delivered.
Refer to Table 1 for shipping, operating, and power-on-reset values. Refer to Table 2 for
physical characteristics. Refer to Table 3 for materials of package components.
InterStim Therapy 2016-06-01 English 5
InterStim II Model 3058 Neurostimulator
Table 1. Shipping, operating, and power-on-reset (POR) values for the
Medtronic InterStim II Model 3058 Neurostimulator
a
.
Programmable Parameters Shipping Operating POR
Amplitude
Normal Resolution
Upper Limit
Lower Limit
Fine Resolution
Upper Limit
Lower Limit
Rate 14 Hz 49 values
0.0 V
0.0 V
0.0 V
---
---
---
100 mV steps
8.5 V maximum
0.0 V minimum
50 mV steps
6.35 V maximum
0.0 V minimum
0.0 V
0.0 V
0.0 V
---
---
---
31 Hz
(from 2.1 to 130 Hz)
Pulse width 210 μs Increments of 30 μs steps
450 μs maximum
60 μs minimum
210 μs
Operating Mode Continuous Continuous or Cycling Continuous
c
Cycle On/Cycle Off time
SoftStart/Stop
d
Output On/Off
Polarity
a
All values are approximate.
b
Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all
electrodes to OFF. POR can occur when there is a temporary fluctuation in battery
voltage (eg, due to electromagnetic interference during electrocautery or defibrillation) or
the battery is depleted. When POR occurs, the serial number is reset to a nominal value
and must be entered with the clinician programmer.
c
Cycle On and Cycle Off time must be greater than or equal to the SoftStart/Stop time.
d
SoftStart/Stop must be less than or equal to the Cycle On and Cycle Off time.
e
If case electrode is positive, electrodes 0-3 may be programmed to Off or – only.
Electrode
Number
0
1
2
3
Case
0.1 sec 0.1 sec to 24 hr 0.1 sec
Off 1, 2, 4, 8, 15, 30 sec, or
Off
Off On or Off Off
–
Off
Off
+
e
Off
Off, + or –
Off, + or –
Off, + or –
Off, + or –
Off or +
Off
–
Off
Off
+
Off
b
6 English 2016-06-01 InterStim Therapy
InterStim II Model 3058 Neurostimulator
Table 2. Physical characteristics of the InterStim II Model 3058
Neurostimulator.
a
Description Value
Height 44 mm (1.7 in)
Length 51 mm (2 in)
Thickness 7.7 mm (0.3 in)
Weight 22 g (0.77 oz)
3
Volume 14 cm
(0.85 in3)
External shield Titanium
Power source
b
1.3 Amp Hours, 3.2 V
Lithium silver vanadium oxide hybrid
Storage temperature -18 °C to 52 °C (0 °F to 125 °F)
Serial Number
Radiopaque Identification
(ID)
a
All measurements are approximate.
b
The power source is hermetically sealed within the case.
c
The serial number is the radiopaque ID followed by a number. The clinician programmer
c
NJY
displays the entire number beginning with the radiopaque ID.
InterStim Therapy 2016-06-01 English 7
InterStim II Model 3058 Neurostimulator
X-Ray identification
Radiopaque identification permits the determination of manufacturer and neurostimulator
model number (Figure 1). With standard x-ray procedures, the code appears as black
characters on white background. The Medtronic symbol identifies Medtronic as the
manufacturer. For the Medtronic InterStim II Model 3058 Neurostimulator, the designated
characters are NJY.
Figure 1. The InterStim II Model 3058 Neurostimulator
radiopaque code block.
Table 3. Material of components in the Model 3058 package.
Structure Material Material Contacts Human Tissue
a
Case
Connector Urethane Yes
Grommets, seals, strain
relief
Setscrew and
electrical contacts
Adhesive Silicone
Torque wrench
Handle
Shaft
a
The electronics and power source are hermetically sealed within the case.
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Titanium Yes
Silicone rubber Yes
Titanium Yes
adhesive
Polyetherimide
Stainless steel
Yes
Yes
Yes
InterStim II Model 3058 Neurostimulator
Instructions for use: Model 3058
Cautions:
ƒ When using sharp instruments near the neurostimulator, be careful to avoid
nicking or damaging the case or the connector block. Damaging the
neurostimulator may require surgical replacement.
ƒ Do not use saline or other ionic fluids at connections, which could result in a
short circuit.
Verifying neurostimulator operation
Before opening the sterile neurostimulator package, use the clinician programmer to
interrogate the neurostimulator and verify neurostimulator battery status and current
settings.
Caution: Do not implant a neurostimulator if it was dropped onto a hard surface
from a height of 30 cm (12 in) or more, because the neurostimulator may be
damaged and fail to operate properly.
Creating a pocket for the Model 3058 Neurostimulator
1. Create a subcutaneous pocket for the neurostimulator by blunt dissection to the
anterior surface of the muscle. The neurostimulator is placed in the upper buttock
area.
Notes:
ƒ The Model 3058 Neurostimulator should be placed no deeper than 2.5 cm (1 in)
below the skin and should be parallel to the skin. If the neurostimulator is too deep
or is not parallel to the skin, telemetry may be unsuccessful.
ƒ If the patient has any other neurostimulator, the neurostimulators must be
separated by a minimum of 20 cm (8 in).
Cautions:
ƒ The neurostimulator is provided sterile. Do not soak the neurostimulator in
antibiotic solution. Soaking in antibiotic solution can affect lead connections.
ƒ To avoid infection, it is recommended that the neurostimulator implant site
be irrigated with antibiotic solution, and that IV antibiotics be administered
perioperatively. Do not allow the neurostimulator to come into contact with
any non-sterile surface. Do not place on skin. If an infection occurs, it may
require surgical removal of the implanted system.
2. Place the neurostimulator in the pocket to assure proper fit and then remove it. Keep
the neurostimulator sterile and clean.
3. Tunnel from the lead incision site to the neurostimulator pocket. Refer to the product
literature packaged with the lead for detailed tunneling and lead implant instructions.
InterStim Therapy 2016-06-01 English 9
InterStim II Model 3058 Neurostimulator
4. Connect the lead to the Model 3058 Neurostimulator according to the steps in
“Connecting the lead to the Model 3058 Neurostimulator” in this manual.
Connecting the lead to the Model 3058 Neurostimulator
Caution: Before connecting components, wipe off any body fluids and dry all
connections. Fluids in the connection may result in stimulation at the connection site,
intermittent stimulation, or loss of stimulation.
1. Wipe the proximal lead electrode connections with sterile gauze. If necessary, use
sterile (United States Pharmacopeia [USP]) water or a nonionic antibiotic solution,
then wipe dry.
2. Make sure the connector block receptacle is dry and clean.
3. Confirm that the lead has four electrodes matching the encapsulated diagram on the
neurostimulator (Figure 2).
4. Insert the lead into the neurostimulator connector block until fully seated (Figure 2).
Caution: Do not pull the lead body taut when implanted. The lead is available in
different lengths. Select a lead length that allows connection without tension.
Note: To retract the setscrew, insert the torque wrench into the self-sealing grommet
and rotate the setscrew counterclockwise; however, do not remove the setscrew from
the connector block (Figure 3).
Caution: Do not insert the lead into the connector block if the setscrew is not
sufficiently retracted. If the setscrew is not retracted, the lead may damage the
setscrew and the lead then will not seat fully into the connector block.
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InterStim II Model 3058 Neurostimulator
Encapsulated
Diagram
Figure 2. Insert lead fully into Model 3058 Neurostimulator connector block.
Figure 3. To back out the setscrew from the Model 3058 Neurostimulator, use the torque
Note: The torque wrench must be oriented to the same angle as the setscrew
(Figure 3).
InterStim Therapy 2016-06-01 English 11
wrench and turn setscrew counterclockwise.
InterStim II Model 3058 Neurostimulator
5. Fully insert the torque wrench into the self-sealing grommet of the connector block and
tighten the setscrew by turning clockwise until the torque wrench clicks (Figure 4).
Cautions:
ƒ Be sure the torque wrench is fully inserted into the self-sealing grommet. If
the torque wrench is not fully inserted, the setscrew may be damaged,
resulting in intermittent or loss of stimulation.
ƒ Before tightening the setscrew, ensure that the lead is inserted into the
connector block to prevent damaging the connector block.
ƒ Verify that the self-sealing grommet is closed after the torque wrench is
withdrawn. If fluid leaks through a grommet seal that is not fully closed, the
patient may experience shocking, burning, or irritation at the neurostimulator
implant location, or intermittent stimulation or loss of stimulation may occur.
ƒ Discard the torque wrench after making the connection. The torque wrench
is single-use-only. Its operation cannot be assured if it is used for multiple
surgeries.
Figure 4. Tighten the setscrew in the self-sealing grommet by turning clockwise until the
Note: The torque wrench must be oriented to the same angle as the setscrew
(Figure 4).
12 English 2016-06-01 InterStim Therapy
torque wrench clicks.
InterStim II Model 3058 Neurostimulator
Implanting the Model 3058 Neurostimulator
1. Place the neurostimulator into the subcutaneous pocket with the etched identification
side placed outward, away from muscle tissue, and ensure that the lead is not bent
sharply.
Note: The Model 3058 Neurostimulator should be placed no deeper than 2.5 cm (1 in)
below the skin and should be parallel to the skin. If the neurostimulator is too deep or
is not parallel to the skin, telemetry may be unsuccessful.
Caution: Do not coil excess length in front of the etched identification side of the
neurostimulator. Wrap excess length around the perimeter of the neurostimulator
(Figure 5) to avoid increasing subcutaneous pocket depth, help minimize
potential damage during neurostimulator replacement surgery, help minimize
potential kinking, and minimize interference with telemetry during programming.
Figure 5. Wrap excess length around perimeter of the Model 3058 Neurostimulator.
2. Check the system integrity before securing the neurostimulator in place.
a. Use the clinician programmer and the product literature packaged with it to confirm
the integrity of the connected system.
Caution: To use the nonsterile clinician programmer in a sterile field, place a
sterile barrier between the patient and the programming head to prevent
infection. Do not sterilize any part of the clinician programmer. Sterilization may
damage the programmer.
Note: The neurostimulator should be in the pocket during system interrogation to
ensure proper readings.
b. Program the stimulation parameters you have selected for your patient according
to the product literature packaged with the programmer.
c. Check the battery status; if applicable, check the electrode impedances to rule out
a short or open circuit.
InterStim Therapy 2016-06-01 English 13
InterStim II Model 3058 Neurostimulator
3. Use the two suture holes in the connector block to secure the neurostimulator to the
muscle fascia with nonabsorbable silk.
Completing the implant procedure
1. Close and dress all incisions.
2. Ensure that a patient programmer and a patient ID card are given to the patient.
Caution: Because the patient programmer is the patient’s only means to adjust
or turn the neurostimulator on or off, the patient must carry a programmer at all
times.
3. Complete the device tracking and patient registration paperwork and return the
documents to Medtronic.
Note: See the Information for Prescribers booklet packaged with this device for
clinician instructions to patients and for information regarding the return of product
documentation.
4. Schedule regular patient follow-up appointments to monitor the condition of the
neurostimulator and to confirm that the programmed parameter values are
appropriate.
Replacing the Model 3058 Neurostimulator
If replacing a Model 3023 Neurostimulator, refer to page 24 of this manual.
1. Open the implant site using normal surgical procedure and carefully remove the
neurostimulator from the subcutaneous pocket.
2. Clean the neurostimulator connector block and lead with sterile water; wipe dry with
sterile gauze.
3. Insert a torque wrench through the prepierced hole in the rubber sealing grommet and
loosen the setscrew by turning it counterclockwise.
4. Gently retract the lead from the neurostimulator connector block.
Caution: Replace any device that shows signs of damage, pitting, or corrosion.
5. Clean and dry the connector block and lead — which must be free of fluids or tissue.
6. Set aside the explanted components for return to Medtronic.
7. Connect the lead and replacement neurostimulator according to the product literature
packaged with those devices.
Note: Increased pocket size may be necessary if replacement neurostimulator uses
an extension.
8. Return explanted devices to Medtronic according to product literature packaged with
those devices.
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InterStim Model 3023 Neurostimulator
InterStim Model 3023 Neurostimulator
Device description
The Medtronic InterStim Model 3023 Neurostimulator is part of a neurostimulation system
for InterStim Therapy.
Package contents
ƒ Neurostimulator
ƒ Torque wrench
ƒ Product literature
Patient registration and identification card
The implant registration form registers the device and creates a record of the device in
Medtronic’s implant data system.
A patient identification card is packaged with this device. Advise the patient to carry the
identification card at all times.
The patient identification card packaged with the device is temporary; a permanent
card will be mailed to the patient when Medtronic receives the implant registration form.
Device specifications
The neurostimulator is a programmable device that accommodates an extension by which
a stimulation program is delivered through a lead.
Refer to Table 4 for shipping, operating, and power-on-reset values. Refer to Table 5 for
physical characteristics. Refer to Table 6 for materials of package components.
InterStim Therapy 2016-06-01 English 15
InterStim Model 3023 Neurostimulator
Table 4. Shipping, operating, and power-on-reset (POR) values for the
Medtronic InterStim Model 3023 Neurostimulator
Programmable Parameters Shipping Operating POR
Amplitude
Normal Resolution
Upper Limit
Lower Limit
Fine Resolution
Upper Limit
Lower Limit
Rate 14 Hz 49 values
0.0 V
0.0 V
0.0 V
---
---
---
100 mV steps
10.5 V maximum
0.0 V minimum
50 mV steps
6.35 V maximum
0.0 V minimum
a
.
0.0 V
0.0 V
0.0 V
---
---
---
31 Hz
b
(from 2.1 to 130 Hz)
Pulse Width 210 μs Increments of 30 μs
Operating
Continuous Continuous or Cycling Continuous
steps
450 μs maximum
60 μs minimum
210 μs
Mode
c
Cycle On/Cycle Off time
SoftStart/Stop
d
0.1 sec 0.1 sec to 24 hr 0.1 sec
Off 1, 2, 4, 8, 15, 30 sec, or
Off
Off
Magnet Control Disabled Enabled/Disabled Enabled
Output On/Off Off On or Off Off
Polarity
Electrode
Number
Case
a
All values are approximate.
b
Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all
electrodes to OFF. POR can occur when there is a temporary fluctuation in battery voltage
(eg, due to electromagnetic interference during electrocautery or defibrillation) or the
battery is depleted. When POR occurs, the serial number is reset to a nominal value and
must be entered with the clinician programmer.
c
Cycle On and Cycle Off time must be greater than or equal to the SoftStart/Stop time.
d
SoftStart/Stop must be less than or equal to the Cycle On and Cycle Off time.
e
If case electrode is positive, electrodes 0-3 may be programmed to Off or – only.
Polarity
–
0
Off
1
Off
2
+
3
e
Off
Off, + or –
Off, + or –
Off, + or –
Off, + or –
Off or +
–
Off
Off
+
Off
16 English 2016-06-01 InterStim Therapy
InterStim Model 3023 Neurostimulator
Table 5. Physical characteristics of the InterStim Model 3023
Neurostimulator
a
.
Description Value
Height 55 mm (2.2 in)
Length 60 mm (2.4 in)
Thickness 10 mm (0.4 in)
Weight 42 g (1.5 oz)
3
Volume 25 cm
(1.5 in3)
External shield Titanium
Power source
b
2.7 Amp hours, 3.7 V
Lithium-thionyl chloride cell
Storage temperature -18 °C to 52 °C (-0 °F to 125 °F)
Serial Number
Radiopaque Identification (ID)
a
All measurements are approximate.
b
The power source is hermetically sealed within the case.
c
The serial number is the radiopaque ID followed by a number. The clinician programmer
displays the entire number beginning with the radiopaque ID.
c
NBV
InterStim Therapy 2016-06-01 English 17
InterStim Model 3023 Neurostimulator
X-Ray identification
Radiopaque identification permits the determination of manufacturer and neurostimulator
model number (Figure 6). With standard x-ray procedures, the code appears as black
characters on white background. The Medtronic symbol identifies Medtronic as the
manufacturer. For the InterStim Model 3023 Neurostimulator, the designated characters
are NBV.
Figure 6. The InterStim Model 3023 Neurostimulator radiopaque code block.
Table 6. Material of components in the Model 3023 package.
Structure Material Material Contacts Human
a
Case
Titanium Yes
Connector Urethane Yes
Grommets, seals Silicone rubber Yes
Setscrews Titanium Yes
Insulation
b
coating
Polymeric insulating film Yes
Adhesive Silicone adhesive Yes
Torque wrench
Handle
Shaft
a
The electronics and power source are hermetically sealed within the case.
b
The etched side of the Model 3023 case is uninsulated and can be programmed as an
indifferent electrode.
Polyetherimide
Stainless steel
Tissue
Yes
Yes
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InterStim Model 3023 Neurostimulator
Instructions for use: Model 3023
Cautions:
ƒ When using sharp instruments near the neurostimulator, be careful to avoid
nicking or damaging the case, the insulation, or the connector block. Damaging
the neurostimulator may require surgical replacement.
ƒ Do not use saline or other ionic fluids at connections, which could result in a
short circuit.
Verifying neurostimulator operation
Before opening the sterile neurostimulator package, use the clinician programmer to
interrogate the neurostimulator and verify neurostimulator battery status and current
settings.
Caution: Do not implant a neurostimulator if it was dropped onto a hard surface from
a height of 30 cm (12 in) or more, because the neurostimulator may be damaged and
fail to operate properly.
Creating a pocket for the Model 3023 Neurostimulator
1. Create a subcutaneous pocket for the neurostimulator by blunt dissection to the
anterior surface of the muscle. The neurostimulator is typically placed in the upper
buttock area.
Notes:
ƒ Abdominal placement is an option with the Model 3023 Neurostimulator. Abdominal
implant instructions are included in the product literature packaged with the leads.
ƒ The Model 3023 Neurostimulator should be placed no deeper than 4 cm (1.5 in)
below the skin and should be parallel to the skin. If the neurostimulator is too deep
or is not parallel to the skin, telemetry may be unsuccessful.
ƒ The uncoated, etched side of the 3023 case can be programmed as an indifferent
electrode. The etched side of the neurostimulator must face away from muscle to
prevent uncomfortable stimulation.
ƒ If the patient has any other neurostimulator, the neurostimulators must be
separated by a minimum 20 cm (8 in).
ƒ The Model 3023 Neurostimulator requires the use of an extension.
InterStim Therapy 2016-06-01 English 19
InterStim Model 3023 Neurostimulator
Cautions:
ƒ The neurostimulator is provided sterile. Do not soak the neurostimulator in
antibiotic solution. Soaking in antibiotic solution can affect lead connections.
ƒ To avoid infection, it is recommended that the neurostimulator implant site
be irrigated with antibiotic solution, and that IV antibiotics be administered
perioperatively. Do not allow the neurostimulator to come into contact with
any non-sterile surface. Do not place on skin. If an infection occurs, it may
require surgical removal of the implanted system.
2. Place the neurostimulator in the pocket to assure proper fit and then remove it. Keep
the neurostimulator sterile and clean.
3. Tunnel from the lead incision site to the neurostimulator pocket. Refer to the product
literature packaged with the lead for detailed tunneling and lead implant instructions.
4. Wipe the proximal end of the lead with sterile gauze and make sure the extension is
dry and clean.
5. Connect and implant the lead and extension according to product literature packaged
with those devices.
6. Connect the extension to the Model 3023 Neurostimulator according to the steps in
“Connecting the extension to the Model 3023 Neurostimulator” in this manual.
Connecting the extension to the Model 3023 Neurostimulator
Caution: Before connecting components, wipe off any body fluids and dry all
connections. Fluids in the connection may result in stimulation at the connection site,
intermittent stimulation, or loss of stimulation.
1. Wipe the extension connector pins with sterile gauze. If necessary, use sterile (United
States Pharmacopeia [USP]) water or a nonionic antibiotic solution, then wipe dry.
2. Make sure the connector block receptacles are dry and clean.
3. Confirm that the encapsulated diagram on the extension has four electrodes matching
the encapsulated diagram on the neurostimulator (Figure 7).
4. Insert the extension connector pins into the neurostimulator until they are fully seated
within the connector block (Figure 7).
Caution: Do not pull the extension or lead body taut when implanted. The
extension and lead are available in different lengths. Select a length that allows
connection without tension.
Note: To retract the setscrews, insert the torque wrench into the self-sealing grommet
and rotate the setscrews counterclockwise; however, do not remove the setscrews
from the connector block (Figure 8).
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InterStim Model 3023 Neurostimulator
Grommet
Caution: Do not insert the extension connector pins into the connector block if
the setscrews are not sufficiently retracted. If the setscrews are not retracted, the
extension connector pins may damage the setscrews and the extension
connector pins will not be seated fully into the connector block.
Encapsulated
Diagram
Figure 7. Insert extension connector pins fully into Model 3023 Neurostimulator
Figure 8. To back out a setscrew from the Model 3023 Neurostimulator, use the torque
Note: The torque wrench must be oriented to the same angle as the setscrew (Figure 8).
wrench and turn the setscrew counterclockwise.
InterStim Therapy 2016-06-01 English 21
connector block.
InterStim Model 3023 Neurostimulator
5. Fully insert the torque wrench into the self-sealing grommet of the connector block and
tighten each setscrew by turning clockwise until the torque wrench clicks (Figure 9).
Cautions:
ƒ Be sure the torque wrench is fully inserted into the self-sealing grommet. If
the torque wrench is not fully inserted, the setscrew may be damaged,
resulting in intermittent or loss of stimulation.
ƒ Before tightening setscrews, ensure that the extension connector pins are
inserted into the connector block to prevent damaging the connector block.
ƒ Verify that each self-sealing grommet is closed after the torque wrench is
withdrawn. If fluid leaks through a grommet seal that is not fully closed, the
patient may experience shocking, burning, or irritation at the neurostimulator
implant location, or intermittent stimulation or loss of stimulation may occur.
ƒ Discard the torque wrench after making all of the connections. The torque
wrench is single-use-only. Its operation cannot be assured if it is used for
multiple surgeries.
Figure 9. Tighten the setscrews in the self-sealing grommet by turning clockwise until the
Note: The torque wrench must be oriented to the same angle as the setscrew
(Figure 9).
22 English 2016-06-01 InterStim Therapy
torque wrench clicks.
InterStim Model 3023 Neurostimulator
Implanting the Model 3023 Neurostimulator
1. Place the neurostimulator into the subcutaneous pocket with the etched identification
side placed outward, away from muscle tissue, and ensure that the extension is not
bent sharply.
Note: The Model 3023 Neurostimulator should be placed no deeper than 4 cm (1.5 in)
below the skin and should be parallel to the skin. If the neurostimulator is too deep or
is not parallel to the skin, telemetry may be unsuccessful.
Cautions:
ƒ Do not place the etched identification side of the neurostimulator facing
inward. Placing the etched side inward could increase the possibility of
skeletomuscular stimulation, which the patient may perceive as twitching or
burning.
ƒ Do not coil excess length in front of the etched identification side of the
neurostimulator. Wrap excess length around the perimeter of the
neurostimulator (Figure 10) to avoid increasing subcutaneous pocket depth,
help minimize potential damage during neurostimulator replacement
surgery, help minimize potential kinking, and minimize interference with
telemetry during programming.
Figure 10. Wrap excess extension around the perimeter of the Model 3023
2. Check the system integrity before securing the neurostimulator in place.
a. Use the clinician programmer and the product literature packaged with it to confirm
the integrity of the connected system.
InterStim Therapy 2016-06-01 English 23
Neurostimulator.
InterStim Model 3023 Neurostimulator
Caution: To use the nonsterile clinician programmer in a sterile field, place a
sterile barrier between the patient and the programming head to prevent
infection. Do not sterilize any part of the clinician programmer. Sterilization may
damage the programmer.
Note: The neurostimulator should be in the pocket during system interrogation to
ensure proper readings.
b. Program the stimulation parameters you have selected for your patient according
to product literature packaged with the programmer.
c. Check the battery status; if applicable, check the electrode impedances to rule out
a short or open circuit.
3. Use the two suture holes in the connector block to secure the neurostimulator to the
muscle fascia with nonabsorbable silk.
Completing the implant procedure
1. Close and dress all incisions.
2. Ensure that a patient programmer and a patient ID card are given to the patient.
Caution: Because the patient programmer is used to adjust or turn the
neurostimulator on or off, the patient must carry a programmer at all times.
Patients implanted with a Model 3023 Neurostimulator may also receive the
optional Model 7452 Control Magnet that is used to turn the neurostimulator on
or off. In order for the control magnet to turn the neurostimulator on or off, the
clinician must enable Magnet Control on the Model 3023 Neurostimulator using
the clinician programmer. Magnet Control can not be enabled or disabled using
the patient programmer.
3. Complete the device tracking and patient registration paperwork and return the
documents to Medtronic.
Note: See the Information for Prescribers booklet packaged with this device for
clinician instructions to patients and for information regarding the return of product
documentation.
4. Schedule regular patient follow-up appointments to monitor the condition of the
neurostimulator and to confirm that the programmed parameter values are
appropriate.
Replacing the Model 3023 Neurostimulator
If replacing a Model 3058 Neurostimulator, refer to page 14 of this manual.
1. Open the implant site using normal surgical procedure and carefully remove the
neurostimulator from the subcutaneous pocket.
2. Clean the neurostimulator connector block and extension connector with sterile water;
wipe lead dry with surgical sponges.
24 English 2016-06-01 InterStim Therapy
InterStim Model 3023 Neurostimulator
3. Insert a torque wrench through each prepierced hole in the rubber sealing grommet
and loosen the setscrews by turning them counterclockwise.
4. Gently retract the extension connector pins from the neurostimulator connector block.
Caution: Replace any device that shows signs of damage, pitting, or corrosion.
5. Clean and dry the connector block and extension connector pins which must be free
of fluids or tissue.
Note: If the replacement neurostimulator does not require the existing extension,
disconnect the extension from the lead. Clean and dry the proximal end of the lead.
Take care not to move the lead when extension is disconnected.
6. Set aside the explanted components for return to Medtronic.
7. Connect the replacement neurostimulator according to the product literature
packaged with that device.
8. Return explanted devices to Medtronic according to product literature packaged with
those devices.
Declaration of conformity
Medtronic declares that the Model 3058 and Model 3023 Neurostimulators are in
conformity with the essential requirements of Directive 90/385/EEC on Active Implantable
Medical Devices.
For additional information, contact the appropriate Medtronic office listed on the inside
back cover of this manual.
InterStim Therapy 2016-06-01 English 25
InterStim Model 3023 Neurostimulator
Control magnet
The Medtronic Model 7452 Control Magnet allows your patient to turn the Model 3023
Neurostimulator on or off. The control magnet is not used with the Model 3058
Neurostimulator.
When the control magnet on/off control circuit is enabled, applying the flat, rectangular
edge of the control magnet over the implant site for 1 to 2 seconds (Figure 11) and then
removing it turns the neurostimulator on or off.
Neurostimulator
Control Magnet
Figure 11. Control magnet properly positioned over the Model 3023 Neurostimulator.
If SoftStart/Stop is in use, turning the Model 3023 Neurostimulator on causes the amplitude
to ramp up from zero to the selected output amplitude. Turning the neurostimulator off
causes the amplitude to ramp down to zero again. The ramp time is set by the SoftStart/
Stop parameters.
The control magnet on/off control circuit does not affect programmed parameters; when the
output is turned on with the control magnet, the output resumes its previously programmed
waveform and stimulation mode.
For patients who live or work in electrically noisy environments, random on or off switching
may be a problem. If on or off switching occurs, you can disable the magnet control circuitry
with a command to the neurostimulator from the clinician programmer. Detailed instructions
on disabling this feature are provided in the product literature packaged with the
programmer software.
Note: The patient with a Model 3023 Neurostimulator may carry the optional control
magnet to turn the neurostimulator on or off.
The patient programmer will still operate the neurostimulator because it uses a different
circuit than the control magnet to turn the neurostimulator on or off. The magnet control
circuit can be enabled again with another command from the clinician programmer, if
desired.
26 English 2016-06-01 InterStim Therapy
InterStim Model 3023 Neurostimulator
Caution: Because the patient programmer is used to adjust or turn on or off the
neurostimulator, the patient must carry a programmer at all times. Patients implanted
with a Model 3023 Neurostimulator may also receive the optional Model 7452 Control
Magnet that is used to turn the neurostimulator on or off. In order for the control
magnet to turn the neurostimulator on or off, the clinician must enable Magnet Control
on the Model 3023 Neurostimulator using the clinician programmer. Magnet Control
can not be enabled or disabled using the patient programmer.
InterStim Therapy 2016-06-01 English 27
Contacts:
Asia: Medtronic International Ltd.
Tel. 02919-1362
Fax 02907-3998
Asia: Medtronic Asia Ltd.
Tel. (02)-548-1148
Fax (02)-518-4786
Australia: Medtronic Australasia Pty. Ltd.
97 Waterloo Road
North Ryde, NSW 2113
Australia
Tel. +61-2-9857-9000
Fax +61-2-9878-5100
Toll-free 1-800-668-6700
Austria: Medtronic Österreich GmbH
Tel. 01-240440
Fax 01-24044-100
Belgium: Medtronic Belgium S.A.
Tel. 02-456-0900
Fax 02-460-2667
Canada: Medtronic of Canada Ltd.
Tel. (1905) 460-3800
Fax (1905) 826-6620
Czech Republic: Medtronic Czechia s.r.o.
Tel. 2-965-795-80
Fax 2-965-795-89
Denmark: Medtronic Danmark A/S
Tel. 45-32-48-18-00
Fax 45-32-48-18-01
Finland: Medtronic Finland Oy/Ltd
Tel. (09)-755-2500
Fax (09)-755-25018
France: Medtronic France S.A.S.
Tel. 01-5538-1700
Fax 01-5538-1800
Germany: Medtronic GmbH,
Tel. (02159)-81490
Fax (02159)-8149100
Greece: Medtronic Hellas S.A.
Tel. 210-67-79-099
Fax 210-67-79-399
Hungary: Medtronic Hungária Kft.
Tel. 1-889-06-00
Fax 1-889-06-99
Ireland: Medtronic Ireland Ltd.
Tel. (01)-890-6522
Fax (01)-890-7220
Italy: Medtronic Italia SpA
Tel. 02-241371
Fax 02-241381
Tel. 06-328141
Fax 06-3215812
Japan: Medtronic Japan
Tel. 03-6430-2016
Fax 03-6430-7110
Latin America: Medtronic, Inc.
Tel. (1305)-500-9328
Fax (1786)-709-4244
Norway: Medtronic Norge AS
Tel. 067-10-32-00
Fax 067-10-32-10
Poland: Medtronic Poland Sp. z.o.o.
Tel. (022)-465-69-00
Fax (022)-465-69-17
Portugal: Medtronic Portugal, Lda.
Tel. 21-724-5100
Fax 21-724-5199
Russia: Medtronic Russia
Tel. (8495) 580-7377
Fax (8495) 580-7378
Slovakia: Medtronic Slovakia, o.z.
Tel. 0268 206 911
Fax 0268 206 999
Spain: Medtronic Ibérica, S.A.
Tel. 91-625-0400
Fax 91-650-7410
Sweden: Medtronic AB
Tel. 08-568-585-00
Fax 08-568-585-01
Switzerland: Medtronic (Schweiz) AG
Tel. 031-868-0100
Fax 031-868-0199
The Netherlands: Medtronic B.V.
Tel. (045)-566-8000
Fax (045)-566-8668
U.K.: Med
tronic U.K. Ltd.
Tel. 01923-212213
Fax 01923-241004
USA: Medtronic, Inc.
Tel. (1763) 505-5000
Fax (1763) 505-1000
Toll-free (1800) 328-0810
Manufacturer
EC
REP
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432-5604 USA
www.medtronic.com
Tel. 1-763-505-5000
Fax 1-763-505-1000
Authorized Representative
in the European Community
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel. 31-45-566-8000
Fax 31-45-566-8668
Europe/Africa/Middle East
Headquarters
Medtronic International Trading Sàrl
Route du Molliau 31
Case Postale 84
CH-1131 Tolochenaz
Switzerland
www.medtronic.eu
Tel. 41-21-802-7000
Fax 41-21-802-7900
Asia-Pacific
Medtronic International Ltd.
Suite 1106-11, 11/F, Tower 1, The Gateway,
25 Canton Road, Tsimshatsui
Kowloon
Hong Kong
Tel. 852-2919-1362
Fax 852-2907-3998
Contacts for specific countries are listed inside this cover.
© Medtronic, Inc. 2016
All Rights Reserved
*MA12231A024*
MA12231A024 Rev A
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