Medtronic A710 Reference Guide
System Eligibility
Battery Longevity
Neurostimulation systems for pain
Reference manual
! USA
Rx only
Explanation of symbols on product and package labeling.
Conformité Européenne (European Conformity). This symbol means that the device fully
complies with applicable European Directives.
Manufacturer
EC
! USA
REP
Authorized Representative in the European Community
For USA audiences only
System Eligibility, Battery Longevity 2021-02-15 English 3
Medtronic, Medtronic logo, and Further, Together are trademarks of Medtronic. AdaptiveStim™,
Intellis™, IntelliStim™, InterStim™, Itrel™, Pisces-Quad™, PrimeAdvanced™, Restore™,
RestoreAdvanced™, RestorePrime™, RestoreSensor™, RestoreUltra™, Sequentia™, SureScan™,
Vanta™, and Vectris™ are trademarks of a Medtronic company.
4 English System Eligibility, Battery Longevity 2021-02-15
Table of contents
System eligibility 7
Trial stimulation devices 7
Trial stimulation for Vanta with AdaptiveStim™ Technology or Sequentia LT using the Model 97725
Wireless External Neurostimulator 10
Trial stimulation for Intellis or Intellis with AdaptiveStim™ Technology using the Model 97725 Wireless
External Neurostimulator 10
Trial stimulation for RestoreSensor, RestoreSensor SureScan MRI, or RestoreUltra SureScan MRI
using the Model 97725 Wireless External Neurostimulator 11
Trial stimulation for PrimeAdvanced, PrimeAdvanced SureScan MRI, Restore, RestoreAdvanced
SureScan MRI, or RestorePrime using the Model 97725 Wireless External Neurostimulator 11
Trial stimulation for Itrel 4 using the Model 97725 Wireless External Neurostimulator 12
Trial stimulation for Intellis or Intellis with AdaptiveStim™ Technology using the Model 37022 External
Neurostimulator 12
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 and battery longevity manual describes programming considerations
and provides battery longevity information to aid in the appropriate neurostimulator selection.
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.
System Eligibility, Battery Longevity 2021-02-15 English 5
Trial stimulation for RestoreSensor, RestoreSensor SureScan MRI, or RestoreUltra SureScan MRI
using the Model 37022 External Neurostimulator 12
Trial stimulation for PrimeAdvanced, PrimeAdvanced SureScan MRI, Restore, RestoreAdvanced
SureScan MRI, or RestorePrime using the Model 37022 External Neurostimulator 13
Trial stimulation for Itrel 4 using the Model 37022 External Neurostimulator 14
Trial stimulation for PrimeAdvanced, PrimeAdvanced SureScan MRI, Restore, RestoreAdvanced
SureScan MRI, or RestorePrime using the Model 37021 External Neurostimulator 14
Battery longevity and maintenance 16
Intellis and Intellis with AdaptiveStim™ Technology 16
RestoreSensor, RestoreSensor SureScan MRI, and RestoreUltra SureScan MRI 16
Restore and RestoreAdvanced SureScan MRI 17
PrimeAdvanced, PrimeAdvanced SureScan MRI, RestorePrime, Sequentia LT, and Vanta with
AdaptiveStim™ Technology 19
Estimating battery longevity for Vanta with AdaptiveStim™ Technology or Sequentia LT 20
Estimating battery longevity for PrimeAdvanced, PrimeAdvanced SureScan MRI, and
RestorePrime 20
Itrel 4 27
Estimating battery longevity for Itrel 4 27
Estimating battery longevity examples 32
Example 1: PrimeAdvanced, PrimeAdvanced SureScan MRI, or RestorePrime Neurostimulator
and 4 programs with low-impedance leads 32
Example 2: Itrel 4 Neurostimulator with standard-impedance lead 34
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System eligibility
A trial or test stimulation period is used to determine if a new or replacement Medtronic neurostimulation
system can deliver adequate paresthesia to a patient. With the trial stimulation devices designed to test
for a number of implantable neurostimulators, make sure that the number of programs and parameter
settings used during trial stimulation are evaluated against the features of the neurostimulators
considered for implant.
This approach ensures:
the number of programs needed for therapy does not exceed the ability of the neurostimulator.
▪
the parameter settings on the trial stimulation device are converted if the trial stimulation device
▪
accepts:
pulse width or rate settings that are higher than the settings accepted by a specific implantable
–
neurostimulator.
amplitude (intensity) settings, at a specific rate and pulse width, which exceed the maximum
–
amplitude setting a specific implantable neurostimulator can use to produce paresthesia. Even if
the amplitude setting is accepted by the implantable neurostimulator, the amplitude output will
not exceed the maximum amplitude listed in the table.
Notes:
When choosing a replacement neurostimulator, remember that all neurostimulators do not have
▪
identical features.
The Itrel 4 Models 37703 and 37704 Neurostimulators are the only Medtronic neurostimulators for
▪
pain with a unipolar mode. When replacing an Itrel 4 Neurostimulator with another model of
Medtronic neurostimulator, ensure that unipolar stimulation is not required.
Use trial stimulation leads (also called trial leads) for trial stimulation that are the same impedance
▪
type (ie, low impedance, standard impedance) as the leads intended to be implanted later with the
fully implanted neurostimulation system.
Using the same impedance-type leads for trial stimulation as the lead intended at the time of full
system implant allows for more accurate longevity estimates for the implanted neurostimulator.
For instance, using a low impedance lead for trial stimulation and later implanting a standard
impedance lead for the fully implanted system may require more energy use. Furthermore, patients
who required high parameter settings during trial stimulation could require parameter values that
exceed the maximum system capability of their fully implanted neurostimulation system.
Trial stimulation devices
The Model 97725 Wireless External Neurostimulator, Model 37022 External Neurostimulator, and Model
37021 External Neurostimulator can each test for more than 1 implantable neurostimulator.
System Eligibility, Battery Longevity 2021-02-15 English 7
Use Table 1–Table 3 to determine:
which trial stimulation devices can test for which neurostimulator.
▪
before trial stimulation starts, how to configure program settings for the external neurostimulator if
▪
you know which implantable neurostimulator the patient is likely to receive.
at the end of trial stimulation, which implantable neurostimulators to consider based on the number
▪
of programs that trial stimulation results required and the stimulation settings the patient found most
effective.
If you are using the tables to help configure programs, find the name of the implantable neurostimulator in
the Implantable neurostimulator column, then set up programs for trial stimulation according to the
program setting guidelines in the corresponding Program setting guidelines column.
If you are using the table to select an implantable neurostimulator at the end of the trial, look at the
Program setting guidelines column and find the number of programs and the program settings that are
most similar to the ones the patient used during trial stimulation. Then look at the corresponding
Implantable neurostimulator column to see which implantable neurostimulator can deliver those program
settings.
Table 1. The Model 97725 Wireless External Neurostimulator (ENS) and implantable neurostimulators (INS)
Implantable
neurostimulator
Vanta with AdaptiveStim™
Technology
Program setting guidelines Refer to
•
You must have a pulse width of ≤450 μs and a program rate of
≤130 Hz.
page 10
Sequentia LT •
Intellis
Intellis with AdaptiveStim™
Technology
RestoreSensor
RestoreSensor SureScan
MRI
RestoreUltra SureScan MRI
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You must have a pulse width of ≤450 μs and a program rate of
≤130 Hz.
• Electrode redistribution and IntelliStim are not available.
You may have only 1 program.
•
You may configure 2–8 electrodes.
•
•
No special program configuration considerations required.
Electrode redistribution and IntelliStim are not available for the
•
Intellis Model 97716 Neurostimulator.
•
Electrode redistribution and IntelliStim are not available for these
implantable neurostimulators.
• All active programs must have the same rate.
At least 1 active program may have a pulse width >450 µs and the
•
rate that applies to all the active programs may be >130 Hz.
page 10
page 10
page 11
Table 1. The Model 97725 Wireless External Neurostimulator (ENS) and implantable neurostimulators (INS) (continued)
Implantable
Program setting guidelines Refer to
neurostimulator
PrimeAdvanced
PrimeAdvanced SureScan
MRI
RestoreAdvanced SureScan
MRI
Restore
RestorePrime
•
Electrode redistribution and IntelliStim are not available for these
implantable neurostimulators.
• All active programs must have the same rate.
•
If trial stimulation results require 1–2 programs, you must have a
pulse width of ≤450 µs and a program rate of ≤130 Hz.
• If trial stimulation results require 3 programs, you must have a pulse
width of ≤450 µs and a program rate of ≤85 Hz.
page 12
• If trial stimulation results require 4 programs, you must have a pulse
width of ≤450 µs and a program rate of ≤65 Hz.
Itrel 4 •
Table 2. The Model 37022 External Neurostimulator (ENS) and implantable neurostimulators (INS)
Implantable
neurostimulator
Intellis
Intellis with AdaptiveStim™
Technology
RestoreSensor
RestoreSensor SureScan
MRI
RestoreUltra SureScan MRI
PrimeAdvanced
PrimeAdvanced SureScan
MRI
RestoreAdvanced SureScan
MRI
Restore
RestorePrime
Electrode redistribution and IntelliStim are not available for these
page 12
implantable neurostimulators.
• All active programs must have the same rate.
You must have a pulse width of ≤450 µs and a program rate of
•
≤130 Hz.
•
You may have only 1 program.
Program setting guidelines Refer to
•
You may have 1–4 programs. page 12
•
You may have 1–4 programs. page 12
•
If trial stimulation results require 1–2 programs, you must have a
page 13
maximum pulse width of ≤450 µs and a maximum program rate of
≤130 Hz.
• If trial stimulation results require 3 programs, you must have a
maximum pulse width of ≤450 µs and a maximum program rate of
≤85 Hz.
• If trial stimulation results require 4 programs, you must have a
maximum pulse width of ≤450 µs and a maximum program rate of
≤65 Hz.
Itrel 4 •
You may have 1 program. page 14
System Eligibility, Battery Longevity 2021-02-15 English 9
Table 3. The Model 37021 External Neurostimulator (ENS) and implantable neurostimulators (INS)
Implantable
neurostimulator
PrimeAdvanced
PrimeAdvanced SureScan
MRI
RestoreAdvanced SureScan
MRI
Restore
RestorePrime
Program setting guidelines Refer to
•
You may have 1–4 programs. page 14
Trial stimulation for Vanta with AdaptiveStim™
Technology or Sequentia LT using the Model 97725
Wireless External Neurostimulator
If you are considering implanting a Vanta with AdaptiveStim™ Technology Model 977006 or Sequentia
LT Model 977005 Neurostimulator, you may use the Model 97725 Wireless External Neurostimulator to
deliver trial stimulation.
For these implantable neurostimulators, the maximum settings available are 450 μs for pulse width and
130 Hz for program rate.
For the Sequentia LT Model 977005 Neurostimulator:
electrode redistribution and IntelliStim are not available.
▪
you may have only one program.
▪
you may configure 2–8 electrodes.
▪
Trial stimulation for Intellis or Intellis with
AdaptiveStim™ Technology using the Model 97725
Wireless External Neurostimulator
If you are considering implanting an Intellis with AdaptiveStim™ Technology Model 97715 or Intellis
Model 97716 Neurostimulator, you may use the Model 97725 Wireless External Neurostimulator to
deliver trial stimulation. There are no special program configuration considerations.
Note: Electrode redistribution and IntelliStim are not available for the Intellis Model 97716
Neurostimulator.
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Trial stimulation for RestoreSensor, RestoreSensor
SureScan MRI, or RestoreUltra SureScan MRI using
the Model 97725 Wireless External Neurostimulator
If you are considering implanting any of the following neurostimulators, you may use the Model 97725
External Neurostimulator to deliver trial stimulation:
• RestoreSensor Model 37714
RestoreSensor SureScan MRI Model 97714
•
For these implantable neurostimulators:
the rate must be the same across active programs.
▪
electrode redistribution and IntelliStim are not available.
▪
At least one active program may have a pulse width greater than 450 µs and the rate that applies to all
the active programs may be greater than 130 Hz.
•
RestoreUltra SureScan MRI Model 97712
Trial stimulation for PrimeAdvanced, PrimeAdvanced
SureScan MRI, Restore, RestoreAdvanced SureScan
MRI, or RestorePrime using the Model 97725 Wireless
External Neurostimulator
If you are considering implanting any of the following neurostimulators, you may use the Model 97725
External Neurostimulator to deliver trial stimulation:
• PrimeAdvanced Model 37702
PrimeAdvanced SureScan MRI Model 97702
•
Restore Model 37711
•
For these implantable neurostimulators:
the rate must be the same across active programs.
▪
electrode redistribution and IntelliStim are not available.
▪
For PrimeAdvanced, PrimeAdvanced SureScan MRI, and RestoreAdvanced SureScan MRI, the
maximum settings available are 450 µs for pulse width and 130 Hz for rate for 1 to 2 programs; 450 µs for
pulse width and 85 Hz for rate for 3 programs; and 450 µs for pulse width and 65 Hz for rate for 4
programs.
•
RestoreAdvanced SureScan MRI Model 97713
RestorePrime Model 37701
•
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