St. Jude Medical Protege Bedienungsanleitung

Clinician’s Manual

Protege™

Implantable Pulse Generator

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CAUTION: Federal law restricts this device to sale by or on the order of a

physician.

Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St.Jude Medical

or one of its subsidiaries. ST.JUDE MEDICAL and the nine-squares symbol are trademarks and

rights reserved.

For a listing of patents for St.Jude Medical neuromodulation products, visit

http://patent.sjmneuro.com.

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Protege IPG Clinician’s Manual i

Contents

Prescription and Safety Information . . . . . . . . . . . . . . . . . . . . . . . 1

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Contraindications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Warnings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

Precautions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Adverse Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Contents of Package . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Identifying the IPG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Directions for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Clinician’s Manual

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ii Protege IPG Clinician’s Manual

Creating an IPG Pocket . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Tunneling to the Pocket . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Connecting a Lead or Extension to the IPG. . . . . . . . . . . . . . . . . 21

Implanting the IPG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Replacing the IPG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

Disposing of Explanted Components . . . . . . . . . . . . . . . . . . . . . 30

Maintaining the IPG Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Recharging the IPG Battery. . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Preserving the IPG When Not in Use . . . . . . . . . . . . . . . . . . . . . 33

Customer Service Information . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Appendix A: Product Specifications . . . . . . . . . . . . . . . . . . . . . . . 35

Protege IPG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Appendix B: Regulatory Statements . . . . . . . . . . . . . . . . . . . . . . . 37

Statement of FCC Compliance (FCC ID:PX 2001) . . . . . . . . . . . . 37

Appendix C: Symbols and Definitions . . . . . . . . . . . . . . . . . . . . . . 39

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Protege IPG Clinician’s Manual 1

Prescription and Safety Information

Read this section to gather important prescription and safety information.

Intended Use

This rechargeable neurostimulation system is designed to deliver low-intensity

electrical impulses to nerve structures. The system is intended to be used with

leads and associated extensions that are compatible with the system.

Indications for Use

This neurostimulation system is indicated as an aid in the management of

chronic, intractable pain of the trunk and/or limbs, including unilateral or

bilateral pain associated with the following: failed back surgery syndrome and

intractable low back and leg pain.

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2 Protege IPG Clinician’s Manual

Contraindications

This system is contraindicated for patients who are unable to operate the system

or who have failed to receive effective pain relief during trial stimulation.

Warnings

The following warnings apply to the use of this neurostimulation system.

Poor surgical risks. Neurostimulation should not be used on patients who are poor

surgical risks or patients with multiple illnesses or active general infections.

Diathermy therapy. Do not use short-wave diathermy, microwave diathermy,

or therapeutic ultrasound diathermy (all now referred to as diathermy) on

patients implanted with a neurostimulation system. Energy from diathermy can

be transferred through the implanted system and cause tissue damage at the

location of the implanted electrodes, resulting in severe injury or death.

Diathermy is further prohibited because it may also damage the neurostimulation

system components. This damage could result in loss of therapy, requiring

additional surgery for system implantation and replacement. Injury or damage can

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Protege IPG Clinician’s Manual 3

occur during diathermy treatment whether the neurostimulation system is turned

on or off.

Electrosurgery devices. Electrosurgery devices should not be used in close

proximity to an implanted neurostimulation system. Contact between an

active electrode and an implanted IPG, lead, or extension can cause severe

injury to the patient. If use of electrocautery is necessary, ﬁrst turn off the

neurostimulationsystem.

Implanted cardiac systems. Physicians need to be aware of the risk and possible

interaction between a neurostimulation system and an implanted cardiac system,

such as a pacemaker or deﬁbrillator. Electrical pulses from a neurostimulation

system may interact with the sensing operation of an implanted cardiac system,

causing the cardiac system to respond inappropriately. To minimize or prevent

the implanted cardiac system from sensing the output of the neurostimulation

system, (1) verify that the neurostimulation system is not interfering with the

functions of the implanted cardiac system and (2) avoid programming either

device in a unipolar mode (using the device’s can as an anode).

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4 Protege IPG Clinician’s Manual

Magnetic resonance imaging (MRI). Patients with implanted neurostimulation

systems should not be subjected to MRI. The electromagnetic ﬁeld generated

by an MRI may forcefully dislodge implanted components, damage the device

electronics, and induce voltage through the lead that could jolt or shock

thepatient.

Device components. The use of non-St.Jude Medical components with this

system may result in damage to the system and increased risk to the patient.

Case damage. Do not handle the IPG if the case is pierced or ruptured because

severe burns could result from exposure to battery chemicals.

IPG disposal. Return all explanted IPGs to St.Jude Medical for safe disposal (see

“Disposing of Explanted Components”). IPGs contain lithium ion batteries as well

as other potentially hazardous materials. Do not crush, puncture, or burn the IPG

because explosion or ﬁre may result.

Product materials. Neurostimulation systems have materials that come in contact

or may come in contact with tissue. A physician should determine whether or not

a patient may have an allergic reaction to these materials before the system is

implanted.

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Protege IPG Clinician’s Manual 5

Precautions

The following precautions apply to the use of this neurostimulation system.

General Precautions

Physician training. Implanting physicians should be experienced in the diagnosis

and treatment of chronic pain syndromes and have undergone surgical and device

implantation training.

Patient selection. It is extremely important to select patients appropriately

for neurostimulation. Thorough psychiatric screening should be performed.

Patients should not be dependent on drugs and should be able to operate the

neurostimulation system.

Infection. Follow proper infection control procedures. Infections related to system

implantation might require that the device be explanted.

Implantation of two systems. If two systems are implanted, ensure that at

least 20cm (8in) separates the implanted IPGs to minimize the possibility of

interference during programming.

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6 Protege IPG Clinician’s Manual

Implant heating. While recharging an IPG, patients may perceive an increase in

temperature. In patients who have areas of increased sensitivity to heat, consider

placing the implant where the patient has normal sensation.

Theft detectors and metal screening devices. Certain types of antitheft devices,

such as those used at entrances or exits of department stores, libraries, and

other public establishments, and airport security screening devices may affect

stimulation. Patients who are implanted with nonadjacent multiple leads and

patients who are sensitive to low stimulation thresholds may experience a

momentary increase in their perceived stimulation, which has been described

by some patients as uncomfortable or jolting. Patients should use caution when

approaching such a device and should request assistance to bypass the device.

If they must proceed through the device, patients should turn off the IPG and

proceed with caution, being sure to move through the detector quickly.

Mobile phones. The effect of mobile phones on neurostimulation systems is

unknown; patients should avoid placing mobile phones directly over the system.

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