Medtronic 97713 User Manual

RestoreAdvanced® SureScan® MRI

Rechargeable neurostimulator

Implant manual

  Rx only

97713

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

97713 2016-06-01  English 3

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

®

4 English  97713 2016-06-01

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 10

Implanted components and MRI scans 11

Implant criteria for full-body MRI scan eligibility 11
When changing components 11
When explanting components 12

Instructions for use 12

Charging the neurostimulator battery 12
Verifying neurostimulator operation 12
Connecting the extension or lead to the neurostimulator 13
Implanting the neurostimulator 15

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.

97713 2016-06-01  English 5

Checking system integrity 17
Completing the implant procedure 17

6 English  97713 2016-06-01

Description

The Medtronic RestoreAdvanced SureScan MRI Model 97713 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 11), 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 four programs can be
combined into a MyStim group. When using more than one program, the pulses are
delivered sequentially—first a pulse from one program, then a pulse from the next program.

97713 2016-06-01  English 7

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 RestoreAdvanced SureScan MRI Model 97713

neurostimulator

a

Programmable parameter Operating range and resolution

Number of defined MyStim groups

Number of programs per MyStim group

Electrode configuration 2 to 16 electrodes as anode (+), cathode (-), or

Amplitude

Amplitude – upper patient limit Tracking limit: programmed value +0 to +4 V (0.5

Amplitude – lower patient limit Custom limit: 0 V to the programmed value (same

b

1 to 26

b

1 to 4

Off

0 to 10.5 V with 0.05 V or 0.1 V resolution

c

V resolution)
Custom limit: programmed value up to 10.5 V

(same resolution as amplitude)

resolution as amplitude)
Pulse width 60 to 450 µs (10 µs resolution)
Pulse width – upper patient limit Tracking limit: programmed value +0 to +150 µs

(30 µs resolution)

Custom limit: programmed value up to 450 µs

(10 µs resolution)
Pulse width – lower patient limit Custom limit: 60 µs to the programmed value

Rate 2 to 130 Hz (1 Hz resolution to 10 Hz; 5 Hz

Rate – upper patient limit Tracking limit: programmed value +0 to +50 Hz

Rate – lower patient limit Custom limit: 2 Hz to the programmed value (1 Hz

(10 µs resolution)

resolution from 10 Hz to 130 Hz)

(10 Hz resolution)

resolution to 10 Hz; 5 Hz resolution from 10 Hz to

d

130 Hz)

d

SoftStart/Stop Off, On: 1, 2, 4, or 8 sec ramp duration
Cycling Off, On: 0.1 sec to 30 min (resolution: 0.1 sec

from 0.1 sec to 1 sec; 1 sec from 1 sec to 1 min;

1 min from 1 min to 30 min)

8 English  97713 2016-06-01

Table 1. Operating values for the RestoreAdvanced SureScan MRI Model 97713

neurostimulator

a

(continued)

Programmable parameter Operating range and resolution

Scheduled therapy Off, On: 1 to 8 events per 24 h period
GroupAdjust Off, On

a

All values are approximate.

b

No more than 32 programs may be defined within the 26 MyStim groups.

c

Only 0.1 V resolution possible from 10.0 V to 10.5 V amplitude.

d

Rate limited to 85 Hz when 3 programs/group are active and to 65 Hz when 4 programs/group are active.

Table 2. Physical characteristics of the RestoreAdvanced SureScan MRI Model 97713

neurostimulator

a

Description Value

Connector type Octapolar, in-line 2.8 mm (0.110 in) spacing
Height 65.0 mm (2.6 in)
Length 49.0 mm (1.9 in)
Thickness

case 15.0 mm (0.6 in)

connector 15.0 mm (0.6 in)
Weight 72.0 g (2.5 oz)
Volume

39.0 cm

3

(2.38 in3)
Battery life 9 years

Power source

b

Lithium ion rechargeable battery

Temperature limitation –18 °C to +52 °C (0 °F to +126 °F)

Serial number model designator

c

Radiopaque identification (ID) code

a

All measurements are approximate.

b

The neurostimulator is not shipped with a full battery charge. Refer to the charging system user manual
for neurostimulator charging instructions.

c

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

d

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

NMC

d

NMA

97713 2016-06-01  English 9

Table 2. Physical characteristics of the RestoreAdvanced SureScan MRI Model 97713

neurostimulator

a

Description Value

neurostimulator is implanted and is not to be used for concluding that the entire neurostimulation system
is full-body MRI scan eligible.

Table 3. Material of components in the RestoreAdvanced SureScan MRI Model 97713

package

Components Material Material contacts

human tissue

Neurostimulator

Case Titanium Yes
Connector block Polyurethane, silicone rubber,

silicone medical adhesive

Yes

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

Torque wrench

Handle Polyetherimide Yes
Shaft Stainless steel 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.

10 English  97713 2016-06-01

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. MR scans performed under different
conditions can result in patient injury or damage to the implantable device.

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.

▪

97713 2016-06-01  English 11

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.

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

12 English  97713 2016-06-01

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.

97713 2016-06-01  English 13

Socket II
(Electrodes 8-15)

Socket I
(Electrodes 0-7)

Extension
or Lead 1

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.

Extension
or Lead 2

14 English  97713 2016-06-01

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 11.)

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.

97713 2016-06-01  English 15

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

2.

Insert the neurostimulator and excess lead or extension coils into the subcutaneous
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 white surface facing outward. If

▪

implanted with the white surface facing inward, the neurostimulator cannot
be charged.

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

16 English  97713 2016-06-01

neurostimulator.

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

1.

To ensure that you have properly connected each extension or lead to the
neurostimulator, use the clinician programmer to confirm the integrity of the
connected system.

Caution:

To use the nonsterile clinician programmer in a sterile field, place a
sterile barrier between the patient and the programming head to prevent
infection. Do not sterilize any part of the clinician programmer. Sterilization may
damage the programmer.

Note:

The neurostimulator should be in the pocket during system interrogation for

integrity to ensure proper readings.
If the system integrity test results are not acceptable, refer to "Connecting the

extension or lead to the neurostimulator" on page 13.

2.

Program the basic stimulation parameters and check the battery status; if applicable,
check the electrode impedances to rule out a short or open circuit.

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.

97713 2016-06-01  English 17

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.
Tel. [phone]
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]
Fax [phone]

Slovakia:

Medtronic Slovakia, o.z.
Tel. [phone]
Fax [phone]

Spain:

Medtronic Ibérica, S.A.
Tel. [phone]
Fax [phone]

Sweden:

Medtronic AB
Tel. [phone]
Fax [phone]

Switzerland:

Medtronic (Schweiz) AG
Tel. [phone]
Fax [phone]

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

*M940099A007*

© Medtronic, Inc. 2016
All Rights Reserved

M940099A007 Rev A