sorin Intensia VR 124 User manual

Implant manual
Implantable cardioverter defibrillator
VR model 124

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TABLE OF CONTENTS
1. General description................................................................................................................ 5
2. Indications............................................................................................................................... 6
3. Contraindications....................................................................................................................
4. Warnings and precautions.....................................................................................................8
4.1. Risks related to medical environment.......................................................................................9
4.2. Sterilization, storage and andling..........................................................................................10
4.3. Implantation and device programming....................................................................................10
4.4. Lead evaluation and lead connection......................................................................................11
4.5. Generator explant and disposal..............................................................................................12
5. Adverse events...................................................................................................................... 13
5.1. Defender study........................................................................................................................ 13
6. Clinical studies...................................................................................................................... 15
6.1. Defender study........................................................................................................................ 15
. Patient selection and treatment...........................................................................................18
7.1. Individualization of treatment..................................................................................................18
7.2. Specific patient populations....................................................................................................19
8. Patient counselling information..........................................................................................20
9. Conformance to standards..................................................................................................21
10. Physician guidelines.............................................................................................................24
10.1. P ysician training.................................................................................................................... 24
10.2. Directions for use....................................................................................................................24
10.3. Maintaining device quality.......................................................................................................24
11. Patient information............................................................................................................... 25
12. How supplied......................................................................................................................... 26
12.1. Sterility....................................................................................................................................26
12.2. Warranty and replacement policy............................................................................................26
13. Device description................................................................................................................ 2
14. Implant procedure................................................................................................................. 29
14.1. Necessary equipment............................................................................................................. 29
14.2. Packaging............................................................................................................................... 29
14.3. Optional equipment.................................................................................................................29
14.4. Before opening t e package...................................................................................................29
14.5. Prior to implantation................................................................................................................30
14.6. Device placement....................................................................................................................30
14.7. C oosing t e type of lead.......................................................................................................30
14.8. S ock configuration (+ -> -).....................................................................................................31
14.9. Measurement of t res olds at implant....................................................................................31
14.10.Lead connection ..................................................................................................................... 31
14.11. Device implantation................................................................................................................. 33
14.12.Tests and programming...........................................................................................................33
15. Special modes....................................................................................................................... 34
15.1. Safety mode (nominal values).................................................................................................34
15.2. Magnet mode..........................................................................................................................34
15.3. Response in t e presence of interference..............................................................................34
SORIN – INTENSIA VR 124 – U153A 3

15.4. Detection c aracteristics in t e presence of electromagnetic fields........................................35
15.5. Protection against s ort-circuits..............................................................................................35
16. Main functions....................................................................................................................... 36
16.1. Automatic lead measurements................................................................................................36
16.2. Ventricular tac yarr yt mia management...............................................................................36
16.3. Pacing.....................................................................................................................................36
16.4. Sensing...................................................................................................................................36
16.5. Follow-up function...................................................................................................................37
16.6. Remote Monitoring function....................................................................................................37
1 . Patient follow-up................................................................................................................... 40
17.1. Follow-up recommendations...................................................................................................40
17.2. Holter Function........................................................................................................................40
17.3. Recommended Replacement Time (RRT)..............................................................................41
17.4. Explantation............................................................................................................................ 41
17.5. Defibrillator identification.........................................................................................................42
18. Physical characteristics.......................................................................................................43
18.1. Materials used.........................................................................................................................43
19. Electrical characteristics......................................................................................................44
19.1. Table of delivered s ock energy and voltage..........................................................................44
19.2. Battery..................................................................................................................................... 44
19.3. Longevity.................................................................................................................................45
20. Programmable parameters...................................................................................................46
20.1. Antibradycardia pacing............................................................................................................46
20.2. Ventricular tac yarr yt mia detection.....................................................................................47
20.3. Ventricular tac yarr yt mia t erapies.....................................................................................48
20.4. Remote alerts and warnings................................................................................................... 51
21. Non programmable parameters...........................................................................................53
22. Limited warranty................................................................................................................... 54
22.1. Article 1 : Terms of limited warranty........................................................................................54
22.2. Article 2 : Terms of replacement..............................................................................................55
23. Patents................................................................................................................................... 56
24. Explanation of symbols........................................................................................................5
4SORIN – INTENSIA VR 124 – U153A

1. GENERAL DESCRIPTION
1. GENERAL DESCRIPTION
INTENSIA VR 124 is an implantable single-c amber cardioverter defibrillator. It is equipped
wit an accelerometer to allow adaptation of pacing to suit t e patient’s activity.
INTENSIA VR 124 is also equipped wit t e RF wireless tec nology w ic enables to
remotely monitor t e patients w o ave t e Sorin SMARTVIEW Monitor installed at ome.
INTENSIA VR 124 provides ig energy s ocks (42 J) for en anced safety, as well as
automatic lead measurements to monitor system integrity.
INTENSIA VR 124 is protected against ig -frequency signals emitted by cellular
telep ones.
SORIN – INTENSIA VR 124 – U153A 5

2. INDICATIONS
2. INDICATIONS
INTENSIA VR 124 is indicated for use in patients w o are at ig risk of sudden cardiac
deat due to ventricular tac yarr yt mias and w o ave experienced one of t e following
situations:
─Survival of at least one episode of cardiac arrest (manifested by t e loss of
consciousness) due to ventricular tac yarr yt mia,
─Recurrent, poorly tolerated sustained ventricular tac ycardia (VT).
NOTE: The clinical outcome for hemodynamically stable VT patients is not fully known.
Safety and effectiveness studies have not been conducted.
6SORIN – INTENSIA VR 124 – U153A

3. CONTRAINDICATIONS
3. CONTRAINDICATIONS
Implantation of INTENSIA VR 124 is contraindicated in patients:
─w ose ventricular tac yarr yt mias may ave transient or reversible causes suc as:
acute myocardial infarction, digitalis intoxication, drowning, electrocution, electrolyte
imbalance, ypoxia, sepsis, or unstable isc emic episodes,
─w o present incessant tac yarr yt mia,
─w o ave an internal pacemaker,
─w ose primary disorder is bradyarr yt mias, or atrial tac yarr yt mias.
SORIN – INTENSIA VR 124 – U153A 7

4. WARNINGS AND PRECAUTIONS
4. WARNINGS AND PRECAUTIONS
T e patient s ould be warned of t e potential risks of defibrillator malfunction if e is
exposed to external magnetic, electrical, or electromagnetic signals.
T ese potential interference sources may cause conversion to in ibited mode (because of
noise detection), erratic delivery of VT or VF t erapies, nominal programming, or muc more
rarely, irreversible damage to t e device’s circuits.
T e main sources of ig magnitude electromagnetic interference (EMI) are: powerful
radiofrequency equipment (radar), industrial motors and transformers, induction furnaces,
resistance, arc-welding equipment and ig power loudspeakers.
Resuscitation Availability:
Do not perform device testing unless an external defibrillator and medical personnel skilled
in cardiopulmonary resuscitation (CPR) are readily available.
Electrical Isolation:
Do not permit t e patient to contact grounded equipment t at could produce azardous
leakage current. Ensuing arr yt mia induction could result in t e patient’s deat .
Disable the ICD During Handling:
Program S ock T erapy to OFF during surgical implant and explant or post mortem
procedures. T e device can deliver a serious ig energy s ock s ould accidental contact
be made wit t e defibrillation electrodes.
Antitheft gates:
Since antit eft devices at t e entrance to stores are not subject to any safety standards, it is
advisable to spend as little time as possible in t eir vicinity.
Airport detection systems:
Since airport detection systems are not subject to any safety standards, it is advisable to
spend as little time as possible in t eir vicinity.
High voltage power transmission lines:
Hig voltage power transmission lines may generate enoug EMI to interfere wit
defibrillator operation if approac ed too closely.
Communication equipment:
Communication equipment suc as microwave transmitters, linear power amplifiers, or ig -
power amateur transmitters may generate enoug EMI to interfere wit defibrillator
operation if approac ed too closely.
Home appliances:
Home appliances t at are in good working order and properly grounded do not usually
produce enoug EMI to interfere wit defibrillator operation. T ere are reports of device
disturbances caused by electric and tools or electric razors used directly over t e device
implant site.
8SORIN – INTENSIA VR 124 – U153A

4. WARNINGS AND PRECAUTIONS
4.1. RISKS RELATED TO MEDICAL ENVIRONMENT
It is advisable to carefully monitor defibrillator operation prior to and after any medical
treatment during w ic an electrical current from an external source passes t roug t e
patient's body.
Magnetic Resonance Imaging:
MRI is strictly contraindicated in cardiac defibrillator patients.
Radiofrequency ablation:
A radiofrequency ablation procedure in a patient wit a generator may cause device
malfunction or damage. RF ablation risks may be minimized by:
1. Programming S ock T erapy and ATP to OFF.
2. Avoiding direct contact between t e ablation cat eter and t e implanted lead or generator.
3. Positioning t e ground, placing it so t at t e current pat way does not pass t roug or
near t e device, i.e. place t e ground plate under t e patient’s buttocks or legs.
4. Having external defibrillation equipment available.
Electrocautery or diathermy device:
Diat ermy and electrocautery equipment s ould not be used. If suc devices must be used:
1. Keep t e current pat and ground plate as far away from t e device and t e lead as
possible (a minimum of 15 cm [six inc es]).
2. Before procedure, disable ATP and s ock t erapies.
3. During t e procedure, keep t e electrocautery device as far as possible from t e cardiac
defibrillator. Set it at minimum intensity. Use it briefly.
4. After t e procedure, c eck for proper implant function. T e device s ould never be
exposed directly to t e diat ermy source.
External defibrillation:
INTENSIA VR 124 is protected from external defibrillation s ocks.
1. Before external defibrillation, disable ATP and s ock t erapies.
2. During external defibrillation, it is advisable to avoid placing t e defibrillating paddles
directly over t e casing or over t e lead. T e defibrillating paddles s ould preferably be
placed in an anteroposterior position.
3. Avoid any direct contact between t e defibrillation paddles and t e conductive parts of t e
implanted leads or casing of t e implanted device.
4. After external defibrillation, c eck for proper device function.
Radiation therapy:
Avoid exposure to ionizing radiation. Betatrons are contraindicated. If ig doses of radiation
t erapy cannot be avoided, t e defibrillator s ould be protected from direct exposure wit a
protection s ield. ATP and s ock t erapies s ould be disabled during exposure and proper
device function s ould be c ecked regularly afterwards. Resulting damage may not be
SORIN – INTENSIA VR 124 – U153A 9
CAUTION: Do not tap s arply on t e ICD can after implant, because t e ICD's sensing
circuits can detect t is as R-waves, and suc oversensing could result in inappropriate
pacing, in ibition, or t erapy. Normal activities after implant do not result in suc
oversensing.

4. WARNINGS AND PRECAUTIONS
immediately detectable. If irradiation of tissues close to t e implantation site is necessary, it
is recommended t at t e cardiac defibrillator be moved. As a safety measure, an external
defibrillator s ould be immediately available.
Lithotripsy:
Lit otripsy may permanently damage t e device if it is at t e focal point of t e lit otripsy
beam. If lit otripsy must be used, keep t e defibrillator at least 2.5 to 5 cm (1-2 inc es) away
from t e focal point of t e lit otripsy beam.
Diagnostic ultrasound (echography):
T e defibrillator is not affected by ultrasound imaging devices.
Scales with body fat monitors and electronic muscle stimulators:
A patient wit an implanted INTENSIA VR 124 s ould not use t ese devices.
4.2. STERILIZATION, STORAGE AND HANDLING
Resterilization:
Do not resterilize and re-implant explanted ICDs.
"Use Before" Date:
A "Use Before" date is printed on t e outer storage package and on t e sterile package. Do
not implant t e device after t is date because t e battery may ave reduced longevity and
sterility may be affected. It s ould be returned to Sorin.
If Package is damaged:
Do not use t e device or accessories if t e packaging is wet, punctured, opened or
damaged because t e integrity of t e sterile packaging may be compromised. Return t e
device to t e manufacturer.
Device Storage:
Store t e device in a clean area, away from magnets, kits containing magnets, and sources
of electromagnetic interference to avoid device damage. Store t e device between 0 - 50 °C
(32 - 122 °F). Temperatures outside t e specified range may damage t e device.
Equilibration:
Allow t e device to reac room temperature before programming or implanting t e device
because rapid temperature c anges may affect initial device function.
4.3. IMPLANTATION AND DEVICE PROGRAMMING
Use only a Sorin programmer to communicate wit t e device.
Do not inadvertently position any magnet over t e ICD; t is suspends tac yarr yt mia
detection and treatment.
Replace t e device w en t e RRT (Recommended Replacement Time*) point (defined by a
battery voltage of 2.66 ± 0.01 V or a magnet rate lower t an or equal to 80 bpm) is reac ed.
Program device parameters suc as sensitivity t res old and VT and VF detection intervals
as specified in t e device manuals.
Lead System:
Do not use a lead system ot er t an t ose wit demonstrated compatibility because
undersensing cardiac activity and failure to deliver necessary t erapy may result.
10 SORIN – INTENSIA VR 124 – U153A

4. WARNINGS AND PRECAUTIONS
In situations w ere an ICD and a pacemaker are implanted in t e same patient, interaction
testing s ould be completed. If t e interaction between t e ICD and t e pacemaker cannot
be resolved t roug repositioning of t e leads or reprogramming of eit er t e pacemaker or
t e ICD, t e pacemaker s ould not be implanted (or s ould be explanted if previously
implanted).
Failure to properly insert t e torque screwdriver into t e perforation at an angle
perpendicular to t e connector receptacle may result in damage to t e sealing system and
its self-sealing properties.
It is recommended t at a security margin of at least 10 J be demonstrated between t e
effective s ock energy and maximum programmable energy. Carefully confirm t at true
ventricular fibrillation as been induced because t e DFT for ventricular tac ycardia or flutter
may be lower.
T e defibrillator s ould be implanted wit t e engraved side facing outwards in order to
facilitate telemetric communication wit t e programming ead and to display t e
radiograp ic identification correctly.
*: corresponds to ERI (Elective Replacement Indicator) previously used.
4.4. LEAD EVALUATION AND LEAD CONNECTION
INTENSIA VR 124 as one DF-4 connector port.
DF-4 refers to t e international standard for defibrillation lead connectors (ISO 27186:2010).
Do not use t e device wit leads w ic ave not been positively tested.
Do not tie a ligature directly to t e lead body, tie it too tig tly, or ot erwise create excessive
strain at t e insertion site as t is may damage t e lead. Use t e lead stabilizer to secure t e
lead lateral to t e venous entry site.
Do not immerse t e lead in mineral oil, silicone oil, or any ot er liquid.
Do not grip t e lead wit surgical instruments.
Do not use excessive force or surgical instruments to insert a stylet into a lead.
Use ventricular transvenous leads wit caution in patients wit eit er a mec anical or
bioprost etic tricuspid valvular prost esis.
Use t e correct suture sleeve (w en needed) , to immobilize t e lead and protect it against
damage from ligatures.
Never implant t e system wit a lead system t at as a measured s ock impedance of less
t an 30 o ms. A protection circuit in t e defibrillator prevents s ock delivery w en
impedance is too low. If t e s ock impedance is less t an 30 o ms, reposition t e lead
system to allow a greater distance between t e electrodes.
Do not kink leads. Kinking leads may cause additional stress on t e leads, possibly resulting
in lead fracture.
Do not insert a lead connector pin into t e connector block wit out first visually verifying t at
t e setscrews are sufficiently retracted. Do not tig ten t e setscrews unless a lead
connector pin is inserted because it could damage t e connector block.
Lead electrodes in contact during a cardioversion or defibrillation t erapy will cause current
to bypass t e eart, possibly damaging t e ICD and t e lead. W ile t e ICD is connected
to t e lead, make sure t at t e metal portions of any electrodes do not touc eac ot er.
If a pacing lead is abandoned rat er t an removed, it must be capped to ensure t at it is not
a pat way for currents to or from t e eart.
If a t oracotomy is required to place epicardial patc es, it s ould be done during a separate
procedure to reduce t e risk of morbidity and mortality.
SORIN – INTENSIA VR 124 – U153A 11

4. WARNINGS AND PRECAUTIONS
Do not place t e patc lead over nerve tissue as t is may cause nerve damage.
Place t e patc lead wit t e conducting coil side facing t e eart to ensure delivery of
energy to t e eart.
Place t e sutures well outside t e coil of t e patc lead or in t e area between t e coils to
avoid possible coil fracture.
If counters ock is unsuccessful using external paddles, adjust t e external paddle position
(e.g., anterior-lateral to anterior-posterior) and be sure t at t e external paddle is not
positioned over t e patc .
Do not fold, alter, or remove any portion of t e patc as it may compromise electrode
function or longevity.
If a eader port is unused on t e generator, t e port must be plugged to protect t e
generator.
4.5. GENERATOR EXPLANT AND DISPOSAL
Interrogate t e device, and program s ock t erapy off prior to explanting, cleaning or
s ipping t e device to prevent unwanted s ocks.
Return all explanted generators and leads to t e manufacturer.
Never incinerate t e device due to t e potential for explosion. T e device must be explanted
before cremation.
12 SORIN – INTENSIA VR 124 – U153A

5. ADVERSE EVENTS
5. ADVERSE EVENTS
Clinical data presented in t is section are from t e Defender study. INTENSIA VR 124 is
similar in design and function to t e Defender devices. T e data provided are applicable to
INTENSIA VR 124.
5.1. DEFENDER STUDY
Clinical study of Defender IV DR 612 included 60 devices implanted in 60 patients, 38 in
Europe (37 patients followed for a minimum of 3 mont s), and 22 in t e U.S. (IDE
G970282/S15) wit a total device exposure of 228.7 and 30.3 device mont s, respectively.
No deat s, serious adverse experiences or complications were judged to be device-related,
as determined by t e investigator. T e following tables summarize t e safety data for t is
study.
T ere was 1 deat in t e study t at was classified as arr yt mic. T e cause of deat was
recurrent VT/VF w ic occurred 19 days post implant.
In t e following tables, complications are defined as adverse device effect, w ic cannot be
treated or resolved by simple adjustments (e.g. reprogramming) and requires intervention.
NOTE: The company classified as complications those adverse device effects that were
treated with surgery or with e ternal defibrillation of a ventricular cardiac event.
Observations are defined as symptomatic or asymptomatic clinical events wit potential
adverse device effects t at do not require intervention or can be corrected by simple
adjustments.
NOTE: The company classified as observations those adverse device effects that were
treated with programming changes, medication, or other method that was not classified as a
complication.
Two of t e 38 Defender IV DR 612 patients in Europe (37 patients followed for a minimum of
3 mont s) experienced a total of t ree complications, including device failures and
replacements. Fourteen of t e 38 Defender IV DR 612 patients experienced a total of 18
observations. Complications and observations are reported in Tables 1 and 2. It s ould be
noted t at a patient can ave more t an one observation or complication. T ere were no
observations or complications in t e U.S.
Table 1: Summary of European Clinical Complications
(Including Device Failures and Replacements)
All complications, 2 of 38 Defender IV DR 612 patients in Europe
Event # of Patients % of Patients # of Events Events/100
Device-Years*
Hematoma 1 2.6 1 5.2
Ventricular lead
migration/dislodgment
2 5.3 2 10.5
* T ere were 228.7 device mont s in t is study.
Table 2: Summary of European Clinical Complications
(Including Patient Complaints)
All complications, 14 of 38 Defender IV DR 612 patients in Europe
SORIN – INTENSIA VR 124 – U153A 13

5. ADVERSE EVENTS
Event # of Patients* % of Patients # of Events Events/100
Device-
Years**
C ange in ventricular sensing
t res old
1 2.6 1° 5.2
Device reset*** 1 2.6 1° 5.2
Inappropriate t erapy for EMI 1 2.6 1° 5.2
Pneumot orax 1 2.6 1° 5.2
Pocket ematoma 2 5.3 2° 10.5
Pocket infection/ ematoma 1 2.6 1° 5.2
Pocket infection from previous
pacemaker
1 2.6 1° 5.2
Prolonged implant procedure 1 2.6 1 5.2
Sensor acceleration during
telemetry***
1 2.6 1 5.2
S ock for VT in VF Zone 1 2.6 1° 5.2
Slow VT not converted by ATP
t erapy
1 2.6 2° 10.5
Unsatisfactory sensing
t res old test***
2 5.3 2 10.5
Ventricular oversensing 3 7.9 3 15.7
* A patient can ave more t an one observation.
** T ere were 228.7 device mont s in t is study.
***T ese observations would not ave appened wit t e currently marketed device and
programmer.
°Investigator indicated t at Defender IV DR did not cause or contribute to t e event.
14 SORIN – INTENSIA VR 124 – U153A

6. CLINICAL STUDIES
6. CLINICAL STUDIES
Clinical data presented in t is section are from t e Defender study. INTENSIA VR 124 is
similar in design and function to t e Defender devices. T e data provided are applicable to
INTENSIA VR 124.
6.1. DEFENDER STUDY
Objectives:
T e primary objectives of t is study were to demonstrate a complication free rate (CFR)
comparable to t at of istorical controls, to demonstrate, using a c ronotropic assessment
exercise protocol (CAEP), a rate response proportional to and appropriate for t e level of
exercise, and to evaluate and report t e incidence of adverse events.
Materials:
Eac patient received one Defender IV DR 612 defibrillator, an atrial pacing and sensing
lead, and a Medtronic, Angeion, or Biotronik defibrillation lead in t e U.S. or any
commercially available defibrillator lead outside t e U.S.
Methods:
Investigators selected patients w o survived at least one episode of cardiac arrest
(manifested by loss of consciousness) presumably due to a ventricular tac yarr yt mia or
ex ibited recurrent, poorly tolerated, sustained ventricular tac ycardia (VT). T e protocol
required evaluation of performance and adverse events at pre-disc arge, one mont , t ree
mont s, six mont s, and (in t e U.S.) every t ree mont s t ereafter. At t e one-mont visit,
eligible patients performed a c ronotropic assessment exercise protocol (CAEP) maximal
exercise test.
Study Population.
T e table below summarizes inclusions.
Region Date of first
implant
Date of last
implant
Data cut-off
date
Number of
centers
Number of
patients
US 14-Dec-99 08-Mar-00 14-Mar-00 6 22
Europe 04-May-99 26-Jul-99 14-Apr-00 11 38
All 04-May-99 08-Mar-00 14-Apr-00 (Eur),
14-Mar-00 (US)
17 60
6.1.1 . Complication-free rate
Only European patients followed for at least 3 mont s:
Symbol Parameter Defender IV DR 612
N Overall number of patients 37
Pe*N Number of successes 35
SORIN – INTENSIA VR 124 – U153A 15

6. CLINICAL STUDIES
Pe Observed experimental
proportion
0.95
Ps Null ypot esis success rate 0.76
ES Estimated standard error of Pe 0.04
z´ Test statistic (1) 4.75
p Associated p-value < 0,0001
(1) Statistical test: z´ = (Pe-Ps)/SE w ere SE = sqrt(Pe(1-Pe)/N)
6.1.2 . Rate response
European patients only:
GROUP Number of
patients
included
Mean slope
%SRR on
%MR
STD of
slopes
%SRR on
%MR
SE of mean
slope %SRR
on %MR
Lower 95%
CI
Upper 95%
CI
Europe 20 0.77 0.17 0.04 0.69 0.84
Small
Centers
9 0.79 0.18 0.06 0.67 0.91
Large
Centers
11 0.75 0.15 0.05 0.66 0.84
Males 17 0.77 0.16 0.04 0.70 0.85
Females 3 0.73 0.22 0.13 0.47 0.98
SRR: Sensor Rate Reserve
MR: Metabolic Reserve
STD: Standard Deviation
SE: Standard Error
CI: Confidence Interval
6.1.3 . Adverse events
Event US (N=22) Number of events* Number of patients Percent of patients
Intent to treat but did
not
0 0 0.0
Non-device related
deat
0 0 0.0
Explant 0 0 0.0
Complication 0 0 0.0
Observation 0 0 0.0
Serious non-related
ot er t an deat
1 1 4.5
16 SORIN – INTENSIA VR 124 – U153A

6. CLINICAL STUDIES
Event Europe (N=38) Number of events* Number of patients Percent of patients
Intent to treat but did
not
0 0 0.0
Non-device related
deat
1 1 2.6
Explant 1 1 2.6
Complication 3 2 5.3
Observation 18 14 36.8
Serious non-related
ot er t an deat
12 7 18.4
Event All (N=60) Number of events* Number of patients Percent of patients
Intent to treat but did
not
0 0 0.0
Non-device related
deat
1 1 1.7
Explant 1 1 1.7
Complication 3 2 3.3
Observation 18 14 23.3
Serious non-related
ot er t an deat
13 8 13.3
* A patient can ave more t an one complication, observation, or serious adverse event, not
device-related.
Device Failures and Replacements:
No device failures or replacements occurred wit Defender IV DR 612 during t e study.
SORIN – INTENSIA VR 124 – U153A 17

7. PATIENT SELECTION AND TREATMENT
. PATIENT SELECTION AND TREATMENT
.1. INDIVIDUALIZATION OF TREATMENT
Exercise stress testing:
If t e patient’s condition permits, use exercise stress testing to:
─Determine t e maximum rate of t e patient’s normal r yt m,
─Identify any supraventricular tac yarr yt mias,
─Identify exercise-induced tac yarr yt mias.
T e maximum exercise rate or t e presence of supraventricular tac yarr yt mias may
influence selection of programmable parameters. Holter monitoring or ot er extended ECG
monitoring also may be elpful.
Electrophysiologic (EP) testing:
EP testing may be useful for ICD candidates.
EP testing may identify t e classifications and rates of all t e ventricular and atrial
arr yt mias, w et er spontaneous or during EP testing.
Drug resistant supraventricular tachyarrhythmias (SVTs):
Drug resistant supraventricular tac yarr yt mias (SVTs) may initiate frequent unwanted
device t erapy.
A careful c oice of programming options is necessary for suc patients.
Antiarrhythmic drug therapy:
If t e patient is being treated wit antiarr yt mic or cardiac drugs, t e patient s ould be on a
maintenance drug dose rat er t an a loading dose at t e time of ICD implantation. If
c anges to drug t erapy are made, repeated arr yt mia inductions are recommended to
verify ICD detection and conversion. T e ICD also may need to be reprogrammed.
C anges in a patient’s antiarr yt mic drug or any ot er medication t at affects t e patient’s
normal cardiac rate or conduction can affect t e rate of tac yarr yt mias and/or efficacy of
t erapy.
Direct any questions regarding t e individualization of patient t erapy to Sorin’s
representative.
18 SORIN – INTENSIA VR 124 – U153A
CAUTION: To avoid inappropriate t erapy during an exercise stress test, do not reprogram
any parameter during t e test. W en a parameter is reprogrammed, "Discrimination"
algorit m forces acceleration to "ventricular". During conducted sinus tac ycardia wit in t e
programmed Tac y zone, t e device detects a 1:1 fast r yt m. Assuming t at acceleration
was set to ventricular by reprogramming, t e device may identify t is as a VT, and may
immediately apply t e corresponding t erapy.