Boston Scientific DYNAGEN CRT-D User manual

PHYSICIAN’S TECHNICAL MANUAL
DYNAGEN™CRT-D, DYNAGEN™X4 CRT-D,
INOGEN™CRT-D, INOGEN™X4 CRT-D,
ORIGEN™CRT-D, ORIGEN™X4 CRT-D
CARDIAC RESYNCHRONIZATION THERAPY
DEFIBRILLATOR
Model G150, G151, G154, G156, G158, G140, G141, G146, G148, G050, G051,
G056, G058
CAUTION: Federal law (USA)
restricts this device to sale by
or on the order of a physician
trained or experienced in
device implant and follow-up
procedures.

Table of Contents
Additional Technical Information..................................................................................................... 1
Device Description.......................................................................................................................... 1
Related Information ........................................................................................................................ 3
Intended Audience ................................................................................................................4
Indications and Usage .................................................................................................................... 4
Contraindications............................................................................................................................ 4
Warnings ........................................................................................................................................ 4
Precautions..................................................................................................................................... 7
Supplemental Precautionary Information ..................................................................................... 19
Post-Therapy Pulse Generator Follow Up .......................................................................... 19
Transcutaneous Electrical Nerve Stimulation (TENS)......................................................... 20
Electrocautery and Radio Frequency (RF) Ablation............................................................ 22
Ionizing Radiation................................................................................................................ 23
Elevated Pressures ............................................................................................................. 24
Potential Adverse Events ............................................................................................................. 25
Mechanical Specifications ............................................................................................................ 28
Items Included in Package ........................................................................................................... 31
Symbols on Packaging ................................................................................................................. 31
Characteristics as Shipped........................................................................................................... 35
X-Ray Identifier............................................................................................................................. 37
Federal Communications Commission (FCC) .............................................................................. 38
Pulse Generator Longevity........................................................................................................... 39
Warranty Information .................................................................................................................... 41
Product Reliability......................................................................................................................... 42
Patient Counseling Information ....................................................................................................42
Patient Handbook................................................................................................................ 43
Lead Connections......................................................................................................................... 44

Implanting the Pulse Generator.................................................................................................... 48
Step A: Check Equipment ................................................................................................ 49
Step B: Interrogate and Check the Pulse Generator ........................................................ 49
Step C: Implant the Lead System..................................................................................... 50
Step D: Take Baseline Measurements ............................................................................. 51
Step E: Form the Implantation Pocket.............................................................................. 53
Step F: Connect the Leads to the Pulse Generator.......................................................... 55
Step G: Evaluate Lead Signals......................................................................................... 59
Step H: Program the Pulse Generator.............................................................................. 61
Step I: Test for Ability to Convert Ventricular Fibrillation and Inducible Arrhythmias ........ 62
Step J: Implant the Pulse Generator ................................................................................ 64
Step K: Complete and Return the Implantation Form....................................................... 65
Bidirectional Torque Wrench......................................................................................................... 65
Follow Up Testing ......................................................................................................................... 67
Predischarge Follow Up ...................................................................................................... 68
Routine Follow Up............................................................................................................... 68
Explantation.................................................................................................................................. 69

ADDITIONAL TECHNICAL INFORMATION
For additional technical reference guides, go to www.bostonscientific.com/ifu.
DEVICE DESCRIPTION
This manual contains information about the DYNAGEN, INOGEN, and ORIGEN families of cardiac
resynchronization therapy defibrillators (CRT-Ds) (specific models are listed in "Mechanical Specifications"
on page 28).
NOTE: Specific features discussed in this manual may not apply to all models.
Therapies
These pulse generators have a small, thin, physiologic shape that minimizes pocket size and may minimize
device migration. They provide a variety of therapies, including:
• Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac
death (SCD) such as VT and VF
• Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular
contractions through biventricular electrical stimulation
• Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide
cardiac rate support after defibrillation therapy
Cardioversion/defibrillation therapies include:
• A range of low- and high-energy shocks using a biphasic waveform
1

• The choice of multiple shock vectors:
– Distal shock electrode to proximal shock electrode and pulse generator case (TRIAD electrode
system)
– Distal shock electrode to proximal shock electrode (RV Coil to RA Coil)
– Distal shock electrode to pulse generator case (RV Coil to Can)
Leads
The pulse generator has independently programmable outputs and accepts one or more of the following
leads, depending on the model:
•OneIS-1
1atrial lead
• One LV-1 unipolar or bipolar left ventricular lead
• One IS-1 unipolar or bipolar left ventricular lead
• One compatible IS42quadripolar left ventricular lead3
• One DF-1/IS-14cardioversion/defibrillation lead
• One DF4-LLHH or DF4-LLHO5multipolar connector cardioversion/defibrillation lead
Leads with either a GDT-LLHH/LLHO or DF4-LLHH/LLHO label are equivalent and are compatible with a
device containing either a GDT-LLHH or DF4-LLHH port.
The pulse generator and the leads constitute the implantable portion of the pulse generator system.
1. IS-1 refers to the international standard ISO 5841-3:2000.
2. IS4 refers to the international standard ISO 27186:2010.
3. Compatibility with St. Jude Quartet IS4 lead has been demonstrated through testing.
4. DF-1 refers to the international standard ISO 11318:2002.
5. DF4 refers to the international standard ISO 27186:2010.
2

PRM System
These pulse generators can be used only with the ZOOM LATITUDE Programming System, which is the
external portion of the pulse generator system and includes:
• Model 3120 Programmer/Recorder/Monitor (PRM)
• Model 3140 ZOOM Wireless Transmitter
• Model 2868 ZOOMVIEW Software Application
• Model 6577 Accessory Telemetry Wand
You can use the PRM system to do the following:
• Interrogate the pulse generator
• Program the pulse generator to provide a variety of therapy options
• Access the pulse generator’s diagnostic features
• Perform noninvasive diagnostic testing
• Access therapy history data
RELATED INFORMATION
Refer to the lead’s instruction manual for implant information, general warnings and precautions, indications,
contraindications, and technical specifications. Read this material carefully for implant procedure instructions
specific to the chosen lead configurations.
Refer to the PRM system Operator’s Manual for specific information about the PRM such as setup,
maintenance, and handling.
This device is designed to be LATITUDE enabled; LATITUDE availability varies by region.
3

Intended Audience
This literature is intended for use by professionals trained or experienced in device implant and/or follow-up
procedures.
INDICATIONS AND USAGE
These Boston Scientific Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients
with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet
any one of the following classifications:
• Moderate to severe heart failure (NYHA Class III-IV) with EF 35% and QRS duration 120 ms
• Left bundle branch block (LBBB) with QRS duration 130 ms, EF 30%, and mild (NYHA Class II)
ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure
CONTRAINDICATIONS
There are no contraindications for this device.
WARNINGS
General
• Labeling knowledge. Read this manual thoroughly before implantation to avoid damage to the pulse
generator and/or lead. Such damage can result in patient injury or death.
• For single patient use only. Do not reuse, reprocess, or resterilize. Reuse, reprocessing, or
resterilization may compromise the structural integrity of the device and/or lead to device failure which, in
turn, may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also create
a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not
limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the
device may lead to injury, illness, or death of the patient.
4

• Backup defibrillation protection. Always have external defibrillation equipment available during
implant and electrophysiologic testing. If not terminated in a timely fashion, an induced ventricular
tachyarrhythmia can result in the patient’s death.
• Resuscitation availability. Ensure that an external defibrillator and medical personnel skilled in CPR are
present during post-implant device testing should the patient require external rescue.
• Patch leads. Do not use defibrillation patch leads with the pulse generator system, or injury to the
patient may occur.
• Separate pulse generator. Do not use this pulse generator with another pulse generator. This
combination could cause pulse generator interaction, resulting in patient injury or a lack of therapy delivery.
Handling
• Avoid shock during handling. Program the pulse generator Tachy Mode(s) to Off during implant,
explant, or postmortem procedures to avoid inadvertent high voltage shocks.
• Do not kink leads. Do not kink, twist, or braid the lead with other leads as doing so could cause lead
insulation abrasion damage or conductor damage.
• Handling the lead without Connector Tool. For leads that require the use of a Connector Tool, use
caution handling the lead terminal when the Connector Tool is not present on the lead. Do not directly
contact the lead terminal with any surgical instruments or electrical connections such as PSA (alligator)
clips, ECG connections, forceps, hemostats, and clamps. This could damage the lead terminal, possibly
compromising the sealing integrity and result in loss of therapy or inappropriate therapy, such as a
short within the header.
• Handling the terminal while tunneling. Do not contact any other portion of the DF4–LLHH or
DF4–LLHO lead terminal, other than the terminal pin, even when the lead cap is in place.
Do not contact any other portion of the IS4–LLLL lead terminal, other than the terminal pin, even when
the lead cap is in place.
5

• Appropriate lead connections. When implanting a system which uses both a DF4-LLHH/LLHO and
IS4-LLLL lead, ensure that the leads are inserted and secured in the appropriate ports. Inserting a lead
into an incorrect port will result in unanticipated device behavior (potentially leaving the patient without
effective therapy).
Programming and Device Operations
• Atrial tracking modes. Do not use atrial tracking modes in patients with chronic refractory atrial
tachyarrhythmias. Tracking of atrial arrhythmias could result in ventricular tachyarrhythmias.
• Atrial-only modes. Do not use atrial-only modes in patients with heart failure because such modes do
not provide CRT.
• Ventricular sensing. Left ventricular lead dislodgement to a position near the atria can result in atrial
oversensing and left ventricular pacing inhibition.
•SlowVT.Physicians should use medical discretion when implanting this device in patients who present
with slow VT. Programming therapy for slow monomorphic VT may preclude CRT delivery at faster rates
if these rates are in the tachyarrhythmia zones.
Post-Implant
• Protected environments. Advise patients to seek medical guidance before entering environments that
could adversely affect the operation of the active implantable medical device, including areas protected
by a warning notice that prevents entry by patients who have a pulse generator.
• Magnetic Resonance Imaging (MRI) exposure. Do not expose a patient to MRI scanning. Strong
magnetic fields may damage the pulse generator and/or lead system, possibly resulting in injury to
or death of the patient.
•Diathermy.Do not subject a patient with an implanted pulse generator and/or lead to diathermy since
diathermy may cause fibrillation, burning of the myocardium, and irreversible damage to the pulse
generator because of induced currents.
6

• Ensure PTM is enabled. If desired, ensure that Patient Triggered Monitor is enabled prior to sending
the patient home by confirming the Magnet Response is programmed to Store EGM. If the feature is
inadvertently left in the Inhibit Therapy setting, the patient could potentially disable tachyarrhythmia
detection and therapy.
• Magnet Response set to Inhibit Therapy. Once the Patient Triggered Monitor feature has been
triggered by the magnet and an EGM has been stored, or after 60 days have elapsed from the day
that Store EGM was enabled, the Magnet Response programming automatically will be set to Inhibit
Therapy. When this happens, the patient should not apply the magnet because tachyarrhythmia therapy
could be inhibited.
PRECAUTIONS
Clinical Considerations
• Pacemaker-mediated tachycardia (PMT). Programming minimum PVARP less than retrograde V–A
conduction may increase the likelihood of a PMT.
Sterilization and Storage
• If package is damaged. The blister trays and contents are sterilized with ethylene oxide gas before
final packaging. When the pulse generator and/or lead is received, it is sterile provided the container is
intact. If the packaging is wet, punctured, opened, or otherwise damaged, return the pulse generator
and/or lead to Boston Scientific.
• If device is dropped. Do not implant a device which has been dropped while outside of its intact shelf
package. Do not implant a device which has been dropped from a height of more than 24 inches (61 cm)
while within its intact shelf package. Sterility, integrity and/or function cannot be guaranteed under these
conditions and the device should be returned to Boston Scientific for inspection.
7

• Storage temperature and equilibration. Recommended storage temperatures are 0°C–50°C
(32°F–122°F). Allow the device to reach a proper temperature before using telemetry communication
capabilities, programming or implanting the device because temperature extremes may affect initial
device function.
•Devicestorage.Store the pulse generator in a clean area away from magnets, kits containing magnets,
and sources of EMI to avoid device damage.
•Usebydate.Implant the pulse generator and/or lead before or on the USE BY date on the package
label because this date reflects a validated shelf life. For example, if the date is January 1, do not
implant on or after January 2.
Implantation
• Expected benefits. Determine whether the expected device benefits provided by programmable options
outweigh the possibility of more rapid battery depletion.
• Evaluate patient for surgery. There may be additional factors regarding the patient’s overall health
and medical condition that, while not related to device function or purpose, could render the patient a
poor candidate for implantation of this system. Cardiac health advocacy groups may have published
guidelines that may be helpful in conducting this evaluation.
• Lead compatibility. Prior to implantation, confirm the lead-to-pulse generator compatibility. Using
incompatible leads and pulse generators can damage the connector and/or result in potential adverse
consequences, such as undersensing of cardiac activity or failure to deliver necessary therapy.
• Telemetry wand. Make sure a sterile telemetry wand is available should loss of ZIP telemetry occur.
Verify that the wand can easily be connected to the programmer and is within reach of the pulse generator.
• Line-powered equipment. Exercise extreme caution if testing leads using line-powered equipment
because leakage current exceeding 10 µA can induce ventricular fibrillation. Ensure that any line-powered
equipment is within specifications.
8

• Replacement device. Implanting a replacement device in a subcutaneous pocket that previously housed
a larger device may result in pocket air entrapment, migration, erosion, or insufficient grounding between
the device and tissue. Irrigating the pocket with sterile saline solution decreases the possibility of
pocket air entrapment and insufficient grounding. Suturing the device in place reduces the possibility of
migration and erosion.
• Do not bend the lead near the lead-header interface. Insert the lead terminal straight into the lead
port. Do not bend the lead near the lead-header interface. Improper insertion can cause insulation
or connector damage.
• Absence of a lead. The absence of a lead or plug in a lead port may affect device performance. If a
lead is not used, be sure to properly insert a plug in the unused port, and then tighten the setscrew
onto the plug.
• Electrode connections. Do not insert a lead into the pulse generator connector without taking the
following precautions to ensure proper lead insertion:
• Insert the torque wrench into the preslit depression of the seal plug before inserting the lead into the
port, to release any trapped fluid or air.
• Visually verify that the setscrew is sufficiently retracted to allow insertion. Use the torque wrench
to loosen the setscrew if necessary.
• Fully insert each lead into its lead port and then tighten the setscrew onto the terminal pin.
•Defibrillation lead impedance. If total shocking lead impedance during implant is less than 20 ,verify
the proximal coil is not in contact with the pulse generator surface. A measurement of less than 20 is
an indication of a short somewhere in the system. If repeated measurements show the total shocking
lead impedance is less than 20 , the lead and/or pulse generator may need to be replaced.
• Shunting energy. Do not allow any object that is electrically conductive to come into contact with the
lead or device during induction because it may shunt energy, resulting in less energy getting to the
patient, and may damage the implanted system.
9

• Do not suture directly over lead. Do not suture directly over the lead body, as this may cause structural
damage. Use the suture sleeve to secure the lead proximal to the venous entry site to prevent lead
movement.
Device Programming
• Device communication. Use only the designated PRM and software application to communicate
with this pulse generator.
• STAT PACE settings. When a pulse generator is programmed to STAT PACE settings, it will continue to
pace at the high-energy STAT PACE values if it is not reprogrammed. The use of STAT PACE parameters
will likely decrease device longevity.
• Biventricular pacing therapy. This device is intended to provide biventricular pacing therapy.
Programming the device to provide RV-only pacing, or programming the RV pace amplitude below the
pacing threshold (resulting in LV-only pacing), is not intended for the treatment of heart failure. The
clinical effects of LV-only or RV-only pacing for the treatment of heart failure have not been established.
• Pacing and sensing margins. Consider lead maturation in your choice of Pacing Amplitude, pacing
Pulse Width, and Sensitivity settings.
• An acute Pacing Threshold greater than 1.5 V or a chronic Pacing Threshold greater than 3 V can
result in loss of capture because thresholds may increase over time.
• An R-Wave Amplitude less than 5 mV or a P-Wave Amplitude less than 2 mV can result in
undersensing because the sensed amplitude may decrease after implantation.
• Pacing Lead Impedance should be greater than the programmed Low Impedance Limit (between
200 and 500 ) and less than the programmed High Impedance Limit (between 2000 and 3000 ).
• Proper programming of the lead configuration. If the Lead Configuration is programmed to Bipolar
when a unipolar lead is implanted, pacing will not occur.
10

• Proper programming of the shock vector. If the shock vector is programmed to RVcoil>>RAcoil and
the lead does not have an RA coil, shocking will not occur.
• Programming for supraventricular tachyarrhythmias (SVTs). Determine if the device and
programmable options are appropriate for patients with SVTs because SVTs can initiate unwanted
device therapy.
• AV Delay. To ensure a high percentage of biventricular pacing, the programmed AV Delay setting
must be less than the patient’s intrinsic PR interval.
• Adaptive-rate pacing. Rate Adaptive Pacing should be used with care in patients who are unable to
tolerate increased pacing rates.
• Ventricular refractory periods (VRPs) in adaptive-rate pacing. Adaptive-rate pacing is not limited by
refractory periods. A long refractory period programmed in combination with a high MSR can result in
asynchronous pacing during refractory periods since the combination can cause a very small sensing
window or none at all. Use Dynamic AV Delay or Dynamic PVARP to optimize sensing windows. If you
are entering a fixed AV Delay, consider the sensing outcomes.
• Atrial Tachy Response (ATR). ATR should be programmed to On if the patient has a history of atrial
tachyarrhythmias. The delivery of CRT is compromised because AV synchrony is disrupted if the ATR
mode switch occurs.
• Threshold test. During a manual LV Threshold test, RV Backup Pacing is unavailable.
• Left ventricular pacing only. The clinical effect of LV pacing alone for heart failure patients has not
been studied.
• Shock waveform polarity. For IS-1/DF-1 leads, never change the shock waveform polarity by physically
switching the lead anodes and cathodes in the pulse generator header—use the programmable Polarity
feature. Device damage or nonconversion of the arrhythmia post-operatively may result if the polarity
is switched physically.
11

• Tachy Mode to Off. To prevent inappropriate shocks, ensure that the pulse generator’s Tachy Mode is
programmed to Off when not in use and before handling the device. For tachyarrhythmia detection and
therapy, verify that the Tachy Mode is programmed to Monitor + Therapy.
• Atrial oversensing. Take care to ensure that artifacts from the ventricles are not present on the atrial
channel, or atrial oversensing may result. If ventricular artifacts are present in the atrial channel, the
atrial lead may need to be repositioned to minimize its interaction.
• ATR entry count. Exercise care when programming the Entry Count to low values in conjunction with
a short ATR Duration. This combination allows mode switching with very few fast atrial beats. For
example, if the Entry Count was programmed to 2 and the ATR Duration to 0, ATR mode switching could
occur on 2 fast atrial intervals. In these instances, a short series of premature atrial events could cause
the device to mode switch.
• ATR exit count. Exercise care when programming the Exit Count to low values. For example, if the
Exit Count was programmed to 2, a few cycles of atrial undersensing could cause termination of mode
switching.
• Proper programming without an atrial lead. If an atrial lead is not implanted (port is plugged instead),
or an atrial lead is abandoned but remains connected to the header, device programming should be
consistent with the number and type of leads actually in use.
• Left ventricular lead configuration. Proper programming of the LV coronary venous Lead Configuration
is essential for proper LV lead function. Program the Lead Configuration in accordance with the number
of electrodes on the LV lead; otherwise, erratic LV sensing, loss of LV pacing, or ineffective LV pacing
might occur.
• Left Ventricular Protection Period (LVPP). Use of a long LVPP reduces the maximum LV pacing
rate and may inhibit CRT at higher pacing rates.
12

• Sensing adjustment. Following any sensing range adjustment or any modification of the sensing lead,
always verify appropriate sensing. Programming Sensitivity to the highest value (lowest sensitivity) may
result in delayed detection or undersensing of cardiac activity. Likewise, programming to the lowest value
(highest sensitivity) may result in oversensing of non-cardiac signals.
• Patients hear tones coming from their devices. Patients should be advised to contact their physician
immediately if they hear tones coming from their device.
• Patient use of patient triggered monitor. Determine if the patient is capable of activating this feature
prior to being given the magnet and prior to enabling Patient Triggered Monitor. Remind the patient to
avoid strong magnetic fields so the feature is not inadvertently triggered.
• Patient initiate stored EGM. Consider having the patient initiate a stored EGM at the time Patient
Triggered Monitor is enabled to assist with patient education and feature validation. Verify the activation
of the feature on the Arrhythmia Logbook screen.
13

Environmental and Medical Therapy Hazards
• Avoid electromagnetic interference (EMI). Advise patients to avoid sources of EMI because EMI may
cause the pulse generator to deliver inappropriate therapy or inhibit appropriate therapy.
Moving away from the source of the EMI or turning off the source usually allows the pulse generator
to return to normal operation.
Examples of potential EMI sources are:
• Electrical power sources, arc welding or resistance welding equipment, and robotic jacks
• High voltage power distribution lines
• Electrical smelting furnaces
• Large RF transmitters such as radar
• Radio transmitters, including those used to control toys
• Electronic surveillance (antitheft) devices
• An alternator on a car that is running
• Medical treatments and diagnostic tests in which an electrical current is passed through the body,
such as TENS, electrocautery, electrolysis/thermolysis, electrodiagnostic testing, electromyography,
or nerve conduction studies
• Any externally applied device that uses an automatic lead detection alarm system (e.g., an EKG
machine)
• Wireless ECG. Wireless ECG is susceptible to RF interference, and may have an intermittent or lost
signal. If interference is present, especially during diagnostic testing, consider using a surface ECG
instead.
14

Hospital and Medical Environments
• Mechanical ventilators. During mechanical ventilation, respiration-based trending may be misleading;
therefore, the Respiratory Sensor should be programmed to Off.
• Conducted electrical current. Any medical equipment, treatment, therapy, or diagnostic test that
introduces electrical current into the patient has the potential to interfere with pulse generator function.
• External patient monitors (e.g., respiratory monitors, surface ECG monitors, hemodynamic
monitors) may interfere with the pulse generator’s impedance-based diagnostics (e.g., shock
lead impedance measurements, Respiratory Rate trend). To resolve suspected interactions with
Respiratory Sensor-based diagnostics, deactivate the pulse generator’s Respiratory Sensor by
programming it to Off.
• Medical therapies, treatments, and diagnostic tests that use conducted electrical current (e.g.,
TENS, electrocautery, electrolysis/thermolysis, electrodiagnostic testing, electromyography, or
nerve conduction studies) may interfere with or damage the pulse generator. Program the device
to Electrocautery Protection Mode prior to the treatment, and monitor device performance during
the treatment. After the treatment, verify pulse generator function ("Post-Therapy Pulse Generator
Follow Up" on page 19).
•Internaldefibrillation. Do not use internal defibrillation paddles or catheters unless the pulse generator
is disconnected from the leads because the leads may shunt energy. This could result in injury to the
patient and damage to the implanted system.
15

• External defibrillation. Itcantakeupto15secondsforsensingto recover after an external shock is
delivered. In non-emergency situations, for pacemaker dependent patients, consider programming the
pulse generator to an asynchronous pacing mode and programming the Respiratory Sensor to Off prior to
performing external cardioversion or defibrillation.
Avoid placing a pad (or paddle) directly over any subcutaneous leads.
External defibrillation or cardioversion can damage the pulse generator. To help prevent damage to the
pulse generator, consider the following:
• Avoid placing a pad (or paddle) directly over the pulse generator. Position the pads (or paddles)
as far from the pulse generator as possible.
• Position the pads (or paddles) in a posterior-anterior orientation when the device is implanted in
the right pectoral region or an anterior-apex orientation when the device is implanted in the left
pectoral region.
• Set energy output of external defibrillation equipment as low as clinically acceptable.
Following external cardioversion or defibrillation, verify pulse generator function ("Post-Therapy Pulse
Generator Follow Up" on page 19).
• Lithotripsy. Extracorporeal shock wave lithotripsy (ESWL) may cause electromagnetic interference with
or damage to the pulse generator. If ESWL is medically necessary, consider the following to minimize the
potential for encountering interaction:
• Focus the ESWL beam at least 15 cm (6 in) away from the pulse generator.
• Depending on the pacing needs of the patient, program the Brady Mode to Off or a
non-rate-responsive VVI mode.
• Program the Tachy mode to Off to prevent inappropriate shocks.
16