sorin Platinum VR 1210 User manual

Implantable cardioverter defibrillator
VR models
Implant manual

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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 handling..........................................................................................10
4.3. Implantation and device programming....................................................................................10
4.4. Lead eval ation and lead connection......................................................................................11
4.5. Generator explant and disposal..............................................................................................12
5. Adverse events...................................................................................................................... 13
5.1. Defender st dy........................................................................................................................ 13
6. Clinical studies......................................................................................................................15
6.1. Defender st dy........................................................................................................................ 15
. Patient selection and treatment...........................................................................................18
7.1. Individ alization of treatment..................................................................................................18
7.2. Specific patient pop lations....................................................................................................19
8. Patient counselling information..........................................................................................20
9. Declaration of conformity.....................................................................................................21
10. Physician guidelines.............................................................................................................23
10.1. Physician training....................................................................................................................23
10.2. Directions for se.................................................................................................................... 23
10.3. Maintaining device q ality.......................................................................................................23
11. Patient information...............................................................................................................24
12. How supplied.........................................................................................................................25
12.1. Sterility.................................................................................................................................... 25
12.2. Warranty and replacement policy............................................................................................25
13. Device description................................................................................................................26
14. Implant procedure.................................................................................................................28
14.1. Necessary eq ipment............................................................................................................. 28
14.2. Packaging...............................................................................................................................28
14.3. Optional eq ipment.................................................................................................................28
14.4. Before opening the package...................................................................................................29
14.5. Prior to implantation................................................................................................................ 29
14.6. Device placement.................................................................................................................... 29
14.7. Choosing the type of lead.......................................................................................................29
14.8. Shock config ration (+ -> -).....................................................................................................30
14.9. Meas rement of thresholds at implant....................................................................................30
14.10.Lead connection .....................................................................................................................31
14.11. Device implantation.................................................................................................................32
14.12.Tests and programming...........................................................................................................32
15. Special modes....................................................................................................................... 34
15.1. Safety mode (nominal val es).................................................................................................34
15.2. Magnet mode.......................................................................................................................... 34
15.3. Response in the presence of dist rbance...............................................................................34
SORIN – PLATINIUM VR – U461A 3

15.4. Detection characteristics in the presence of electromagnetic fields........................................34
15.5. Protection against short-circ its..............................................................................................35
16. Main functions.......................................................................................................................36
16.1. A tomatic lead meas rements................................................................................................36
16.2. Ventric lar tachyarrhythmia management...............................................................................36
16.3. Pacing..................................................................................................................................... 37
16.4. Sensing................................................................................................................................... 37
16.5. Follow- p f nction...................................................................................................................37
16.6. Remote Monitoring f nction....................................................................................................37
1 . Patient follow-up................................................................................................................... 40
17.1. Follow- p recommendations...................................................................................................40
17.2. Holter F nction........................................................................................................................ 40
17.3. Recommended Replacement Time (RRT)..............................................................................41
17.4. Explantation............................................................................................................................41
17.5. Defibrillator identification.........................................................................................................42
18. Physical characteristics....................................................................................................... 43
18.1. Materials sed......................................................................................................................... 43
19. Electrical characteristics......................................................................................................44
19.1. Table of delivered shock energy and voltage..........................................................................44
19.2. Battery.....................................................................................................................................44
19.3. Longevity.................................................................................................................................45
20. Programmable parameters...................................................................................................4
20.1. Antibradycardia pacing............................................................................................................47
20.2. Ventric lar tachyarrhythmia detection.....................................................................................49
20.3. Ventric lar tachyarrhythmia therapies.....................................................................................50
20.4. Remote alerts and warnings...................................................................................................53
21. Non programmable parameters...........................................................................................55
22. Limited warranty...................................................................................................................56
23. Patents................................................................................................................................... 5
24. Explanation of symbols........................................................................................................58
4SORIN – PLATINIUM VR – U461A

1. GENERAL DESCRIPTION
1. GENERAL DESCRIPTION
PLATINIUM VR is an implantable single-chamber cardioverter defibrillator. It is eq ipped
with an accelerometer to allow adaptation of pacing to s it the patient’s activity.
PLATINIUM VR is also eq ipped with the RF wireless technology which enables:
─Remote monitoring of patients who have the Sorin SMARTVIEW Monitor installed at
home,
─wireless interrogation and device programming by Orchestra Pl s programmer eq ipped
with ORCHESTRA PLUS LINK accessory.
PLATINIUM VR provides high energy shocks (42 J) for enhanced safety, as well as
a tomatic lead meas rements to monitor system integrity.
PLATINIUM VR is protected against high-freq ency signals emitted by cell lar telephones.
Device and lead connections:
PLATINIUM VR 1210 1*IS-1 bipolar, 2*DF-1
PLATINIUM VR 1240 1*DF4
SORIN – PLATINIUM VR – U461A 5

2. INDICATIONS
2. INDICATIONS
PLATINIUM VR is indicated for se in patients who are at high risk of s dden cardiac death
d e to ventric lar tachyarrhythmias and who have experienced one of the following
sit ations:
─S rvival of at least one episode of cardiac arrest (manifested by the loss of
conscio sness) d e to ventric lar tachyarrhythmia,
─Rec rrent, poorly tolerated s stained ventric lar tachycardia (VT).
6SORIN – PLATINIUM VR – U461A
NOTE: The clinical o tcome for hemodynamically stable VT patients is not f lly known.
Safety and effectiveness st dies have not been cond cted.

3. CONTRAINDICATIONS
3. CONTRAINDICATIONS
Implantation of PLATINIUM VR is contraindicated in patients:
─whose ventric lar tachyarrhythmias may have transient or reversible ca ses s ch as:
ac te myocardial infarction, digitalis intoxication, drowning, electroc tion, electrolyte
imbalance, hypoxia, sepsis, or nstable ischemic episodes,
─who present incessant tachyarrhythmia,
─who have an internal pacemaker,
─whose primary disorder is bradyarrhythmias, or atrial tachyarrhythmias.
SORIN – PLATINIUM VR – U461A 7

4. WARNINGS AND PRECAUTIONS
4. WARNINGS AND PRECAUTIONS
The patient sho ld be warned of the potential risks of defibrillator malf nction if he is
exposed to external magnetic, electrical, or electromagnetic signals.
These potential interference so rces may ca se conversion to inhibited mode (beca se of
noise detection), erratic delivery of VT or VF therapies, nominal programming, or m ch more
rarely, irreversible damage to the device’s circ its.
The main so rces of high magnit de dist rbance are: powerf l radiofreq ency eq ipment
(radar), ind strial motors and transformers, ind ction f rnaces, resistance, arc-welding
eq ipment and high power lo dspeakers.
Electrical Isolation:
Do not permit the patient to contact gro nded eq ipment that co ld prod ce hazardo s
leakage c rrent. Ens ing arrhythmia ind ction co ld res lt in the patient’s death.
Antitheft gates:
Since antitheft devices at the entrance to stores are not s bject to any safety standards, it is
advisable to spend as little time as possible in their vicinity.
Airport detection systems:
Since airport detection systems are not s bject to any safety standards, it is advisable to
spend as little time as possible in their vicinity.
Work environment:
The patient's work environment may be an important so rce of dist rbance. In that case,
specific recommendations may be req ired.
High voltage power transmission lines:
High voltage power transmission lines may generate eno gh dist rbance to interfere with
defibrillator operation if approached too closely.
Communication equipment:
Comm nication eq ipment s ch as microwave transmitters, linear power amplifiers, or high-
power amate r transmitters may generate eno gh dist rbance to interfere with defibrillator
operation if approached too closely.
Home appliances:
Home appliances that are in good working order and properly gro nded do not s ally
prod ce eno gh dist rbance to interfere with defibrillator operation. However, there are
reports of device interferences ca sed by electric hand tools or electric razors sed directly
over the device implant site. Patient sho ld also avoid sing ind ction ovens and cookers.
8SORIN – PLATINIUM VR – U461A
CAUTION: Do not tap sharply on the ICD can after implant, beca se the ICD's sensing
circ its can detect this as R-waves, and s ch oversensing co ld res lt in inappropriate
pacing, inhibition, or therapy. Normal activities after implant do not res lt in s ch
oversensing.

4. WARNINGS AND PRECAUTIONS
4.1. RISKS RELATED TO MEDICAL ENVIRONMENT
It is advisable to caref lly monitor defibrillator operation prior to and after any medical
treatment d ring which an electrical c rrent from an external so rce passes thro gh the
patient's body.
Magnetic Resonance Imaging:
MRI is strictly contraindicated in cardiac defibrillator patients.
Radiofrequency ablation:
A radiofreq ency ablation proced re in a patient with a generator may ca se device
malf nction or damage. RF ablation risks may be minimized by:
1. Programming Shock Therapy and ATP to OFF.
2. Avoiding direct contact between the ablation catheter and the implanted lead or generator.
3. Positioning the gro nd, placing it so that the c rrent pathway does not pass thro gh or
near the device, i.e. place the gro nd plate nder the patient’s b ttocks or legs.
4. Having external defibrillation eq ipment available.
Electrocautery or diathermy device:
Diathermy and electroca tery eq ipment sho ld not be sed. If s ch devices m st be sed:
1. Keep the c rrent path and gro nd plate as far away from the device and the lead as
possible (a minim m of 15 cm [six inches]).
2. Before proced re, deactivate ATP and shock therapies.
3. D ring the proced re, keep the electroca tery device as far as possible from the cardiac
defibrillator. Set it at minim m intensity. Use it briefly.
4. After the proced re, check for proper implant f nction. The device sho ld never be
exposed directly to the diathermy so rce.
External defibrillation:
PLATINIUM VR is protected from external defibrillation shocks.
1. Before external defibrillation, deactivate ATP and shock therapies.
2. D ring external defibrillation, it is advisable to avoid placing the defibrillating paddles
directly over the casing or over the lead. The defibrillating paddles sho ld preferably be
placed in an anteroposterior position.
3. Avoid any direct contact between the defibrillation paddles and the cond ctive parts of the
implanted leads or casing of the implanted device.
4. After external defibrillation, check for proper device f nction.
Radiation therapy:
Avoid expos re to ionizing radiation. Betatrons are contraindicated. If high doses of radiation
therapy cannot be avoided, the defibrillator sho ld be protected from direct expos re with a
protection shield. ATP and shock therapies sho ld be disabled d ring expos re and proper
device f nction sho ld be checked reg larly afterwards. Res lting damage may not be
immediately detectable. If irradiation of tiss es close to the implantation site is necessary, it
is recommended that the cardiac defibrillator be moved. As a safety meas re, an external
defibrillator sho ld be immediately available.
Lithotripsy:
Lithotripsy may permanently damage the device if it is at the focal point of the lithotripsy
beam. If lithotripsy m st be sed, keep the defibrillator at least 2.5 to 5 cm (1-2 inches) away
from the focal point of the lithotripsy beam.
SORIN – PLATINIUM VR – U461A 9

4. WARNINGS AND PRECAUTIONS
Diagnostic ultrasound (echography):
The defibrillator is not affected by ltraso nd imaging devices.
Scales with body fat monitors and electronic muscle stimulators:
A patient with an implanted PLATINIUM VR sho ld not se these 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 the o ter storage package and on the sterile package. Do
not implant the device after this date beca se the battery may have red ced longevity and
sterility may be affected. It sho ld be ret rned to Sorin.
If Package is damaged:
Do not se the device or accessories if the packaging is wet, p nct red, opened or
damaged beca se the integrity of the sterile packaging may be compromised. Ret rn the
device to the man fact rer.
Device Storage:
Store the device in a clean area, away from magnets, kits containing magnets, and so rces
of electromagnetic dist rbance to avoid device damage. Store the device between 0 - 50 °C
(32 - 122 °F). Temperat res o tside the specified range may damage the device.
Equilibration:
Allow the device to reach room temperat re before programming or implanting the device
beca se rapid temperat re changes may affect initial device f nction.
4.3. IMPLANTATION AND DEVICE PROGRAMMING
Use only a Sorin programmer to comm nicate with the device.
Do not inadvertently position any magnet over the ICD; this s spends tachyarrhythmia
detection and treatment.
Replace the device when the RRT (Recommended Replacement Time*) point (defined by a
battery voltage of 2.66 ± 0.01 V or a magnet rate lower than or eq al to 80 bpm) is reached.
Program device parameters s ch as sensitivity threshold and VT and VF detection intervals
as specified in the device man als.
Lead System:
Do not se a lead system other than those with demonstrated compatibility beca se
ndersensing cardiac activity and fail re to deliver necessary therapy may res lt.
In sit ations where an ICD and a pacemaker are implanted in the same patient, interaction
testing sho ld be completed. If the interaction between the ICD and the pacemaker cannot
be resolved thro gh repositioning of the leads or reprogramming of either the pacemaker or
the ICD, the pacemaker sho ld not be implanted (or sho ld be explanted if previo sly
implanted).
Fail re to properly insert the torq e screwdriver into the perforation at an angle
perpendic lar to the connector receptacle may res lt in damage to the sealing system and
its self-sealing properties.
10 SORIN – PLATINIUM VR – U461A

4. WARNINGS AND PRECAUTIONS
In the event of a warning on a low shock impedance, and after lead replacement or
reconnection: it is recommended to check the system integrity (sensing and pacing
thresholds and the impedance of the shock electrodes)
It is recommended that a sec rity margin of at least 10 J be demonstrated between the
effective shock energy and maxim m programmable energy. Caref lly confirm that tr e
ventric lar fibrillation has been ind ced beca se the DFT for ventric lar tachycardia or fl tter
may be lower.
The defibrillator sho ld be implanted with the engraved side facing o twards in order to
facilitate telemetric comm nication with the programming head and to display the
radiographic identification correctly.
*: corresponds to ERI (Elective Replacement Indicator) previo sly sed.
4.4. LEAD EVALUATION AND LEAD CONNECTION
PLATINIUM VR 1210 has two DF-1 and one IS-1 connector ports.
PLATINIUM VR 1240 has one DF4 connector port.
IS-1 refers to the international standard whereby leads and generators from different
man fact rers are ass red a basic fit (ISO 5841-1:2000).
DF-1 refers to the international standard for defibrillation lead connectors (ISO 11318:2002).
DF4 refers to the international standard for defibrillation lead connectors (ISO 27186:2010).
Use only DF4-LLHH or DF4-LLHO standard lead connector types according to ISO 27186:
2010.
Do not tie a ligat re directly to the lead body, tie it too tightly, or otherwise create excessive
strain at the insertion site as this may damage the lead. Use the lead stabilizer to sec re the
lead lateral to the veno s entry site.
Do not immerse the lead in mineral oil, silicone oil, or any other liq id.
Do not grip the lead with s rgical instr ments.
Do not se excessive force or s rgical instr ments to insert a stylet into a lead.
Use ventric lar transveno s leads with ca tion in patients with either a mechanical or
bioprosthetic tric spid valv lar prosthesis.
Use the correct s t re sleeve (when needed), to immobilize the lead and protect it against
damage from ligat res.
Never implant the system with a lead system that has a meas red shock impedance of less
than 30 ohms. A protection circ it in the defibrillator prevents shock delivery when
impedance is too low. If the shock impedance is less than 30 ohms, reposition the lead
system to allow a greater distance between the electrodes.
Do not kink leads. Kinking leads may ca se additional stress on the leads, possibly res lting
in lead fract re.
Do not insert a lead connector pin into the connector block witho t first vis ally verifying that
the setscrews are s fficiently retracted. Do not tighten the setscrews nless a lead
connector pin is inserted beca se it co ld damage the connector block.
Lead electrodes in contact d ring a cardioversion or defibrillation therapy will ca se c rrent
to bypass the heart, possibly damaging the ICD and the lead. While the ICD is connected to
the lead, make s re that the metal portions of any electrodes do not to ch each other.
If a pacing lead is abandoned rather than removed, it m st be capped to ens re that it is not
a pathway for c rrents to or from the heart.
If a thoracotomy is req ired to place epicardial patches, it sho ld be done d ring a separate
proced re to red ce the risk of morbidity and mortality.
SORIN – PLATINIUM VR – U461A 11

4. WARNINGS AND PRECAUTIONS
Do not place the patch lead over nerve tiss e as this may ca se nerve damage.
Place the patch lead with the cond cting coil side facing the heart to ens re delivery of
energy to the heart.
Place the s t res well o tside the coil of the patch lead or in the area between the coils to
avoid possible coil fract re.
If co ntershock is ns ccessf l sing external paddles, adj st the external paddle position
(e.g., anterior-lateral to anterior-posterior) and be s re that the external paddle is not
positioned over the patch.
Do not fold, alter, or remove any portion of the patch as it may compromise electrode
f nction or longevity.
If a header port is n sed on the generator, the port m st be pl gged to protect the
generator.
4.5. GENERATOR EXPLANT AND DISPOSAL
Interrogate the device, and program shock therapy off prior to explanting, cleaning or
shipping the device to prevent nwanted shocks.
Ret rn all explanted generators and leads to the man fact rer.
Never incinerate the device d e to the potential for explosion. The device m st be explanted
before cremation.
12 SORIN – PLATINIUM VR – U461A

5. ADVERSE EVENTS
5. ADVERSE EVENTS
Clinical data presented in this section are from the Defender st dy.
PLATINIUM VR is similar in design and f nction to the Defender devices.
The data provided are applicable to PLATINIUM VR.
5.1. DEFENDER STUDY
Clinical st dy of Defender IV DR 612 incl ded 60 devices implanted in 60 patients, 38 in
E rope (37 patients followed for a minim m of 3 months), and 22 in the U.S. (IDE
G970282/S15) with a total device expos re of 228.7 and 30.3 device months, respectively.
No deaths, serio s adverse experiences or complications were j dged to be device-related,
as determined by the investigator. The following tables s mmarize the safety data for this
st dy.
There was 1 death in the st dy that was classified as arrhythmic. The ca se of death was
rec rrent VT/VF which occ rred 19 days post implant.
In the following tables, complications are defined as adverse device effect, which cannot be
treated or resolved by simple adj stments (e.g. reprogramming) and req ires intervention.
Observations are defined as symptomatic or asymptomatic clinical events with potential
adverse device effects that do not req ire intervention or can be corrected by simple
adj stments.
Two of the 38 Defender IV DR 612 patients in E rope (37 patients followed for a minim m of
3 months) experienced a total of three complications, incl ding device fail res and
replacements. Fo rteen of the 38 Defender IV DR 612 patients experienced a total of 18
observations. Complications and observations are reported in Tables 1 and 2. It sho ld be
noted that a patient can have more than one observation or complication. There were no
observations or complications in the U.S.
Table 1: Summary of European Clinical Complications
(Incl ding Device Fail res and Replacements)
All complications, 2 of 38 Defender IV DR 612 patients in E rope
Event # of Patients % of Patients # of Events Events/100
Device-Years*
Hematoma 1 2.6 1 5.2
Ventric lar lead
migration/dislodgment
2 5.3 2 10.5
SORIN – PLATINIUM VR – U461A 13
NOTE: The company classified as complications those adverse device effects that were
treated with s rgery or with external defibrillation of a ventric lar cardiac event.
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.

5. ADVERSE EVENTS
* There were 228.7 device months in this st dy.
Table 2: Summary of European Clinical Complications
(Incl ding Patient Complaints)
All complications, 14 of 38 Defender IV DR 612 patients in E rope
Event # of Patients* % of Patients # of Events Events/100
Device-
Years**
Change in ventric lar sensing
threshold
1 2.6 1° 5.2
Device reset*** 1 2.6 1° 5.2
Inappropriate therapy for EMI 1 2.6 1° 5.2
Pne mothorax 1 2.6 1° 5.2
Pocket hematoma 2 5.3 2° 10.5
Pocket infection/hematoma 1 2.6 1° 5.2
Pocket infection from previo s
pacemaker
1 2.6 1° 5.2
Prolonged implant proced re 1 2.6 1 5.2
Sensor acceleration d ring
telemetry***
1 2.6 1 5.2
Shock for VT in VF Zone 1 2.6 1° 5.2
Slow VT not converted by ATP
therapy
1 2.6 2° 10.5
Unsatisfactory sensing
threshold test***
2 5.3 2 10.5
Ventric lar oversensing 3 7.9 3 15.7
* A patient can have more than one observation.
** There were 228.7 device months in this st dy.
***These observations wo ld not have happened with the c rrently marketed device and
programmer.
°Investigator indicated that Defender IV DR did not ca se or contrib te to the event.
14 SORIN – PLATINIUM VR – U461A

6. CLINICAL STUDIES
6. CLINICAL STUDIES
Clinical data presented in this section are from the Defender st dy.
PLATINIUM VR is similar in design and f nction to the Defender devices.
The data provided are applicable to PLATINIUM VR.
6.1. DEFENDER STUDY
Objectives:
The primary objectives of this st dy were to demonstrate a complication free rate (CFR)
comparable to that of historical controls, to demonstrate, sing a chronotropic assessment
exercise protocol (CAEP), a rate response proportional to and appropriate for the level of
exercise, and to eval ate and report the incidence of adverse events.
Materials:
Each patient received one Defender IV DR 612 defibrillator, an atrial pacing and sensing
lead, and a Medtronic, Angeion, or Biotronik defibrillation lead in the U.S. or any
commercially available defibrillator lead o tside the U.S.
Methods:
Investigators selected patients who s rvived at least one episode of cardiac arrest
(manifested by loss of conscio sness) pres mably d e to a ventric lar tachyarrhythmia or
exhibited rec rrent, poorly tolerated, s stained ventric lar tachycardia (VT). The protocol
req ired eval ation of performance and adverse events at pre-discharge, one month, three
months, six months, and (in the U.S.) every three months thereafter. At the one-month visit,
eligible patients performed a chronotropic assessment exercise protocol (CAEP) maximal
exercise test.
Study Population.
The table below s mmarizes incl sions.
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
E rope 04-May-99 26-J l-99 14-Apr-00 11 38
All 04-May-99 08-Mar-00 14-Apr-00 (E r),
14-Mar-00 (US)
17 60
6.1.1. Complication-free rate
Only E ropean patients followed for at least 3 months:
Symbol Parameter Defender IV DR 612
N Overall n mber of patients 37
Pe*N N mber of s ccesses 35
SORIN – PLATINIUM VR – U461A 15

6. CLINICAL STUDIES
Pe Observed experimental
proportion
0.95
Ps N ll hypothesis s ccess rate 0.76
ES Estimated standard error of Pe 0.04
z´ Test statistic (1) 4.75
p Associated p-val e < 0,0001
(1) Statistical test: z´ = (Pe-Ps)/SE where SE = sqrt(Pe(1-Pe)/N)
6.1.2. Rate response
E ropean 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
E rope 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 b t did
not
0 0 0.0
Non-device related
death
0 0 0.0
Explant 0 0 0.0
Complication 0 0 0.0
Observation 0 0 0.0
Serio s non-related
other than death
1 1 4.5
16 SORIN – PLATINIUM VR – U461A

6. CLINICAL STUDIES
Event Europe (N=38) Number of events* Number of patients Percent of patients
Intent to treat b t did
not
0 0 0.0
Non-device related
death
1 1 2.6
Explant 1 1 2.6
Complication 3 2 5.3
Observation 18 14 36.8
Serio s non-related
other than death
12 7 18.4
Event All (N=60) Number of events* Number of patients Percent of patients
Intent to treat b t did
not
0 0 0.0
Non-device related
death
1 1 1.7
Explant 1 1 1.7
Complication 3 2 3.3
Observation 18 14 23.3
Serio s non-related
other than death
13 8 13.3
* A patient can have more than one complication, observation, or serio s adverse event, not
device-related.
Device Failures and Replacements:
No device fail res or replacements occ rred with Defender IV DR 612 d ring the st dy.
SORIN – PLATINIUM VR – U461A 17

7. PATIENT SELECTION AND TREATMENT
. PATIENT SELECTION AND TREATMENT
.1. INDIVIDUALIZATION OF TREATMENT
Exercise stress testing:
If the patient’s condition permits, se exercise stress testing to:
─Determine the maxim m rate of the patient’s normal rhythm,
─Identify any s praventric lar tachyarrhythmias,
─Identify exercise-ind ced tachyarrhythmias.
The maxim m exercise rate or the presence of s praventric lar tachyarrhythmias may
infl ence selection of programmable parameters. Holter monitoring or other extended ECG
monitoring also may be helpf l.
Electrophysiologic (EP) testing:
EP testing may be sef l for ICD candidates.
EP testing may identify the classifications and rates of all the ventric lar and atrial
arrhythmias, whether spontaneo s or d ring EP testing.
Drug resistant supraventricular tachyarrhythmias (SVTs):
Dr g resistant s praventric lar tachyarrhythmias (SVTs) may initiate freq ent nwanted
device therapy.
A caref l choice of programming options is necessary for s ch patients.
Antiarrhythmic drug therapy:
If the patient is being treated with antiarrhythmic or cardiac dr gs, the patient sho ld be on a
maintenance dr g dose rather than a loading dose at the time of ICD implantation. If
changes to dr g therapy are made, repeated arrhythmia ind ctions are recommended to
verify ICD detection and conversion. The ICD also may need to be reprogrammed.
Changes in a patient’s antiarrhythmic dr g or any other medication that affects the patient’s
normal cardiac rate or cond ction can affect the rate of tachyarrhythmias and/or efficacy of
therapy.
Direct any q estions regarding the individ alization of patient therapy to Sorin’s
representative.
18 SORIN – PLATINIUM VR – U461A
CAUTION: To avoid inappropriate therapy d ring an exercise stress test, do not reprogram
any parameter d ring the test. When a parameter is reprogrammed, algorithm forces
acceleration to "ventric lar". D ring cond cted sin s tachycardia within the programmed
Tachy zone, the device detects a 1:1 fast rhythm. Ass ming that acceleration was set to
ventric lar by reprogramming, the device may identify this as a VT, and may immediately
apply the corresponding therapy.