Medtronic 3058 User Manual

InterStim® Therapy

InterStim® II Model 3058 Neurostimulator InterStim

Implant manual

Model 3023 Neurostimulator

3058 3023

Rx only

2006 (3058) 1995 (3023)

Explanation of symbols on product or package labeling

STERILIZE

XXX °F

XX °C

-XX °F

-XX °C

Open here

Do not reuse

STERILE

Sterilized using ethylene oxide

Use by

Serial number

Do not use if package is damaged

Conformité Européenne (European Conformity). This symbol means that the device fully complies with AIMD Directive 90/385/EEC (NB 0123).

Date of Manufacture

Consult instructions for use

Do not resterilize

Temperature limitation

Manufacturer

REP

Authorized representative in the Europe2016an community

For USA audiences only

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Medtronic, InterStim, and SoftStart/Stop are trademarks of Medtronic, Inc., registered in the U.S. and other countries.

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Table of contents

Introduction 5

Device description 5 Package contents 5 Patient registration and identification card 5

Device specifications 5

X-Ray identification 8

Instructions for use: Model 3058 9

Verifying neurostimulator operation 9 Creating a pocket for the Model 3058 Neurostimulator 9 Connecting the lead to the Model 3058 Neurostimulator 10 Implanting the Model 3058 Neurostimulator 13 Completing the implant procedure 14 Replacing the Model 3058 Neurostimulator 14 Device description 15 Package contents 15 Patient registration and identification card 15

Device specifications 15

X-Ray identification 18

Instructions for use: Model 3023 19

Verifying neurostimulator operation 19 Creating a pocket for the Model 3023 Neurostimulator 19 Connecting the extension to the Model 3023 Neurostimulator 20

• Refer to the appropriate Information for Prescribers (IFP) booklet for contraindications, warnings, precautions, adverse events summary, individualization of treatment, patient selection, use in specific populations, resterilization, and component disposal.

• Refer to the Indications Insert for indications and related information.

• Refer to the System Overview and Compatibility Insert for information regarding device compatibility.

Note: Some product models described in this manual may not be available in all geographies.

•

Refer to the Clinical Summary for information on the clinical study results for

InterStim Therapy and for a complete summary of adverse events.

Refer to the Limited Warranty and Special Notice Insert for warranty information.

•

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

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Implanting the Model 3023 Neurostimulator 23 Completing the implant procedure 24 Replacing the Model 3023 Neurostimulator 24

Declaration of conformity 25

Control magnet 26

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InterStim II Model 3058 Neurostimulator

Introduction

This manual includes information about two devices used separately as part of a Medtronic InterStim System. The Medtronic InterStim II Model 3058 Neurostimulator is used with a lead and the Medtronic InterStim Model 3023 Neurostimulator is used with a lead and an extension.

InterStim II Model 3058 Neurostimulator

Device description

The Medtronic InterStim II Model 3058 Neurostimulator is part of a neurostimulation system for InterStim Therapy.

Package contents

ƒ Neurostimulator ƒ Torque wrench ƒ Product literature

Patient registration and identification card

The implant registration form registers the device and creates a record of the device in Medtronic’s implant data system.

A patient identification card is package with this device. Advise the patient to carry the identification card at all times.

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

card will be mailed to the patient when Medtronic receives the implant registration form.

Device specifications

The neurostimulator is a programmable device that accommodates a lead through which a stimulation program is delivered.

Refer to Table 1 for shipping, operating, and power-on-reset values. Refer to Table 2 for physical characteristics. Refer to Table 3 for materials of package components.

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InterStim II Model 3058 Neurostimulator

Table 1. Shipping, operating, and power-on-reset (POR) values for the

Medtronic InterStim II Model 3058 Neurostimulator

Programmable Parameters Shipping Operating POR

Amplitude

Normal Resolution Upper Limit Lower Limit

Fine Resolution Upper Limit Lower Limit

Rate 14 Hz 49 values

0.0 V

---

100 mV steps

8.5 V maximum

0.0 V minimum

50 mV steps

6.35 V maximum

0.0 V minimum

0.0 V

---

31 Hz

(from 2.1 to 130 Hz)

Pulse width 210 μs Increments of 30 μs steps

450 μs maximum 60 μs minimum

210 μs

Operating Mode Continuous Continuous or Cycling Continuous

Cycle On/Cycle Off time

SoftStart/Stop

Output On/Off

Polarity

All values are approximate.

Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF. POR can occur when there is a temporary fluctuation in battery voltage (eg, due to electromagnetic interference during electrocautery or defibrillation) or the battery is depleted. When POR occurs, the serial number is reset to a nominal value and must be entered with the clinician programmer.

Cycle On and Cycle Off time must be greater than or equal to the SoftStart/Stop time.

SoftStart/Stop must be less than or equal to the Cycle On and Cycle Off time.

If case electrode is positive, electrodes 0-3 may be programmed to Off or – only.

Electrode Number

0 1 2 3 Case

0.1 sec 0.1 sec to 24 hr 0.1 sec

Off 1, 2, 4, 8, 15, 30 sec, or

Off

Off On or Off Off

– Off Off +

Off

Off, + or – Off, + or – Off, + or – Off, + or – Off or +

Off

– Off Off + Off

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InterStim II Model 3058 Neurostimulator

Table 2. Physical characteristics of the InterStim II Model 3058

Neurostimulator.

Description Value

Height 44 mm (1.7 in)

Length 51 mm (2 in)

Thickness 7.7 mm (0.3 in)

Weight 22 g (0.77 oz)

Volume 14 cm

(0.85 in3)

External shield Titanium

Power source

1.3 Amp Hours, 3.2 V Lithium silver vanadium oxide hybrid

Storage temperature -18 °C to 52 °C (0 °F to 125 °F)

Serial Number

Radiopaque Identification (ID)

All measurements are approximate.

The power source is hermetically sealed within the case.

The serial number is the radiopaque ID followed by a number. The clinician programmer

NJY

displays the entire number beginning with the radiopaque ID.

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InterStim II Model 3058 Neurostimulator

X-Ray identification

Radiopaque identification permits the determination of manufacturer and neurostimulator model number (Figure 1). With standard x-ray procedures, the code appears as black characters on white background. The Medtronic symbol identifies Medtronic as the manufacturer. For the Medtronic InterStim II Model 3058 Neurostimulator, the designated characters are NJY.

Figure 1. The InterStim II Model 3058 Neurostimulator

radiopaque code block.

Table 3. Material of components in the Model 3058 package.

Structure Material Material Contacts Human Tissue

Case

Connector Urethane Yes

Grommets, seals, strain relief

Setscrew and electrical contacts

Adhesive Silicone

Torque wrench

Handle Shaft

The electronics and power source are hermetically sealed within the case.

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Titanium Yes

Silicone rubber Yes

Titanium Yes

adhesive

Polyetherimide Stainless steel

Yes

Yes Yes

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