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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