Medtronic A710 Reference Guide

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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

! 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.

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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.

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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.

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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 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

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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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Trial stimulation for Itrel 4 using the Model 97725 Wireless External Neurostimulator

If you are considering implanting an Itrel 4 Model 37703 or Model 37704 Neurostimulator, you can use the Model 97725 Wireless External Neurostimulator to deliver trial stimulation.

For these implantable neurostimulators:

the rate must be the same across active programs.

▪

electrode redistribution and IntelliStim are not available.

▪

the maximum settings available are 450 μs for pulse width and 130 Hz for rate for 1 program.

▪

While delivering trial stimulation, make sure that the number of programs used on the trial stimulation device does not exceed the number of programs available on the neurostimulator being considered for implant.

Higher pulse width and rates decrease the programmable amplitude in Itrel 4 neurostimulators.

Trial stimulation for Intellis or Intellis with AdaptiveStim™ Technology using the Model 37022 External Neurostimulator

If you are considering implanting an Intellis with AdaptiveStim™ Technology Model 97715 or Intellis Model 97716 Neurostimulator, you may use the Model 37022 External Neurostimulator to deliver trial stimulation.

You may have 1–4 active programs. There are no other special program configuration considerations.

Trial stimulation for RestoreSensor, RestoreSensor SureScan MRI, or RestoreUltra SureScan MRI using the Model 37022 External Neurostimulator

If you are considering implanting any of the following neurostimulators, you may use the Model 37022 External Neurostimulator to deliver trial stimulation:

• RestoreSensor Model 37714

•

RestoreSensor SureScan MRI Model 97714

The RestoreSensor, RestoreSensor SureScan MRI, and RestoreUltra SureScan MRI Neurostimulation Systems may have limited stimulation adjustments available if the therapy parameters are near the high

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RestoreUltra SureScan MRI Model 97712

•

output interlocks. If the trial stimulation is near the high output interlocks, approximate the trial stimulation effect by lowering the amplitude setting and adjusting 1 or more of the following:

Decrease the rate

▪

Increase the pulse width(s)

▪

Change the selected electrodes

▪

Reposition the lead(s)

▪

Trial stimulation for PrimeAdvanced, PrimeAdvanced SureScan MRI, Restore, RestoreAdvanced SureScan MRI, or RestorePrime using the Model 37022 External Neurostimulator

If you are considering implanting any of the following neurostimulators, you may use the Model 37022 External Neurostimulator to deliver trial stimulation:

• PrimeAdvanced Model 37702

•

PrimeAdvanced SureScan MRI Model 97702 Restore Model 37711

•

The clinician programmer will not display the Restore Neurostimulator or RestorePrime Neurostimulator in the longevity estimate results.

RestoreAdvanced SureScan MRI Model 97713

•

RestorePrime Model 37701

However, if the longevity test is successful for the PrimeAdvanced, PrimeAdvanced SureScan MRI, or RestoreAdvanced SureScan MRI Neurostimulator, the Restore Neurostimulator or RestorePrime Neurostimulator may be used.

The PrimeAdvanced, PrimeAdvanced SureScan MRI, and RestoreAdvanced SureScan MRI Neurostimulation Systems may have limited stimulation adjustments available if the amplitude exceeds

9.5 V. If the trial stimulation exceeds 9.5 V, approximate similar stimulation by lowering the amplitude setting and adjusting 1 or more of the following:

Decrease the rate

▪

Increase the pulse width(s)

▪

Change the selected electrodes

▪

Reposition the lead(s)

▪

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particular setting is available to the neurostimulator. If the setting is not available, the clinician programmer indicates that the setting is not applicable to the neurostimulator.

Trial stimulation for Itrel 4 using the Model 37022 External Neurostimulator

If you are considering implanting an Itrel 4 Model 37703 or Model 37704 Neurostimulator, you may use the Model 37022 External Neurostimulator to deliver trial stimulation.

The Itrel 4 Neurostimulation System may have limited stimulation adjustments available if the therapy parameters exceed 9.5 V or are near the high output interlocks. If the trial stimulation exceeds 9.5 V or is near the high output interlocks, approximate the trial stimulation effect by lowering the amplitude setting and adjusting 1 or more of the following:

Decrease the rate

▪

Increase the pulse width(s)

▪

Change the selected electrodes

▪

Reposition the lead(s)

▪

Table 4. Trial stimulation maximum amplitude (V) for Itrel 4 using the Model 37022 External neurostimulator

No. of programs intended for use

1 50 10.5 V 10.5 V 10.5 V 10.5 V 10.5 V 10.5 V

1 70 10.5 V 10.5 V 10.5 V 10.5 V 10.5 V 10.0 V

1 100 10.5 V 10.5 V 10.5 V 10.5 V 10.5 V 9.3 V

1 125 10.5 V 10.5 V 10.5 V 10.5 V 10.15 V 8.75 V

Rate (Hz) Pulse width (µs)

60 120 180 240 330 450

Note: The lead configuration is 1x4 and only one program is defined.

Trial stimulation for PrimeAdvanced, PrimeAdvanced SureScan MRI, Restore, RestoreAdvanced SureScan MRI, or RestorePrime using the Model 37021 External Neurostimulator

If you are considering implanting any of the following neurostimulators, you may use the Model 37021 External Neurostimulator to deliver trial stimulation:

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• PrimeAdvanced Model 37702

PrimeAdvanced SureScan MRI Model 97702

•

Restore Model 37711

RestoreAdvanced SureScan MRI Model 97713

•

RestorePrime Model 37701

•

The external neurostimulator and these implantable neurostimulators produce comparable paresthesia when the same number of programs are set to the same parameter settings.

The PrimeAdvanced, PrimeAdvanced SureScan MRI, RestoreAdvanced SureScan MRI, Restore, and RestorePrime Neurostimulation Systems may have limited stimulation adjustments available if the amplitude exceeds 9.5 V. If the trial stimulation exceeds 9.5 V, approximate similar stimulation by lowering the amplitude setting and adjusting 1 or more of the following:

Decrease the rate

▪

Increase the pulse width(s)

▪

Change the selected electrodes

▪

Reposition the lead(s)

▪

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Battery longevity and maintenance

The following neurostimulators have rechargeable batteries:

• Intellis

Intellis with AdaptiveStim™ Technology

•

Restore RestoreAdvanced SureScan MRI

•

The following neurostimulators have nonrechargeable batteries:

• Itrel 4

PrimeAdvanced

•

PrimeAdvanced SureScan MRI

Intellis and Intellis with AdaptiveStim™ Technology

The Intellis with AdaptiveStim™ Technology Model 97715 and Intellis Model 97716 Neurostimulator rechargeable battery requires a recharge session at least once per year for the battery to reach maximum longevity.

The amount of time before the neurostimulator battery requires charging is affected by the number of active programs and the stimulation settings in each program. The majority of patients that use rate settings around 60 Hz can expect to recharge their neurostimulators every 4 or more days. Higher stimulation settings will require more frequent recharging sessions. Patients should define a recharge schedule that meets their individual needs while maintaining a charge level that is capable of sustaining programmed stimulation settings.

RestoreSensor

•

RestoreSensor SureScan MRI

•

RestoreUltra SureScan MRI

RestorePrime

•

Sequentia LT

•

Vanta with AdaptiveStim™ Technology

The Intellis with AdaptiveStim™ Technology Model 97715 and Intellis Model 97716 Neurostimulators will provide at least 9 years of operation before replacement is recommended. Over time, the neurostimulator battery will need more frequent recharges. Like all rechargeable batteries, use over time and repeated recharge cycles reduce the maximum charge capacity of the neurostimulator battery.

When the neurostimulator reaches 9 years of service, the elective replacement indicator (ERI) message will display on the Model A710 Intellis clinician programmer application and on the Model 97745 Controller screen. At this time, the neurostimulator should be replaced.

RestoreSensor, RestoreSensor SureScan MRI, and RestoreUltra SureScan MRI

The following neurostimulators have a rechargeable battery and require that a charge be maintained in order for the battery to reach maximum longevity:

RestoreSensor Model 37714

▪

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RestoreSensor SureScan MRI Model 97714

▪

RestoreUltra SureScan MRI Model 97712

▪

The amount of time before the battery requires charging is affected by patient use, the number of programs, stimulation settings in each program, and the use of cycling. All these factors are variable and may result in increased frequency of recharge sessions or reduced battery longevity. Monitor your patient's battery charge level regularly. The majority of patients can expect to recharge their neurostimulators every 10 days. Higher stimulation settings will require more frequent recharging sessions. Patients should define a recharge schedule that meets their individual needs while maintaining a charge level that is capable of sustaining programmed stimulation settings.

The battery for the RestoreSensor, RestoreSensor SureScan MRI, and RestoreUltra SureScan MRI Neurostimulators will provide 9 years of operation. Over time, the neurostimulator battery will need more frequent recharges. Like all rechargeable batteries, use over time and repeated recharge cycles reduce the maximum charge capacity of the neurostimulator battery.

When the neurostimulator battery reaches 8 years of operation, the elective replacement indicator (ERI) message is displayed in the Observations box on the clinician programmer screen or on the patient programmer screen. A replacement neurostimulator is needed within 6 months. At 9 years, the end of service (EOS) message is displayed in the Observations box on the clinician programmer screen or on the patient programmer screen. At this time, the neurostimulator no longer provides stimulation and a replacement neurostimulator is needed.

Restore and RestoreAdvanced SureScan MRI

The rechargeable battery for the following neurostimulators requires that a charge be maintained in order for the battery to reach maximum longevity:

Restore Model 37711

▪

RestoreAdvanced SureScan MRI Model 97713

▪

The amount of time before the battery requires charging is affected by the number of active programs and the stimulation settings in each program (refer to Table 5).

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Table 5. Time until battery requires recharging for Restore and RestoreAdvanced SureScan MRI

1 program

10.5 V

10.0 V

9.0 V

8.0 V

7.0 V

6.0 V

5.0 V

4.0 V

Highest programmed amplitude

3.0 V

2.0 V

1.0 V

Time until battery requires recharging is based on 24-hour per day stimulation using the following settings: rate = 60 Hz, pulse width = 350 μs, impedance = 350 Ω, mode = Cycling off.

3 weeks

1 month

2 program 3 program 4 program

1.5 days2 days3 days6 days

1 week2 weeks

1 week

2 weeks

3 weeks

2 weeks

3 weeks1 month

1 month

1 week

2 weeks

3 weeks

1 month

Battery longevity for the Restore and RestoreAdvanced SureScan MRI Neurostimulators can be evaluated using the following criteria:

EOS (End of service)—9 years after implant, stimulation is not available and an EOS message

▪

appears if you try to interrogate the neurostimulator.

ERI (Elective replacement indicator)—8.5 years after implant, an ERI message is displayed in the

▪

Observations box on the clinician programmer screen.

Time until daily recharging require—Refer to Table 6 for time until daily recharging is required. If the

▪

battery requires daily recharging, a charge daily message appears in the Observations box on the clinician programmer screen. Recharging more than once daily may be inconvenient for the patient to maintain therapy.

If the battery needs daily recharging, you may want to adjust the stimulation settings to increase the time between battery charges or prepare to replace the neurostimulator.

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Table 6. Time until battery requires daily recharging for Restore and RestoreAdvanced SureScan MRI

2 program1 program

10.5 V

10.0 V

9.0 V

8.0 V

7.0 V

6.0 V

5.0 V

4.0 V

Highest programmed amplitude

3.0 V

2.0 V

1.0 V

Time until daily recharging required is based on 24-hour per day stimulation using the following settings: rate = 60 Hz, pulse width = 350 μs, impedance = 350 Ω, mode = Cycling off.

Device will reach EOS before

needing to be fully charged

more than once per day.

3 program

4 program

8 years

PrimeAdvanced, PrimeAdvanced SureScan MRI, RestorePrime, Sequentia LT, and Vanta with AdaptiveStim™ Technology

The battery of an implantable neurostimulator can last for months or years, depending on the following factors:

Programmed parameters (ie, amplitude, rate, pulse width, number of active electrodes used)

▪

System impedance

▪

Hours per day of stimulation

▪

The degree of patient control over programmable stimulation parameters

▪

To optimize the battery longevity of an implantable neurostimulator, follow these tips:

Place the leads in the optimal location to achieve paresthesia.

▪

System Eligibility, Battery Longevity 2021-02-15 English 19

Use fewer programs.

▪

Use the minimum number of electrodes necessary for effective stimulation.

▪

Use the lowest effective settings for amplitude, rate, and pulse width.

▪

Instruct the patient to use the neurostimulator only when needed.

▪

Consider implanting low-impedance leads and extensions.

▪

Estimating battery longevity for Vanta with AdaptiveStim™ Technology or Sequentia LT

The A71200 Vanta/Sequentia LT Clinician Programmer Application and A71300 Stimulation Trialing Clinician Programmer Application each include a battery longevity feature that estimates battery life based on program and group settings, along with the number of hours per day the patient might use each group. Refer to the clinician programmer application manuals for detailed instructions on how to use the battery longevity estimators.

Estimating battery longevity for PrimeAdvanced, PrimeAdvanced SureScan MRI, and RestorePrime

If you choose to implant a PrimeAdvanced Model 37702 Neurostimulator, PrimeAdvanced SureScan MRI Model 97702 Neurostimulator, or RestorePrime Model 37701 Neurostimulator after trial stimulation using the Model 97725 Wireless External Neurostimulator, perform the following steps to estimate battery longevity:

1. Connect the Model 37022 External Neurostimulator and applicable accessories to the lead(s).

2. Adjust the program settings using the clinician programmer to simulate the trial stimulation achieved

with the Model 97725 Wireless External Neurostimulator.

3. Perform battery longevity estimation. Refer to the appropriate battery longevity section below for more information.

The estimation formula provided approximates the period that a battery in a new PrimeAdvanced Model 37702 Neurostimulator, PrimeAdvanced SureScan MRI Model 97702 Neurostimulator, or RestorePrime Model 37701 Neurostimulator will last.

The estimation is based on the settings for one group and on the expected programmed values, the modes of operation, and how often the therapy is used.

Notes:

The use of cycling may cause a reduction in longevity depending on programmed settings. Refer to

▪

steps on estimating battery longevity and the Adjusted Energy Use graph Figure 1 for additional information.

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The estimation formulas include values from reference tables. Ensure the appropriate tables are

▪

referenced based on the type of lead(s) used:

For low-impedance leads (<2 ohms for 10 cm) (eg, 1x8), use Table 7 and Table 8.

–

For standard-impedance leads (eg, Vectris SureScan MRI, Pisces-Quad), use Table 9 and

–

Table 10.

For a mixed pair of leads, use Table 7 and Table 8.

–

Estimating battery longevity

1. Determine the expected programmed values for each program, the expected modes of operation,

and the expected use.

Note: Rates for all programs will be the same.

Expected programmed values

Program 1 Program 2 Program 3 Program 4

Amplitude (V): _____ Amplitude (V): _____ Amplitude (V): _____ Amplitude (V): _____

Rate (Hz): _____ Rate (Hz): _____ Rate (Hz): _____ Rate (Hz): _____

Pulse width (μs): _____ Pulse width (μs): _____ Pulse width (μs): _____ Pulse width (μs): _____

Active

electrodes:

Hours of stimulation per day (including Scheduled

_____ Active

electrodes:

_____ Active

electrodes:

Modes of operation and use

_____

Therapy):

_____ Active

electrodes:

_____

2. Calculate the Program Factor for each program (P1F, P2F, P3F, P4F). a. Locate the Energy Use (EU) for Program 1 (P1EU) from Table 7 or Table 9.

Note: Use the amplitude, rate, and pulse width values entered in Step 1.

P1EU = ______

b. Locate the Electrode Correction Factor (ECF) for Program 1 (P1ECF) from Table 8 or Table 10.

Note: Use the number of active electrodes entered in Step 1.

P1ECF = _____

c. Calculate the Program 1 Factor (P1F):

P1EU _____ × P1ECF _____ = P1F _____

d. For a second program, repeat steps a, b, and c for Program 2.

P2EU = ______ P2ECF = ______

System Eligibility, Battery Longevity 2021-02-15 English 21

P2EU _____ × P2ECF _____ = P2F _____

e. For a third program, repeat a, b, and c for Program 3.

P3EU = ______ P3ECF = ______

P3EU _____ × P3ECF _____ = P3F _____

f. For a fourth program, repeat steps a, b, and c for Program 4.

P4EU = ______ P4ECF = ______

P4EU _____ × P4ECF _____ = P4F _____

3. Calculate the multi-program factor (MPF). Note: Enter 0 for any unused programs.

P1F _____ + P2F _____ + P3F _____ + P4F _____ = MPF _____

4. Calculate the Usage Correction Factor (UCF).

Hours of stimulation per day _____ ÷ 12 hours = UCF _____

5. Calculate the Adjusted Energy Use.

MPF _____ × UCF _____ = Adjusted Energy Use _____

6. Determine the battery longevity from Figure 1 using the Adjusted Energy Use value.

22 English System Eligibility, Battery Longevity 2021-02-15

When calculated adjusted energy use values are at or above 122, cycling at intervals less than 15 seconds on and 15 seconds off may reduce battery longevity.

Longevity Estimate (years)

Cycling is not recommended

for use when calculated adjusted energy

use values are less than 122.

122

5025 90 140 300 500 700 1000 1500 2000

200

Adjusted Energy Use

Figure 1. Longevity estimates for PrimeAdvanced, PrimeAdvanced SureScan MRI, and RestorePrime.

System Eligibility, Battery Longevity 2021-02-15 English 23

Table 7. For low-impedance leads and PrimeAdvanced, PrimeAdvanced SureScan MRI, or RestorePrime

Neurostimulators:

Energy Use

for 2 active electrodes/programsb for 12 hours/day usage

Pulse width (µs)

Amplitude (V) Rate (Hz) 60 210 330 450

30 5 8 11 14

1.0 70 12202633

130 23 37 49 61

30 6 131823

2.0 70 16304356

130 29 57 79 103

30 12 26 38 51

3.0 70 29 62 89 117

130 54 115 163 214

30 18 44 64 82

4.0 70 42 102 148 192

130 78 188 272 353

30 22 54 78 105

5.0 70 51 124 181 243

130 96 231 332 439

30 33 81 117 154

6.0 70 76 186 268 358

130 140 344 493 648

30 41 108 159 219

7.0 70 95 251 384 507

130 174 479 761 979

30 56 143 212 281

8.0 70 127 334 494 649

130 233 616 908 1186

30 66 166 240 355

9.0 70 149 382 625 825

130 275 772 1147 1505

24 English System Eligibility, Battery Longevity 2021-02-15

Table 7. For low-impedance leads and PrimeAdvanced, PrimeAdvanced SureScan MRI, or RestorePrime

Neurostimulators:

Energy Use

for 2 active electrodes/programsb for 12 hours/day usage (continued)

Pulse width (µs)

Amplitude (V) Rate (Hz) 60 210 330 450

30 82 224 337 397

10.0 70 188 527 695 907

130 347 888 1286 1660

Use values that are closest to the expected values (round to the next highest value).

If the number of active electrodes or hours of use is different than these values, adjustments are made in the formula.

Table 8. For low-impedance leads and PrimeAdvanced, PrimeAdvanced SureScan MRI, or RestorePrime

Neurostimulators: Electrode Correction Factor

Number of active negative electrodes

1234567

Number of 1 1.0 1.4 1.5 1.6 1.6 1.6 1.7

active 2 1.4 1.9 2.2 2.3 2.4 2.5 --

positive 3 1.5 2.2 2.5 2.8 2.9 -- --

electrodes 4 1.6 2.3 2.8 3.1 -- -- --

5 1.62.42.9--------

6 1.6 2.5 -- -- -- -- --

7 1.7------------

Table 9. For standard-impedance leads and PrimeAdvanced, PrimeAdvanced SureScan MRI, or RestorePrime

Neurostimulators: Energy Use

for 2 active electrodes/programsb for 12 hours/day usage

Pulse width (µs)

Amplitude (V) Rate (Hz) 60 210 330 450

30 5 7 9 11

1.0 70 11172227

130 21 32 41 50

30 5 101418

2.0 70 13253443

130 25 47 64 80

30 10 21 30 38

3.0 70 24507090

130 45 92 129 164

30 15 35 50 65

4.0 70 36 82 117 151

System Eligibility, Battery Longevity 2021-02-15 English 25

Table 9. For standard-impedance leads and PrimeAdvanced, PrimeAdvanced SureScan MRI, or RestorePrime

Neurostimulators: Energy Use

for 2 active electrodes/programsb for 12 hours/day usage (continued)

Pulse width (µs)

Amplitude (V) Rate (Hz) 60 210 330 450

130 67 151 214 276

30 17 42 61 79

5.0 70 41 98 142 185

130 76 180 260 336

30 26 62 91 118

6.0 70 60 144 210 273

130 110 266 384 499

30 34 86 125 165

7.0 70 79 197 289 378

130 145 362 529 688

30 46 115 167 219

8.0 70 105 263 386 503

130 194 483 704 918

30 50 126 184 243

9.0 70 114 292 428 561

130 209 534 885 1158

30 67 157 231 307

10.0 70 135 359 534 703

130 248 660 976 1278

Use values that are closest to the expected values (round to the next highest value).

If the number of active electrodes or hours of use is different than these values, adjustments are made in the formula.

Table 10. For standard-impedance leads and PrimeAdvanced, PrimeAdvanced SureScan MRI, or

RestorePrime Neurostimulators: Electrode Correction Factor

Number of active negative electrodes

1234567

Number of 1 1.0 1.5 1.6 1.7 1.7 1.8 1.8

active 2 1.5 2.0 2.3 2.5 2.6 2.7 --

positive 3 1.6 2.3 2.8 3.0 3.2 -- --

electrodes 4 1.7 2.5 3.0 3.4 -- -- --

5 1.72.63.2--------

26 English System Eligibility, Battery Longevity 2021-02-15

Table 10. For standard-impedance leads and PrimeAdvanced, PrimeAdvanced SureScan MRI, or

RestorePrime Neurostimulators: Electrode Correction Factor (continued)

Number of active negative electrodes

1234567

6 1.8 2.7 -- -- -- -- --

7 1.8------------

Itrel 4

Estimating battery longevity for Itrel 4

If you choose to implant an Itrel 4 Model 37703 or Model 37704 Neurostimulator after trial stimulation using the Model 97725 Wireless External Neurostimulator, perform the following steps to estimate battery longevity:

1. Connect the Model 37021 External Neurostimulator and applicable accessories to the lead(s).

2. Adjust the program settings using the clinician programmer to simulate the trial stimulation achieved

with the Model 97725 Wireless External Neurostimulator.

3. Perform battery longevity estimation. Refer to the battery longevity section below for more information.

The estimation formula provided approximates the period that a new Itrel 4 Model 37703 or Model 37704 neurostimulator battery will last. The estimation is based on the expected programmed values, the modes of operation, and how often the therapy is used.

Notes:

The use of cycling may cause a reduction in longevity depending on programmed settings. Refer to

▪

Figure 2 for additional information.

The estimation formulas include values from reference tables. Ensure the appropriate tables are

▪

referenced based on the type of lead(s) used:

For low-impedance leads (<2 ohms for 10 cm) (eg, Pisces Z Quad), use Table 11 and Table 12.

–

For standard-impedance leads (eg, Vectris SureScan MRI, Pisces-Quad), use Table 13 and

–

Table 14.

Estimating battery longevity

1. Determine the expected programmed values, the expected modes of operation, and the expected

use.

System Eligibility, Battery Longevity 2021-02-15 English 27

Expected programmed values

Amplitude (V): _____

Rate (Hz): _____

Pulse width (μs): _____

Active electrodes: _____

Modes of operation and use

Hours of stimulation per day: _____

If estimating battery longevity when using the Cycling feature,

contact your Medtronic representative for assistance.

2. Locate the Energy Use (EU) from Table 11 or Table 13. Note: Use the amplitude, rate, and pulse width values entered in Step 1.

EU = ______

3. Locate the Electrode Correction Factor (ECF) from Table 12 or Table 14. Note: Use the number of active electrodes entered in Step 1.

ECF = _____.

4. Calculate the Usage Correction Factor (UCF).

Hours of stimulation per day _____ ÷ 12 hours = Usage Correction Factor_____

5. Calculate the Adjusted Energy Use:

EU _____ × ECF _____ × UCF _____ + [12.2 × (2 - UCF _____)] = Adjusted Energy Use _____

6. Determine the battery longevity from Figure 2 using the Adjusted Energy Use value.

28 English System Eligibility, Battery Longevity 2021-02-15

Longevity Estimate (years)

Cycling is not recommended for use when calculated adjusted energy use values are less than 118.

When calculated adjusted energy use values are at or above 118, cycling at intervals less than 15 seconds on and 15 seconds off may reduce battery longevity.

118

5025 90 140 300 500 700 1000 1500 2000

200

Adjusted Energy Use

Figure 2. Itrel 4 Neurostimulator

longevity estimates (years) for energy use.

Table 11. For low-impedance leads and Itrel 4 Neurostimulators: Energy Use

12 hours/day usage

Pulse width (µs)

Amplitude (V) Rate (Hz) 60 210 330 450

30 3 6 9 11

1.0 70 7 15 21 27

130 12 27 38 49

for 2 active electrodesb for

30 4 111621

2.0 70 10253749

130 18 47 68 89

30 9 243546

3.0 70 21 55 81 106

System Eligibility, Battery Longevity 2021-02-15 English 29

Table 11. For low-impedance leads and Itrel 4 Neurostimulators: Energy Use

for 2 active electrodesb for

12 hours/day usage (continued)

Pulse width (µs)

Amplitude (V) Rate (Hz) 60 210 330 450

130 38 101 148 194

30 14 39 60 80

4.0 70 33 92 139 185

130 60 171 256 337

30 20 54 81 107

5.0 70 44 126 188 248

130 82 231 344 453

30 27 75 112 148

6.0 70 61 173 259 343

130 113 318 476 662

30 37 104 156 206

7.0 70 83 239 360 476

130 152 440 659 869

30 50 140 209 276

8.0 70 113 321 482 637

130 207 590 882 1161

30 59 169 254 337

9.0 70 132 388 595 809

130 242 728 1116 1475

30 70 203 318 423

10.0 70 158 487 737 978

130 289 897 1394 1912

Use values that are closest to the expected values (round to the next highest value).

If the number of active electrodes or hours of use is different than these values, adjustments are made in the formula.

Table 12. For low-impedance leads and Itrel 4 Neurostimulators: Electrode Correction Factor (ECF)

Number of active negative electrodes

Number of active positive

1234

electrodes

Case 1.6 2.7 3.5 4.1

30 English System Eligibility, Battery Longevity 2021-02-15

Table 12. For low-impedance leads and Itrel 4 Neurostimulators: Electrode Correction Factor (ECF) (continued)

Number of active negative electrodes

Number of active positive

1234

electrodes

1 1.0 1.3 1.5 --

2 1.3 2.0 -- --

3 1.5------

Table 13. For standard-impedance leads and Itrel 4 Neurostimulators: Energy Use

for 2 active electrodesb for

12 hours/day usage

Pulse width (µs)

Amplitude (V) Rate (Hz) 60 210 330 450

30 2579

1.0 70 6 12 17 22

130 11 22 31 40

30 3 9 13 16

2.0 70 8 20 29 38

130 15 37 54 70

30 8 192736

3.0 70 17436383

130 32 79 116 151

30 11 29 43 57

4.0 70 26 67 100 135

130 47 123 185 250

30 15 40 60 81

5.0 70 33 93 143 191

130 62 175 265 349

30 22 59 87 115

6.0 70 50 135 201 265

130 92 247 366 481

30 30 81 121 160

7.0 70 67 186 278 367

130 123 340 506 666

30 38 104 159 213

System Eligibility, Battery Longevity 2021-02-15 English 31

Table 13. For standard-impedance leads and Itrel 4 Neurostimulators: Energy Use

Amplitude (V) Rate (Hz) 60 210 330 450

8.0 70 86 246 372 491

130 158 457 678 891

30 47 131 196 260

9.0 70 105 300 451 597

130 193 550 824 1128

30 57 158 236 314

10.0 70 127 361 551 751

130 231 672 1034 1362

Use values that are closest to the expected values (round to the next highest value).

If the number of active electrodes or hours of use is different than these values, adjustments are made in the formula.

12 hours/day usage (continued)

Pulse width (µs)

for 2 active electrodesb for

Table 14. For standard-impedance leads and Itrel 4 Neurostimulators: Electrode Correction Factor (ECF)

Number of active positive

electrodes

Case 1.7 2.9 3.9 4.6

1 1.0 1.3 1.5 --

2 1.3 2.0 -- --

3 1.5------

Number of active negative electrodes

1234

Estimating battery longevity examples

Example 1: PrimeAdvanced, PrimeAdvanced SureScan MRI, or RestorePrime Neurostimulator and 4 programs with low-impedance leads

1. Based on the patient's medical condition, the expected programmed values and modes of operation

are as follows:

Expected programmed values

Program 1 Program 2 Program 3 Program 4

Amplitude: 3.0 V Amplitude: 5.0 V Amplitude: 5.0 V Amplitude: 5.0 V

32 English System Eligibility, Battery Longevity 2021-02-15

Expected programmed values

Program 1 Program 2 Program 3 Program 4

Rate: 30 Hz Rate: 30 Hz Rate: 30 Hz Rate: 30 Hz

Pulse width: 330 μs Pulse width: 210 μs Pulse width: 210 μs Pulse width: 210 μs

Active

electrodes:

Hours of stimulation per day (including Scheduled

0+, 6−, remaining Off

Active

electrodes:

3−, 4−, 5+, remaining Off

Modes of operation and use

Therapy):

Active

electrodes:

7−, 8−, 9+, remaining Off

Active

electrodes:

10−, 11−, 12+, remaining Off

2. Program Factors for each program (P1F, P2F, P3F, P4F): a. Energy Use for Program 1 from Table 7:

P1EU = 38

b. Electrode Correction Factor for Program 1 from Table 8:

P1ECF = 1.0

c. Program 1 Factor:

P1EU × P1ECF = P1F

38 × 1.0 = 38

d. Program 2 Factor:

P2EU × P2ECF = P2F

54 × 1.4 = 75.6

e. Program 3 Factor:

P3EU × P3ECF = P3F

54 × 1.4 = 75.6

f. Program 4 Factor:

P4EU × P4ECF = P4F

54 × 1.4 = 75.6

3. Multi-Program Factor (MPF):

P1F + P2F + P3F + P4F = MPF

38 + 75.6 + 75.6 + 75.6 = 264.8

4. Usage Correction Factor (UCF):

a. UCF = hours of stimulation ÷ 12 hours

12 ÷ 12 = 1.0

5. Adjusted Energy Use:

MPF × UCF = Adjusted Energy Use

264.8 × 1.0 = 264.8

6. The battery longevity from Figure 1 = approximately 2.5 years.

System Eligibility, Battery Longevity 2021-02-15 English 33

Example 2: Itrel 4 Neurostimulator with standardimpedance lead

1. Based on the patient's medical condition, the expected programmed values and modes of operation

are as follows:

Expected programmed values

Amplitude (V): 4.2

Rate (Hz): 30

Pulse width (μs): 450

Active electrodes: Case+, 2−, remaining Off

Modes of operation and use

Hours of stimulation per day: 18

2. Energy Use from standard-impedance Table 13: EU = 57

3. Electrode Correction Factor (ECF) from standard-impedance Table 14: ECF = 1.7

4. Usage Correction Factor (UCF): a. UCF = Hours of stimulation ÷ 12 hours

18 ÷ 12 = 1.5

5. Adjusted Energy Use:

Adjusted Energy Use = EU × ECF × UCF + [12.2 × (2-UCF)]

57 × 1.7 × 1.5 + [12.2 × (2-1.5)] = 57 × 1.7 × 1.5 + 6.1 = 151.5

6. The battery longevity from Figure 2 = approximately 2.8 years.

34 English System Eligibility, Battery Longevity 2021-02-15

System Eligibility, Battery Longevity 2021-02-15 English 35

Manufacturer

Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com Tel. +1-763-505-5000

REP

Authorized Representative in the European Community

Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel. +31-45-566-8000

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

Asia-Pacific

Medtronic International Ltd. 50 Pasir Panjang Road #04-51 Mapletree Business City Singapore 117384 Singapore Tel. +65-6870-5510

*MA00152A189*

2021-02-15 MA00152A189 Rev A

Medtronic A710 Reference Guide

Specifications and Main Features

Frequently Asked Questions

User Manual

Explanation of symbols on product and package labeling.

Table of contents

System eligibility

Trial stimulation devices

Trial stimulation for Itrel 4 using the Model 97725 Wireless External Neurostimulator

Trial stimulation for Itrel 4 using the Model 37022 External Neurostimulator

Battery longevity and maintenance

Intellis and Intellis with AdaptiveStim™ Technology

RestoreSensor, RestoreSensor SureScan MRI, and RestoreUltra SureScan MRI

Restore and RestoreAdvanced SureScan MRI

Estimating battery longevity for Vanta with AdaptiveStim™ Technology or Sequentia LT

Estimating battery longevity for PrimeAdvanced, PrimeAdvanced SureScan MRI, and RestorePrime

Itrel 4

Estimating battery longevity for Itrel 4

Estimating battery longevity examples