Boston Scientific U125 User manual

PHYSICIAN’S TECHNICAL MANUAL
VALITUDE™, VALITUDE™X4,
INTUA™,INVIVE
™
CARDIAC RESYNCHRONIZATION THERAPY
PACEMAKER
Model U125, U128, V272, V273, V172, V173
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 Information..................................................................................................................... 1
Device Description.......................................................................................................................... 1
Related Information ........................................................................................................................ 3
Indications and Usage .................................................................................................................... 4
Contraindications............................................................................................................................ 4
Warnings ........................................................................................................................................ 5
Precautions..................................................................................................................................... 7
Supplemental Precautionary Information ..................................................................................... 20
Post-Therapy Pulse Generator Follow Up .......................................................................... 20
Minimizing Pacemaker/S-ICD Interaction ........................................................................... 21
Transcutaneous Electrical Nerve Stimulation (TENS)......................................................... 23
Electrocautery and Radio Frequency (RF) Ablation............................................................ 24
Ionizing Radiation................................................................................................................ 26
Elevated Pressures ............................................................................................................. 27
Potential Adverse Events ............................................................................................................. 28
Mechanical Specifications ............................................................................................................ 31
Items Included in Package ........................................................................................................... 34
Symbols on Packaging ................................................................................................................. 34
Characteristics as Shipped........................................................................................................... 38
X-Ray Identifier............................................................................................................................. 39
Federal Communications Commission (FCC) .............................................................................. 41
Pulse Generator Longevity........................................................................................................... 42
Warranty Information .................................................................................................................... 46
Product Reliability......................................................................................................................... 46
Patient Counseling Information ....................................................................................................47
Patient Handbook................................................................................................................ 48
Lead Connections......................................................................................................................... 48

Implanting the Pulse Generator.................................................................................................... 52
Step A: Check Equipment ................................................................................................ 52
Step B: Interrogate and Check the Pulse Generator ........................................................ 52
Step C: Implant the Lead System..................................................................................... 53
Step D: Take Baseline Measurements ............................................................................. 54
Step E: Form the Implantation Pocket.............................................................................. 57
Step F: Connect the Leads to the Pulse Generator.......................................................... 58
Step G: Evaluate Lead Signals......................................................................................... 62
Step H: Program the Pulse Generator.............................................................................. 63
Step I: Implant the Pulse Generator ................................................................................. 64
Step J: Complete and Return the Implantation Form ....................................................... 65
Bidirectional Torque Wrench......................................................................................................... 66
Follow Up Testing ......................................................................................................................... 68
Predischarge Follow Up ...................................................................................................... 68
Routine Follow Up............................................................................................................... 68
Explantation.................................................................................................................................. 69

ADDITIONAL INFORMATION
For additional reference information, go to www.bostonscientific.com/ifu.
DEVICE DESCRIPTION
This manual contains information about the VALITUDE, INTUA, and INVIVE families of cardiac
resynchronization therapy pacemakers (CRT-Ps) (specific models are listed in "Mechanical Specifications"
on page 31).
NOTE: Specific features discussed in this manual may not apply to all models. References to names of
non-quadripolar devices also apply to the corresponding quadripolar devices. References to “ICD” include all
types of ICDs (e.g., ICD, CRT-D, S-ICD).
Therapies
These pulse generators provide a variety of therapies, including:
• 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
Leads
The pulse generator has independently programmable outputs and accepts one or more of the following
leads, depending on the model:
•OneIS-1
1unipolar or bipolar atrial lead
• One IS-1 unipolar or bipolar right ventricular lead
• One LV-1 unipolar or bipolar left ventricular lead
1. IS-1 refers to the international standard ISO 5841-3:2013.
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• One IS-1 unipolar or bipolar left ventricular lead
• One compatible IS42quadripolar left ventricular lead3
The pulse generator and the leads constitute the implantable portion of the pulse generator system.
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 2869 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
• Store a 12 second trace of the ECG/EGM display from any screen
• Access an interactive Demonstration Mode or Patient Data Mode without the presence of a pulse
generator
• Print patient data including pulse generator therapy options and therapy history data
2. IS4 refers to the international standard ISO 27186:2010.
3. Compatibility with St. Jude Quartet IS4 lead has been demonstrated through chronic in-vivo animal GLP testing.
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• Save patient data
You can program the pulse generator using two methods: automatically using Indications-Based Programming
(IBP) or manually.
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 or ZOOM Wireless Transmitter Reference Guide for specific
information about the PRM or ZOOM Wireless Transmitter such as setup, maintenance, and handling.
LATITUDE NXT is a remote monitoring system that provides pulse generator data for clinicians. These pulse
generators are designed to be LATITUDE NXT enabled; availability varies by region.
LATITUDE NXT is available for the following devices: VALITUDE, INTUA, INVIVE.
• Physicians/Clinicians—LATITUDE NXT enables you to periodically monitor both patient and device
status remotely and automatically. The LATITUDE NXT system provides patient data that can be used
as part of the clinical evaluation of the patient.
• Patients—A key component of the system is the LATITUDE Communicator, an easy-to-use, in-home
monitoring device. The Communicator automatically reads implanted device data from a compatible
Boston Scientific pulse generator at times scheduled by the physician. The Communicator sends this
data to the LATITUDE NXT secure server through a standard analog telephone line or over a cellular data
network. The LATITUDE NXT server displays the patient data on the LATITUDE NXT Web site, which is
readily accessible over the Internet to authorized physicians and clinicians.
Refer to the LATITUDE NXT Clinician Manual for more information.
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INTENDED AUDIENCE
This literature is intended for use by professionals trained or experienced in device implant and/or follow-up
procedures.
INDICATIONS AND USAGE
Boston Scientific cardiac resynchronization therapy pacemakers (CRT-Ps) are indicated for patients with
moderate to severe heart failure (NYHA Class III/IV) including left ventricular dysfunction (EF ≤35%) and
QRS duration ≥120 ms and remain symptomatic despite stable optimal pharmacological therapy (OPT)
for heart failure.
Atrial tracking modes are also indicated for patients who may benefit from maintenance of AV synchrony.
Adaptive-rate pacing is indicated for patients exhibiting chronotropic incompetence and who would benefitfrom
increased pacing rates concurrent with increases in physical activity.
CONTRAINDICATIONS
These Boston Scientific pulse generators have the following contraindications:
• This device is contraindicated in patients who have a separate implanted cardioverter defibrillator (ICD)
with transvenous leads.
• Unipolar pacing or use of the Respiratory Sensor with a Subcutaneous Implantable Cardioverter
Defibrillator (S-ICD) is contraindicated because it may cause inappropriate therapy or inhibition of
appropriate S-ICD therapy.
• Single-chamber atrial pacing is contraindicated in patients with impaired AV nodal conduction.
• Atrial tracking modes are contraindicated in patients with chronic refractory atrial tachyarrhythmias (atrial
fibrillation or flutter), which might trigger ventricular pacing.
• Asynchronous pacing is contraindicated in the presence (or likelihood) of competition between paced
and intrinsic rhythms.
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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.
• 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.
• Separate pulse generator. Using multiple pulse generators could cause pulse generator interaction,
resulting in patient injury or a lack of therapy delivery. Test each system individually and in combination to
help prevent undesirable interactions ("Minimizing Pacemaker/S-ICD Interaction" on page 21).
• Safety Core operation. In response to applicable nonrecoverable or repeat fault conditions, the pulse
generator will switch irreversibly to Safety Core operation. Safety Core pacing is unipolar, which may
interact with an ICD ("Minimizing Pacemaker/S-ICD Interaction" on page 21).
Handling
• 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.
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• 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 IS4–LLLL lead terminal,
other than the terminal pin, even when the lead cap is in place.
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.
• Lead Safety Switch. Lead Safety Switch should be programmed Off for patients with an ICD. Unipolar
pacing due to Lead Safety Switch is contraindicated for patients with an ICD.
• RAAT testing. Unipolar pacing due to RAAT is contraindicated and should be programmed off for patients
with an ICD. The RAAT feature performs automatic threshold testing in a unipolar pacing configuration.
• Ventricular sensing. Left ventricular lead dislodgement to a position near the atria can result in atrial
oversensing and left ventricular pacing inhibition.
• Sensitivity settings and EMI. If programmed to a fixed atrial Sensitivity value of 0.15 mV, or a fixed
sensitivity value of 2.0 mV or less in a unipolar lead configuration in any chamber, the pulse generator
may be more susceptible to electromagnetic interference. This increased susceptibility should be taken
into consideration when determining the follow-up schedule for patients requiring such a setting.
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