Medtronic TM90P01 Reference Guide

System eligibility, battery longevity,
specifications

InterStim™ Systems

Reference manual

! USA

  Rx only

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are trademarks of their respective owners. All other brands are trademarks of a
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2 English  System eligibility, battery longevity, specifications 2021-11-01

Table of contents

Introduction 5

System eligibility 6

Maximum amplitude 8

Neurostimulator replacement 9

Replacing a Model 3023 Neurostimulator with a Model 3058 Neurostimulator 9

Suggestions for maximizing battery longevity (InterStim Model 3023, InterStim II
Model 3058, and InterStim X Model 97800 Neurostimulators) 11

Cycling (Model 3023 and Model 3058 Neurostimulators only) 11
Example: Impact of cycling intervals on InterStim II Model 3058 battery
longevity 11

Battery longevity (InterStim Micro Model 97810 Neurostimulator) 13

Estimating recharge interval (InterStim Micro Model 97810 Neurostimulator) 14

Battery longevity (InterStim II Model 3058 and InterStim X Model 97800
Neurostimulators) 15

Battery longevity estimation: Model 97800 InterStim X Neurostimulator 15
Battery longevity estimation: Model 3058 InterStim II Neurostimulator 16
Example: Model 3058 Neurostimulator 21

System eligibility, battery longevity, specifications 2021-11-01  English 3

Information available for the system:

The information for prescribers manual provides information
about contraindications, warnings, precautions, adverse events,
sterilization, patient selection, individualization of treatment, and
component disposal. For customers in Japan, the appropriate
package insert provides information about safety,
contraindications, warnings, precautions, and adverse events.

The indications sheet provides information about indications and
related information. For customers in Japan, the appropriate
package insert provides information about indications.

The system eligibility, battery longevity, specifications manual
provides information about neurostimulator selection, battery
longevity calculations, and battery characteristics.

The system overview and compatibility insert provides
information about component compatibility.

MRI guidelines provide information about any MRI conditions and
MRI-specific contraindications, warnings, and precautions for MRI
scans with the neurostimulation system.

Product manuals, such as programming guides, recharging
guides, and implant manuals provide device descriptions,
package contents, device specifications, product-specific
warnings and precautions, and instructions for use.

! USA

The clinical summary provides information about the

clinical study results for the neurostimulation system.

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Introduction

This manual provides information about system eligibility, battery longevity and
specifications.

System eligibility describes how to use test stimulation to aid in neurostimulator

▪

selection.
Battery longevity and specifications provides information for use in estimating

▪

recharge interval (the number of days that a rechargeable neurostimulator will
provide stimulation at programmed settings before requiring recharge), and
information for use in estimating battery longevity (the number of months or years
that a neurostimulator is expected to provide stimulation at programmed settings
before requiring replacement). It also provides information about programming
choices that affect recharge interval and battery longevity.

Some product models described in this manual are not available in all geographies.

System eligibility, battery longevity, specifications 2021-11-01  English 5

System eligibility

Prior to a new neurostimulator implant or a replacement neurostimulator implant, it is
important that the clinician ensures that a chosen neurostimulation system is appropriate
for the patient.

The InterStim™ Micro Model 97810 Neurostimulator is a rechargeable neurostimulator.
The clinician should assess the ability and willingness of a patient to perform recharging
tasks as part of establishing eligibility for the InterStim Micro system.

The InterStim II Model 3058 Neurostimulator and InterStim X Model 97800
Neurostimulator are not rechargeable. When the battery is depleted, the neurostimulator
must be replaced.

For first implant of a new lead or a new neurostimulation system, the first step in
determining system eligibility is to establish satisfactory patient response during a
therapy evaluation procedure. Refer to the System Overview and Compatibility Insert for
information on compatibility among components.

When using the Verify™ Model 3531 External Neurostimulator, refer to Table 1 for
guidance on determining whether the InterStim Micro Model 97810, InterStim X Model
97800 Neurostimulator, or the InterStim II Model 3058 Neurostimulator is an appropriate
device for the patient.

Table 1. Verify Model 3531 External Neurostimulator therapeutic amplitude and

corresponding system eligibility for the InterStim Micro Model 97810, InterStim X Model

97800 or InterStim II Model 3058 Neurostimulators

Therapeutic amplitude System eligibility

Less than 2 mA Settings achievable on the:

InterStim Micro Model 97810 Neurostimulator

•
InterStim X Model 97800 Neurostimulator

•

•

InterStim II Model 3058 Neurostimulator

6 English  System eligibility, battery longevity, specifications 2021-11-01

Table 1. Verify Model 3531 External Neurostimulator therapeutic amplitude and

corresponding system eligibility for the InterStim Micro Model 97810, InterStim X Model

97800 or InterStim II Model 3058 Neurostimulators (continued)

Therapeutic amplitude System eligibility

2 to 3 mA Settings achievable on the:

InterStim Micro Model 97810 Neurostimulator

•
InterStim X Model 97800 Neurostimulator

•

•

InterStim II Model 3058 Neurostimulator

May require more frequent neurostimulator replacements
(Model 3058 or Model 97800) or recharge (Model 97810)
due to high energy consumption.

Consider adjusting lead placement to obtain therapeutic

•

response at a lower amplitude to achieve lower energy
consumption.

To optimize battery longevity of the InterStim X Model

•

97800, InterStim II Model 3058, or InterStim Model 3023
Neurostimulator, refer to the information provided in
"Suggestions for maximizing battery longevity (InterStim
Model 3023, InterStim II Model 3058, and InterStim X
Model 97800 Neurostimulators)" on page 11.

To optimize recharge interval for the InterStim Micro

•

Model 97810 Neurostimulator, refer to the information
provided in Table 5 on page 14.

Greater than 3 mA Settings achievable on the:

InterStim Micro Model 97810 Neurostimulator

•

•

InterStim X Model 97800 Neurostimulator

Settings may not be achievable on the InterStim II Model
3058 Neurostimulator.

May require more frequent neurostimulator replacements
(Model 3058 or Model 97800) or recharge (Model 97810)
due to high energy consumption.

Consider adjusting lead placement to obtain therapeutic

•

response at a lower amplitude.

Consider adjusting electrode configuration to obtain

•

therapeutic response at a lower amplitude.

When using the Model 3625 Test Stimulator, use Table 2 to determine whether the
patient is eligible to use the InterStim II Model 3058 Neurostimulator. To use Table 2,
locate the intersection of the screening rate and pulse width. The value displayed at this
intersection reflects an amplitude that, if programmed on the Model 3625 Test Stimulator,
will produce an output equivalent to the maximum output of an InterStim II Model 3058

System eligibility, battery longevity, specifications 2021-11-01  English 7

Neurostimulator that is programmed to its maximum amplitude, and to that rate and pulse
width combination.

If the screening amplitude exceeds the maximum amplitude value provided in

▪

Table 2 for a rate and pulse width combination, reduce the rate until you are at or
below a rate/pulse width/amplitude combination displayed in the table.
If the screening pulse width value is greater than 450 microseconds, reduce the

▪

pulse width value on the screener to 450 microseconds and gradually increase
amplitude to confirm satisfactory stimulation.
If the screening rate is greater than 130 Hertz, reduce the rate value on the screener

▪

to 130 Hertz and confirm satisfactory stimulation.
If satisfactory stimulation cannot be achieved within the parameters provided in

▪

Table 2, the InterStim II Model 3058 Neurostimulator may not be an appropriate
device for the patient.
If the screening amplitude is close to the maximum amplitude indicated in Table 2,

▪

consider reducing the rate to allow future increases in amplitude.

Maximum amplitude

Table 2. Model 3625 Test Stimulator settings for use in therapeutic evaluation of the

maximum amplitude of the InterStim II Model 3058 Neurostimulator

Screening pulse width (microseconds)

Screening rate
(Hz)

130 7.7 7.7 7.7 7.0 6.0 Amplitude

120 7.7 7.7 7.7 7.0 6.0

110 7.7 7.7 7.7 7.0 6.0

100 7.7 7.7 7.7 7.0 6.1

90 7.8 7.8 7.8 7.0 6.2

80 7.8 7.8 7.8 7.1 6.2

70 7.8 7.8 7.8 7.1 6.2

60 7.8 7.8 7.8 7.1 6.3

50 7.8 7.8 7.8 7.2 6.3

40 7.8 7.8 7.8 7.2 6.3

30 7.8 7.8 7.8 7.3 6.4

≤ 20 7.8 7.8 7.8 7.3 6.4

8 English  System eligibility, battery longevity, specifications 2021-11-01

60 150 210 330 450

(V)