St. Jude Medical Protege User manual

Clinician’s Manual
Protege™
Implantable Pulse Generator
37-4832-01A.indd A37-4832-01A.indd A 1/30/2014 4:39:11 PM1/30/2014 4:39:11 PM

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
service marks of St.Jude Medical, Inc. and its related companies. © 2013 St.Jude Medical, Inc. All
rights reserved.
For a listing of patents for St.Jude Medical neuromodulation products, visit
http://patent.sjmneuro.com.
37-4832-01A.indd B37-4832-01A.indd B 1/30/2014 4:39:15 PM1/30/2014 4:39:15 PM

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
37-4832-01A.indd i37-4832-01A.indd i 1/30/2014 4:39:16 PM1/30/2014 4:39:16 PM

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
37-4832-01A.indd ii37-4832-01A.indd ii 1/30/2014 4:39:16 PM1/30/2014 4:39:16 PM

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.
37-4832-01A.indd 137-4832-01A.indd 1 1/30/2014 4:39:16 PM1/30/2014 4:39:16 PM

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
37-4832-01A.indd 237-4832-01A.indd 2 1/30/2014 4:39:16 PM1/30/2014 4:39:16 PM

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).
37-4832-01A.indd 337-4832-01A.indd 3 1/30/2014 4:39:17 PM1/30/2014 4:39:17 PM

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.
37-4832-01A.indd 437-4832-01A.indd 4 1/30/2014 4:39:17 PM1/30/2014 4:39:17 PM

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.
37-4832-01A.indd 537-4832-01A.indd 5 1/30/2014 4:39:17 PM1/30/2014 4:39:17 PM

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.
37-4832-01A.indd 637-4832-01A.indd 6 1/30/2014 4:39:17 PM1/30/2014 4:39:17 PM

Protege IPG Clinician’s Manual 7
Sterilization and Storage
Single-use, sterile device. The implanted components of this neurostimulation
system are intended for a single use only. Sterile components in this kit have
been sterilized using ethylene oxide (EtO) gas before shipment and are supplied
in sterile packaging to permit direct introduction into the sterile field. Do not
resterilize or reimplant an explanted system for any reason because of the risk of
infection and device malfunction.
Storage environment. Store components and their packaging where they will not
come in contact with liquids of any kind.
Handling and Implementation
Expiration date. An expiration date (or “use-before” date) is printed on the
packaging. Do not use the system if the use-before date has expired.
Care and handling of components. Use extreme care when handling system
components prior to implantation. Excessive heat, excessive traction, excessive
bending, excessive twisting, or the use of sharp instruments may damage and
cause failure of the components.
37-4832-01A.indd 737-4832-01A.indd 7 1/30/2014 4:39:17 PM1/30/2014 4:39:17 PM

8 Protege IPG Clinician’s Manual
Package or component damage. Do not implant a device if the sterile package
or components show signs of damage, if the sterile seal is ruptured, or if
contamination is suspected for any reason. Return any suspect components to
St.Jude Medical for evaluation.
System testing. To ensure correct operation, the system should always be tested
after implantation and before the patient leaves the surgery suite.
Device modification. The equipment is not serviceable by the customer. To
prevent injury or damage to the system, do not modify the equipment. If needed,
return the equipment to St.Jude Medical for service.
Hospital and Medical Environments
High-output ultrasonics and lithotripsy. The use of high-output devices, such
as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry
of an implanted IPG. If lithotripsy must be used, do not focus the energy near
theIPG.
37-4832-01A.indd 837-4832-01A.indd 8 1/30/2014 4:39:17 PM1/30/2014 4:39:17 PM

Protege IPG Clinician’s Manual 9
Ultrasonic scanning equipment. The use of ultrasonic scanning equipment may
cause mechanical damage to an implanted neurostimulation system if used
directly over the implanted system.
External defibrillators. The safety of discharge of an external defibrillator on
patients with implanted neurostimulation systems has not been established.
Therapeutic radiation. Therapeutic radiation may damage the electronic circuitry
of an implanted neurostimulation system, although no testing has been done and
no definite information on radiation effects is available. Sources of therapeutic
radiation include therapeutic X rays, cobalt machines, and linear accelerators. If
radiation therapy is required, the area over the implanted IPG should be shielded
with lead.
Home and Occupational Environments
Electromagnetic interference (EMI). Certain commercial electrical equipment
(for example, arc welders, induction furnaces, and resistance welders),
communication equipment (for example, microwave transmitters, linear
power amplifiers, and high power amateur transmitters), and high voltage
37-4832-01A.indd 937-4832-01A.indd 9 1/30/2014 4:39:17 PM1/30/2014 4:39:17 PM

10 Protege IPG Clinician’s Manual
power lines may generate sufficient EMI to interfere with the operation of the
neurostimulation system if approached too closely.
Adverse Effects
In addition to those risks commonly associated with surgery, the following risks
are associated with implanting or using this IPG:
Unpleasant sensations or motor disturbances, including involuntary
movement, caused by stimulation at high outputs (If either occurs, turn off
your IPG immediately.)
Stimulation in unwanted places
Paralysis, weakness, clumsiness, numbness, or pain below the level of
theimplant
Persistent pain at the IPG site
Seroma (mass or swelling) at the IPG site
Allergic or rejection response to implant materials
Implant migration or skin erosion around the implant
37-4832-01A.indd 1037-4832-01A.indd 10 1/30/2014 4:39:17 PM1/30/2014 4:39:17 PM

Protege IPG Clinician’s Manual 11
Battery failure
37-4832-01A.indd 1137-4832-01A.indd 11 1/30/2014 4:39:17 PM1/30/2014 4:39:17 PM

12 Protege IPG Clinician’s Manual
Product Description
The Protege™ IPG is a rechargeable, electronic device designed to be connected
to one or more extensions or leads with up to 16 electrodes total. It is powered
by a hermetically sealed battery within a titanium case and uses microelectronic
circuitry to generate constant-current electrical stimulation. The IPG can deliver
stimulation with a single program or with multiple programs (called MultiStim™
programs). New features can be introduced to the Protege system via software
updates allowing for upgraded technology to be used. A St. Jude Medical external
programmer may be needed for certain types of software updates to this product.
NOTE: For more information about the neurostimulation system, see the clinician’s programming
and reference manual for this system.
37-4832-01A.indd 1237-4832-01A.indd 12 1/30/2014 4:39:17 PM1/30/2014 4:39:17 PM

Protege IPG Clinician’s Manual 13
Contents of Package
In addition to the product documentation, the Protege™ IPG kit (Model 3789)
contains the following items:
1 IPG
1 pocket sizer
1 torque wrench (Model 1101)
2 port plugs (Model 1111)
1 tunneling tool (Model 1112)
37-4832-01A.indd 1337-4832-01A.indd 13 1/30/2014 4:39:17 PM1/30/2014 4:39:17 PM

14 Protege IPG Clinician’s Manual
Identifying the IPG
Using standard X-ray procedures, you can view the code that identifies the
manufacturer and model number of the IPG in the header of the IPG. For the
Protege™ IPG, the code is SJM ZNN, where Z designates Model 3789 and NN
designates the last two digits of the year of manufacture. For example, SJM Z14
designates a Protege IPG (Model 3789) manufactured in 2014.
Figure 1: Location of IPG code
37-4832-01A.indd 1437-4832-01A.indd 14 1/30/2014 4:39:17 PM1/30/2014 4:39:17 PM

Protege IPG Clinician’s Manual 15
Directions for Use
Read this section for directions for use related to the IPG. For directions for use
for other system components not covered in this document, see the clinician’s
manual for the appropriate device.
NOTE: Well in advance of the surgical procedure, authorize the programmer to the IPG while the
IPG is in its sterile packaging to ensure that it is functional.
Creating an IPG Pocket
The following steps outline the suggested procedure to create an IPG pocket:
1. Determine the site for the IPG, ensuring that the lead is long enough to
reach the pocket and provide a strain relief loop.
NOTE: The IPG should be located in an area that the patient can easily reach with the programming
wand. Common sites for implantation are: along the midaxillary line, in the upper buttock along
the posterior axillary line (taking care to avoid the belt line), and in the area over the abdomen
just below the lowermost rib. To ensure a flat area is selected, you can mark a flat area prior to the
surgical procedure while the patient is in a sitting position.
37-4832-01A.indd 1537-4832-01A.indd 15 1/30/2014 4:39:19 PM1/30/2014 4:39:19 PM

16 Protege IPG Clinician’s Manual
CAUTION: Do not place the IPG deeper than 2.25 cm (0.9 in) because
the patient programmer and charger may not communicate efficiently with
the IPG and the charger may not charge efficiently.
2. Create the pocket so that the IPG is parallel to the skin surface and no
deeper than 2.25 cm (0.9 in) below the skin surface.
3. Insert and remove the pocket sizer to ensure that the pocket is large enough
to accommodate the IPG, allowing enough extra room for a strain relief loop
for each lead or extension.
37-4832-01A.indd 1637-4832-01A.indd 16 1/30/2014 4:39:19 PM1/30/2014 4:39:19 PM