Medtronic 97714 User Manual

RestoreSensor® SureScan® MRI

Rechargeable neurostimulator

Implant manual

  Rx only

97714

2013

Explanation of symbols on product or package labeling

Refer to the appropriate product for symbols that apply.

Open here

Do not use if package is damaged

Do not reuse

Do not resterilize

2

STERILIZE

Sterilized using ethylene oxide

-XX °C

-XX °F

EC

EO

Consult instructions for use

Date of manufacture

Manufacturer

Use by

XX °C

Temperature limitation

XXX °F

Serial number

Conformité Européenne (European Conformity). This symbol means
that the device fully complies with AIMD Directive 90/385/EEC (NB

0123).

Authorized Representative in the European Community

REP

STERILE

For USA audiences only

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Medtronic®, AdaptiveStim®, RestoreSensor®, SoftStart/Stop®, and SureScan® are
trademarks of Medtronic, Inc., registered in the U.S. and other countries.

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Table of contents

Description 7

Neurostimulation systems with SureScan MRI Technology 7

Package contents 7

Patient identification card 7

Device specifications 7

Declaration of conformity 11

Implanted components and MRI scans 12

Implant criteria for full-body MRI scan eligibility 12
When changing components 12
When explanting components 13

Instructions for use 13

Charging the neurostimulator battery 13
Verifying neurostimulator operation 14
Connecting the extension or lead to the neurostimulator 14
Implanting the neurostimulator 16

Refer to the indications sheet for indications and related information.

Refer to the appropriate information for prescribers booklet for contraindications,
warnings, precautions, adverse events summary, individualization of treatment,
patient selection, use in specific populations, resterilization, and component
disposal.

Refer to the MRI Guidelines for Medtronic Neurostimulation Systems for Chronic
Pain instructions for use manual for the MRI conditions and MRI-specific warnings
and precautions for conducting an MRI scan.

Refer to the System Eligibility, Battery Longevity, Specifications reference manual
for neurostimulator selection, battery longevity calculations and specific
neurostimulator specifications.

Refer to the clinical summary booklet for information on the clinical study

results of the neurostimulation system and individualization of treatment.

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Checking system integrity 18
Completing the implant procedure 18

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Description

The Medtronic RestoreSensor SureScan MRI Model 97714 Neurostimulator is part of a
neurostimulation system for pain therapy.

Neurostimulation systems with SureScan MRI Technology

When a Medtronic neurostimulation system with SureScan MRI Technology is implanted as
directed (see "Implant criteria for full-body MRI scan eligibility" on page 12), a patient's full
body may be eligible for MRI scans under specific conditions, ie, any part of the patient's
anatomy can be scanned when specific conditions are met.

For the MRI conditions and MRI-specific warnings and precautions for conducting an MRI
scan, refer to the MRI guidelines for Medtronic neurostimulation systems for chronic pain
instructions for use manual.

Package contents

Neurostimulator

▪

Torque wrench

▪

Product literature

▪

Warranty card

▪

Registration form

▪

Patient identification card

▪

Patient identification card

A patient identification card is packaged with this device. Advise the patient to carry the
most up-to-date identification card at all times and to bring the card to all MRI
appointments.

The patient identification card packaged with the device is temporary; a permanent

card will be mailed to the patient when Medtronic receives the registration form.
The implant registration form registers the device warranties and creates a record of the

device in Medtronic’s implant data system.

Device specifications

The neurostimulator is a multi-programmable, rechargeable device that delivers stimulation
through 1 or more leads. The stimulation settings are stored in programs. A program is a
specific combination of pulse width, rate, and amplitude settings acting on a specific
electrode combination (up to 16 electrodes per program). Up to 4 programs can be
combined into a group. When using more than 1 program, the pulses are delivered
sequentially—first a pulse from one program, then a pulse from the next program.

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Pulse width, amplitude, and electrode polarity for each program within the group can have
different values. Rate, rate limits, ramping, and cycling for each program within the group
have the same values.

Table 1. Operating values for the RestoreSensor SureScan MRI Model 97714

Programmable parameter

Number of defined groups

Number of programs per
group

Operating range and resolution

1 to 8

1 to 4

neurostimulator

a

b

b

Electrode configuration 2 to 16 electrodes as anode (+), cathode (-), or Off
Amplitude 0 to 10.5 V with 0.05-V or 0.1-V resolution
Amplitude – upper patient

limit

Amplitude – lower patient
limit

Tracking limit: programmed value +0 to +4 V (0.5-V
resolution)

Custom limit: programmed value up to 10.5 V (same
resolution as amplitude)

Custom limit: 0 V to the programmed value (same resolution

as amplitude)
Pulse width 60 to 1000 µs (10-µs resolution)
Pulse width – upper patient

c

limit

Pulse width – lower patient

c

limit
Rate 2 to 1200 Hz (resolution: 1 Hz from 2 Hz to 10 Hz; 5 Hz from

Tracking limit: programmed value +0 to +300 µs (60-µs

resolution)

Custom limit: programmed value up to 1000 µs (10-µs

resolution)

Custom limit: 60 µs to the programmed value (10-µs

resolution)

10 Hz to 250 Hz; 10 Hz from 250 Hz to 500 Hz; 20 Hz from

500 Hz to 1000 Hz; 50 Hz from 1000 Hz to 1200 Hz)

d

Rate – upper patient limit Tracking limit: programmed value +0, +10, +20, +50, +100 Hz

Custom limit: programmed value to 1200 Hz (same resolution

as rate)
Rate – lower patient limit Custom limit: 2 to the programmed value (same resolution as

rate)
SoftStart/Stop Off, On: 1, 2, 4, or 8 second ramp duration

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Table 1. Operating values for the RestoreSensor SureScan MRI Model 97714

Programmable parameter

Cycling Off, On: 0.1 s to 30 min (resolution: 0.1 s from 0.1 s to 1 s; 1 s

neurostimulator (continued)

Operating range and resolution

from 1 s to 1 min; 1 min from 1 min to 30 min)

a

AdaptiveStim Off, On: 6 positions

a

Interlocks will prevent the use of some parameter combinations.

b

No more than 16 programs may be defined within the 8 groups.

c

Pulse width limit and rate limit are not available for groups with AdaptiveStim enabled.

d

Rate limited to 600 Hz when 2 programs per group are active, 400 Hz when 3 programs per group are
active, and 300 Hz when 4 programs per group are active.

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Table 2. Physical characteristics of the RestoreSensor SureScan MRI Model 97714

neurostimulator

a

Description Value

Connector type Octapolar, in-line 2.8-mm (0.110-in) spacing
Height 54.0 mm (2.1 in)
Length 54.0 mm (2.1 in)
Thickness

case 9.0 mm (0.4 in)

connector 11.0 mm (0.4 in)
Weight 45.0 g (1.6 oz)
Volume

22.0 cm

3

(1.34 in3)

Battery life 9 years
Power source Lithium ion rechargeable battery
Temperature limitation –18 °C to +52 °C (0 °F to +126 °F)

Serial number model designator

b

Radiopaque identification (ID) code

a

All measurements are approximate.

b

The serial number is the model designator followed by a number. The clinician programmer displays the
entire serial number beginning with the model designator.

c

The radiopaque ID code is located in the connector block; NMA indicates that the neurostimulator has
SureScan MRI Technology. This radiopaque ID code is for confirming, if needed, that a SureScan MRI
neurostimulator is implanted and is not to be used for concluding that the entire neurostimulation system
is full-body MRI scan eligible.

NMD

c

NMA

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Table 3. Material of components in the RestoreSensor SureScan MRI Model 97714

Components Material Material contacts

Neurostimulator

Case Titanium Yes
Connector block Polysulfone, silicone rubber,

Grommets, seals Silicone rubber Yes
Setscrews Titanium alloy Yes
Adhesive Silicone medical adhesive Yes

Torque wrench

Handle Polyetherimide Yes
Shaft Stainless steel Yes

silicone medical adhesive

package

human tissue

Yes

Declaration of conformity

Medtronic declares that this product is in conformity with the essential requirements of

Directive 90/385/EEC on Active Implantable Medical Devices.

For additional information, contact the appropriate Medtronic representative listed on the

inside back cover of this manual.

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Implanted components and MRI scans

Implant criteria for full-body MRI scan eligibility

Caution: To allow a patient full-body MRI scan eligibility under specific conditions,

implant a Medtronic neurostimulation system with SureScan MRI Technology as
follows:

Use only SureScan MRI neurostimulation system components (eg, leads and

▪

neurostimulators).
Note: Extension model numbers in the 3708 series (eg, 37081, 37082, 37083) are

not full-body MRI scan eligible.
Implant the neurostimulator in the buttocks, abdomen, or flank (ie, the lateral and

▪

posterior region between the ribs and pelvis).
Place the lead tip(s) in the spinal epidural space.

▪

Explant any previously abandoned pain leads or extensions that may be in the

▪

patient (ie, leads or extensions, or portions of, that are not connected to a
neurostimulator).

Note: Confirm MRI compatibility of any other implanted medical devices. Other
implanted medical devices may limit or restrict MRI scans.

Enter all component model number and implant location information using the

▪

clinician programmer.

If the above implant criteria are not met, the patient will not have a neurostimulation
system with full-body MRI scan eligibility. MRI scan eligibility will be restricted.

For the MRI conditions and MRI-specific warnings and precautions for conducting an
MRI scan, refer to the MRI guidelines for Medtronic neurostimulation systems for
chronic pain instructions for use manual.

When changing components

Warning: Before explanting and replacing an existing neurostimulator, print a report

from the existing neurostimulator that shows implanted and any abandoned
component information. When adding, changing, or removing neurostimulators, leads,
extensions, and accessories, always program up-to-date component model numbers,
implant locations, and any abandoned component information to re-establish MRI­scan eligibility.

If this information is not updated or is entered incorrectly, MRI scan-type eligibility data
will be inaccurate, and the patient is at risk for one of the following:

The patient is allowed to have an MRI scan inappropriate for the implanted

▪

components, which could cause tissue heating, resulting in tissue damage or
serious patient injury.

The patient is unnecessarily restricted from having an MRI scan.

▪

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When explanting components

Caution: If permanently explanting a neurostimulator, be sure to also explant all

leads, extensions, and accessories. Abandoned components may prevent the patient
from being allowed MRI scans in the future due to concerns of lead electrode heating
that can result in tissue damage.

Instructions for use

Implanting physicians should be experienced in epidural-access procedures and should be

thoroughly familiar with all product labeling.

Warning: DO NOT use the recharger on an unhealed wound. The recharging system
is not sterile, and contact with the wound can cause an infection.

Caution: Advise patients to charge the neurostimulator when a Low battery ( )
screen is displayed on the patient programmer or recharger; this prevents the battery
from overdischarging. If the neurostimulator battery is allowed to overdischarge, the
patient cannot charge the neurostimulator; however, the clinician may be able to
restore the battery function using the Physician Recharge Mode on the recharger
(refer to the troubleshooting section of the software manual).

Allowing the neurostimulator battery to overdischarge will permanently affect the
neurostimulator in one of the following ways:

Battery function is restored; however, charging sessions may be more frequent

▪

because battery capacity has been reduced.
Battery function is not restored and the neurostimulator must be surgically

▪

replaced. Battery function is not restored when:

the neurostimulator battery is permanently damaged.

–

the neurostimulator battery has been overdischarged and restored twice

–

before. The third time the battery is overdischarged, the neurostimulator will
reach end of service. Surgery is required to replace the neurostimulator.

Cautions:

When using sharp instruments near the neurostimulator, be extremely careful to

▪

avoid nicking or damaging the case, the insulation, or the connector block.
Damaging the neurostimulator may require surgical replacement.

Do not use saline or other ionic fluids at connections, which could result in a short

▪

circuit.

Charging the neurostimulator battery

Charge the neurostimulator battery before opening the package. For charging instructions,

refer to the charging system user manual.

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Verifying neurostimulator operation

Before opening the sterile neurostimulator package, verify that the neurostimulator is
operable by using the clinician programmer to interrogate the neurostimulator and read the
neurostimulator battery charge level. (Refer to the software manual for instructions on how
to read the battery charge level.)

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.

Note: The neurostimulator pocket may be flushed with an antibiotic solution; do not
submerge the neurostimulator in fluid.

Connecting the extension or lead to the 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 or lead connector pins with sterile gauze. If necessary, use sterile
(United States Pharmacopeia [USP]) water or a nonionic antibiotic solution.

2. Make sure the connector block receptacles are dry and clean.

3. Insert the appropriate extension or lead connector pins into the appropriate

neurostimulator socket until they are seated fully within the connector block (Figure 1).

Notes:

During insertion, some resistance is typical.

▪

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.

Caution: Do not insert the extension or lead connector into the connector block
if the setscrews are not sufficiently retracted. Unretracted setscrews may
damage the extension or lead and prevent the extension or lead from fully
seating into the connector block.

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Socket II (Electrodes 8-15)

Socket I (Electrodes 0-7)

Extension
or Lead 1

Extension

or Lead 2

Figure 1. Insert the extension or lead connector pins fully into the neurostimulator.

Note:

Insert a connector plug (from an accessory kit) into any unused neurostimulator

socket.

4.

For each extension, lead, or plug, fully insert the torque wrench into each self-sealing
grommet of the connector block and tighten each setscrew (Figure 2).

Cautions:

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.

Before tightening setscrews, ensure that the extension or lead connector

▪

pins are inserted into the connector block to prevent damaging the lead or
extension.

Verify that each leaf of 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.

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Figure 2. Tightening the setscrews in the self-sealing grommet.

Implanting the neurostimulator

Warning

: Do not enclose a neurostimulator with SureScan MRI Technology in a
cover, such as those used to mitigate a titanium allergy. A neurostimulator cover may
cause significant heating of the lead electrodes during an MRI scan, placing the
patient at risk for tissue heating, resulting in tissue damage or serious patient injury.

Warning

: Do not tie ligatures directly around the lead body. Ligatures around the lead
body can damage the lead body or conductor wires, resulting in a loss of therapy.
During an MRI scan, the patient could be at risk of tissue heating, resulting in tissue
damage or serious patient injury.

Caution

: To prevent device inversion, do not make the neurostimulator pocket any
larger than necessary to fit the neurostimulator and excess lead or extension. Device
inversion may result in component damage, lead dislodgement, skin erosion, or
stimulation at the implant site, requiring repeat surgery to restore therapy.

Note:

For full-body MRI scan eligibility, confirm that the subcutaneous pocket for the

neurostimulator has been created in the buttocks, abdomen, or flank. (See the caution in
"Implant criteria for full-body MRI scan eligibility" on page 12.)

1.

With the Medtronic logo facing outward, away from muscle tissue, rotate the
neurostimulator counterclockwise to coil the excess lead or extension (Figure 3).

Caution

: Do not twist or kink the lead or extension bodies when rotating the
neurostimulator and coiling the excess lead or extension. Twisting or kinking of
the components creates a torsional load that may increase the risk of unwanted
movement or damage to the neurostimulation system components.

16 English  97714 2016-06-01

Figure 3. Rotate counterclockwise to coil excess lead or extension length.

Insert the neurostimulator and excess lead or extension coils into the subcutaneous

2.

pocket with the Medtronic logo facing outward, away from muscle tissue. Ensure that
the leads or extensions are not twisted or bent sharply.

Cautions:

Ensure that the neurostimulator is placed no deeper than 1 cm (0.4 in)

▪

below the skin and is parallel to the skin. If the neurostimulator is too deep
or is not parallel to the skin, recharge may be inefficient or unsuccessful.

Position the neurostimulator with the Medtronic logo facing outward. If

▪

implanted with the Medtronic logo facing inward, the neurostimulator will be
difficult to charge.

Do not coil excess extensions or leads in front of the neurostimulator. Wrap

▪

excess extensions or leads around the perimeter (Figure 4) or behind the
neurostimulator to help minimize potential damage during neurostimulator
replacement surgery, help minimize potential kinking of the extension or
lead, and minimize interference with telemetry and recharge operation.

Figure 4. Wrap excess extensions or leads around the perimeter (or behind)

the neurostimulator.

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3.

Use the suture holes in the connector block to secure the neurostimulator to the
muscle fascia with nonabsorbable silk.

Notes:

Secure the neurostimulator in the pocket to minimize movement or migration of the

▪

neurostimulator.
Suturing the neurostimulator also may prevent movement of the neurostimulator

▪

from torque and other forces during an MRI scan.

Checking system integrity

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 for integrity

to ensure proper readings.

1.

To ensure proper connection of each extension or lead to the neurostimulator, use the
clinician programmer to program the basic stimulation parameters, check the battery
status, and check the electrode impedances to rule out a short or open circuit.

2.

If the system integrity test results are not acceptable, refer to "Connecting the
extension or lead to the neurostimulator" on page 14.

3.

Complete the stimulation assessment form.

Completing the implant procedure

1.

Close and dress all incisions.

2.

Ensure that a patient control device and a completed patient identification card are
given to the patient.

3.

Complete the device tracking and patient registration paperwork and return the
documents to Medtronic.

18 English  97714 2016-06-01

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Contacts:

Asia:

Medtronic International Ltd.
Tel. [phone]
Fax [phone]

Medtronic Asia Ltd.
Tel. [phone]

Fax [phone]

Australia:

Medtronic Australasia Pty. Ltd.
97 Waterloo Road
North Ryde, NSW 2113
Australia
Tel. [phone]
Fax [phone]
Toll-free 1-800-668-670

Austria:

Medtronic Österreich GmbH
Tel. [phone]
Fax [phone]

Belgium:

Medtronic Belgium S.A.
Tel. [phone]
Fax [phone]

Canada:

Medtronic of Canada Ltd.
Tel. [phone]
Fax (1905)-826-6620

Czech Republic:

Medtronic Czechia s.r.o.
Tel. [phone]
Fax [phone]

Denmark:

Medtronic Danmark A/S
Tel. [phone]
Fax [phone]

Finland:

Medtronic Finland Oy/LTD
Tel. [phone]
Fax [phone]

France:

Medtronic France S.A.S.
Tel. [phone]
Fax [phone]

Germany:

Medtronic GmbH
Tel. [phone]
Fax [phone]

Greece:

Medtronic Hellas S.A.
Tel. [phone]
Fax [phone]

Hungary:

Medtronic Hungária Kft.
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Fax [phone]

Ireland:

Medtronic Ireland Ltd.
Tel. [phone]
Fax [phone]

Italy:

Medtronic Italia SpA
Tel. [phone]
Fax [phone]

Tel. [phone]
Fax [phone]

Japan:

Medtronic Japan
Tel. [phone]
Fax [phone]

Latin America:

Medtronic, Inc.
Tel. [phone]
Fax [phone]

Norway:

Medtronic Norge AS
Tel. [phone]
Fax [phone]

Poland:

Medtronic Poland Sp. z.o.o.
Tel. [phone]
Fax [phone]

Portugal:

Medtronic Portugal, Lda.
Tel. [phone]
Fax [phone]

Russia:

Medtronic Russia
Tel. [phone]
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Slovakia:

Medtronic Slovakia, o.z.
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Spain:

Medtronic Ibérica, S.A.
Tel. [phone]
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Sweden:

Medtronic AB
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Switzerland:

Medtronic (Schweiz) AG
Tel. [phone]
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The Netherlands:

Medtronic B.V.
Tel. [phone]
Fax [phone]

Turkey:

Medtronic Turkey
Tel. [phone]
Fax [phone]

U.K.:

Medtronic U.K. Ltd.
Tel. [phone]
Fax [phone]

USA:

Medtronic, Inc.
Tel. [phone]
Fax [phone]
Toll-free: (1-800)-328-0810

Manufacturer

Medtronic, Inc.
710 Medtronic Parkway,
Minneapolis, MN 55432-5604,
USA
www.medtronic.com
Tel. [phone]
Fax [phone]

REP

Authorized Representative
in the European Community

Medtronic B.V.
Earl Bakkenstraat 10,
6422 PJ Heerlen,
The Netherlands
Tel. [phone]
Fax [phone]

Europe/Africa/Middle East Headquarters

Medtronic International Trading Sàrl
Route du Molliau 31,
Case Postale 84
CH - 1131 Tolochenaz,
Switzerland
www.medtronic.eu
Tel. [phone]
Fax [phone]

Asia-Pacific

Medtronic International Ltd.
Suite 1106-11, 11/F, Tower 1, The Gateway,
25 Canton Road, Tsimshatsui,
Kowloon,
Hong Kong
Tel. [phone]
Fax [phone]

Contacts for specific countries are listed inside this cover.

EC

*M940100A007*

© Medtronic, Inc. 2016
All Rights Reserved

M940100A007 Rev A