sorin Intensia DR 154 User manual

Implant manual
Implantable cardioverter defibrillator
DR model 154

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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, stora e and handlin ..........................................................................................10
4.3. Implantation and device pro rammin ....................................................................................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
5.2. SafeR (AAI <> DDD) study.....................................................................................................14
6. Clinical studies......................................................................................................................16
6.1. Defender study........................................................................................................................16
6.2. SafeR (AAI <> DDD) study.....................................................................................................18
. Patient selection and treatment...........................................................................................22
7.1. Individualization of treatment..................................................................................................22
7.2. Specific patient populations....................................................................................................23
8. Patient counselling information..........................................................................................24
9. Conformance to standards..................................................................................................25
10. Physician guidelines.............................................................................................................28
10.1. Physician trainin ....................................................................................................................28
10.2. Directions for use.................................................................................................................... 28
10.3. Maintainin device quality.......................................................................................................28
11. Patient information...............................................................................................................29
12. How supplied.........................................................................................................................30
12.1. Sterility.................................................................................................................................... 30
12.2. Warranty and replacement policy............................................................................................30
13. Device description................................................................................................................31
14. Implant procedure.................................................................................................................33
14.1. Necessary equipment.............................................................................................................33
14.2. Packa in ............................................................................................................................... 33
14.3. Optional equipment.................................................................................................................33
14.4. Before openin the packa e...................................................................................................34
14.5. Prior to implantation................................................................................................................ 34
14.6. Device placement.................................................................................................................... 34
14.7. Choosin the type of lead.......................................................................................................34
14.8. Shock confi uration (+ -> -).....................................................................................................35
14.9. Measurement of thresholds at implant....................................................................................35
14.10.Lead connection .....................................................................................................................36
14.11. Device implantation.................................................................................................................37
14.12.Tests and pro rammin ...........................................................................................................37
15. Special modes....................................................................................................................... 38
15.1. Safety mode (nominal values).................................................................................................38
SORIN – INTENSIA DR 154 – U152A 3

15.2. Ma net mode.......................................................................................................................... 38
15.3. Response in the presence of interference..............................................................................38
15.4. Detection characteristics in the presence of electroma netic fields........................................39
15.5. Protection a ainst short-circuits..............................................................................................39
16. Main functions.......................................................................................................................40
16.1. Automatic lead measurements................................................................................................40
16.2. Atrial tachyarrhythmia mana ement.......................................................................................40
16.3. Ventricular tachyarrhythmia mana ement...............................................................................40
16.4. Pacin ..................................................................................................................................... 40
16.5. Sensin ................................................................................................................................... 41
16.6. Follow-up function...................................................................................................................41
16.7. Remote Monitorin function....................................................................................................42
1 . Patient follow-up................................................................................................................... 44
17.1. Follow-up recommendations...................................................................................................44
17.2. Holter Function........................................................................................................................44
17.3. Recommended Replacement Time (RRT)..............................................................................45
17.4. Explantation............................................................................................................................45
17.5. Defibrillator identification.........................................................................................................46
18. Physical characteristics....................................................................................................... 4
18.1. Materials used.........................................................................................................................47
19. Electrical characteristics......................................................................................................48
19.1. Table of delivered shock ener y and volta e..........................................................................48
19.2. Battery.....................................................................................................................................48
19.3. Lon evity................................................................................................................................. 49
20. Programmable parameters...................................................................................................50
20.1. Antibradycardia pacin ............................................................................................................50
20.2. Ventricular tachyarrhythmia detection.....................................................................................53
20.3. Ventricular tachyarrhythmia therapies.....................................................................................54
20.4. Remote alerts and warnin s...................................................................................................57
21. Non programmable parameters...........................................................................................59
22. Limited warranty...................................................................................................................60
22.1. Article 1 : Terms of limited warranty........................................................................................60
22.2. Article 2 : Terms of replacement..............................................................................................61
23. Patents................................................................................................................................... 62
24. Explanation of symbols........................................................................................................63
4SORIN – INTENSIA DR 154 – U152A

1. GENERAL DESCRIPTION
1. GENERAL DESCRIPTION
INTENSIA DR 154 is an implantable dual-chamber cardioverter defibrillator. It is equipped
with an accelerometer to allow adaptation of pacin to suit the patient’s activity.
INTENSIA DR 154 is also equipped with the RF wireless technolo y which enables to
remotely monitor the patients who have the Sorin SMARTVIEW Monitor installed at home.
INTENSIA DR 154 provides hi h ener y shocks (42 J) for enhanced safety, as well as
automatic lead measurements to monitor system inte rity.
INTENSIA DR 154 is protected a ainst hi h-frequency si nals emitted by cellular
telephones.
SORIN – INTENSIA DR 154 – U152A 5

2. INDICATIONS
2. INDICATIONS
INTENSIA DR 154 is indicated for use in patients who are at hi h risk of sudden cardiac
death due to ventricular tachyarrhythmias and who have experienced one of the followin
situations:
─Survival of at least one episode of cardiac arrest (manifested by the loss of
consciousness) due to ventricular tachyarrhythmia,
─Recurrent, poorly tolerated sustained ventricular tachycardia (VT).
NOTE: The clinical outcome for hemodynamically stable VT patients is not fully known.
Safety and effectiveness studies have not been conducted.
6SORIN – INTENSIA DR 154 – U152A

3. CONTRAINDICATIONS
3. CONTRAINDICATIONS
Implantation of INTENSIA DR 154 is contraindicated in patients:
─whose ventricular tachyarrhythmias may have transient or reversible causes such as:
acute myocardial infarction, di italis intoxication, drownin , electrocution, electrolyte
imbalance, hypoxia, sepsis, or unstable ischemic episodes,
─who present incessant tachyarrhythmia,
─who have an internal pacemaker,
─whose primary disorder is bradyarrhythmias, or atrial tachyarrhythmias.
Dual-chamber and sin le chamber atrial pacin is contraindicated in patients with chronic
refractory atrial tachyarrhythmias.
SORIN – INTENSIA DR 154 – U152A 7

4. WARNINGS AND PRECAUTIONS
4. WARNINGS AND PRECAUTIONS
The patient should be warned of the potential risks of defibrillator malfunction if he is
exposed to external ma netic, electrical, or electroma netic si nals.
These potential interference sources may cause conversion to inhibited mode (because of
noise detection), erratic delivery of VT or VF therapies, nominal pro rammin , or much more
rarely, irreversible dama e to the device’s circuits.
The main sources of hi h ma nitude electroma netic interference (EMI) are: powerful
radiofrequency equipment (radar), industrial motors and transformers, induction furnaces,
resistance, arc-weldin equipment and hi h power loudspeakers.
Resuscitation Availability:
Do not perform device testin unless an external defibrillator and medical personnel skilled
in cardiopulmonary resuscitation (CPR) are readily available.
Electrical Isolation:
Do not permit the patient to contact rounded equipment that could produce hazardous
leaka e current. Ensuin arrhythmia induction could result in the patient’s death.
Disable the ICD During Handling:
Pro ram Shock Therapy to OFF durin sur ical implant and explant or post mortem
procedures. The device can deliver a serious hi h ener y shock should accidental contact
be made with the defibrillation electrodes.
Antitheft gates:
Since antitheft devices at the entrance to stores are not subject 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 subject to any safety standards, it is advisable to
spend as little time as possible in their vicinity.
High voltage power transmission lines:
Hi h volta e power transmission lines may enerate enou h EMI to interfere with
defibrillator operation if approached too closely.
Communication equipment:
Communication equipment such as microwave transmitters, linear power amplifiers, or hi h-
power amateur transmitters may enerate enou h EMI to interfere with defibrillator
operation if approached too closely.
Home appliances:
Home appliances that are in ood workin order and properly rounded do not usually
produce enou h EMI to interfere with defibrillator operation. There are reports of device
disturbances caused by electric hand tools or electric razors used directly over the device
implant site.
8SORIN – INTENSIA DR 154 – U152A

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 durin which an electrical current from an external source passes throu h the
patient's body.
Magnetic Resonance Imaging:
MRI is strictly contraindicated in cardiac defibrillator patients.
Radiofrequency ablation:
A radiofrequency ablation procedure in a patient with a enerator may cause device
malfunction or dama e. RF ablation risks may be minimized by:
1. Pro rammin Shock Therapy and ATP to OFF.
2. Avoidin direct contact between the ablation catheter and the implanted lead or enerator.
3. Positionin the round, placin it so that the current pathway does not pass throu h or
near the device, i.e. place the round plate under the patient’s buttocks or le s.
4. Havin external defibrillation equipment available.
Electrocautery or diathermy device:
Diathermy and electrocautery equipment should not be used. If such devices must be used:
1. Keep the current path and round plate as far away from the device and the leads as
possible (a minimum of 15 cm [six inches]).
2. Before procedure, disable ATP and shock therapies.
3. Durin the procedure, keep the electrocautery device as far as possible from the cardiac
defibrillator. Set it at minimum intensity. Use it briefly.
4. After the procedure, check for proper implant function. The device should never be
exposed directly to the diathermy source.
External defibrillation:
INTENSIA DR 154 is protected from external defibrillation shocks.
1. Before external defibrillation, disable ATP and shock therapies.
2. Durin external defibrillation, it is advisable to avoid placin the defibrillatin paddles
directly over the casin or over the leads. The defibrillatin paddles should preferably be
placed in an anteroposterior position.
3. Avoid any direct contact between the defibrillation paddles and the conductive parts of the
implanted leads or casin of the implanted device.
4. After external defibrillation, check for proper device function.
Radiation therapy:
Avoid exposure to ionizin radiation. Betatrons are contraindicated. If hi h doses of radiation
therapy cannot be avoided, the defibrillator should be protected from direct exposure with a
protection shield. ATP and shock therapies should be disabled durin exposure and proper
device function should be checked re ularly afterwards. Resultin dama e may not be
SORIN – INTENSIA DR 154 – U152A 9
CAUTION: Do not tap sharply on the ICD can after implant, because the ICD's sensin
circuits can detect this as P-waves or R-waves, and such oversensin could result in
inappropriate pacin , inhibition, or therapy. Normal activities after implant do not result in
such oversensin .

4. WARNINGS AND PRECAUTIONS
immediately detectable. If irradiation of tissues close to the implantation site is necessary, it
is recommended that the cardiac defibrillator be moved. As a safety measure, an external
defibrillator should be immediately available.
Lithotripsy:
Lithotripsy may permanently dama e the device if it is at the focal point of the lithotripsy
beam. If lithotripsy must be used, keep the defibrillator at least 2.5 to 5 cm (1-2 inches) away
from the focal point of the lithotripsy beam.
Diagnostic ultrasound (echography):
The defibrillator is not affected by ultrasound ima in devices.
Scales with body fat monitors and electronic muscle stimulators:
A patient with an implanted INTENSIA DR 154 should not use 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 outer stora e packa e and on the sterile packa e. Do
not implant the device after this date because the battery may have reduced lon evity and
sterility may be affected. It should be returned to Sorin.
If Package is damaged:
Do not use the device or accessories if the packa in is wet, punctured, opened or
dama ed because the inte rity of the sterile packa in may be compromised. Return the
device to the manufacturer.
Device Storage:
Store the device in a clean area, away from ma nets, kits containin ma nets, and sources
of electroma netic interference to avoid device dama e. Store the device between 0 - 50 °C
(32 - 122 °F). Temperatures outside the specified ran e may dama e the device.
Equilibration:
Allow the device to reach room temperature before pro rammin or implantin the device
because rapid temperature chan es may affect initial device function.
4.3. IMPLANTATION AND DEVICE PROGRAMMING
Use only a Sorin pro rammer to communicate with the device.
Do not inadvertently position any ma net over the ICD; this suspends tachyarrhythmia
detection and treatment.
Replace the device when the RRT (Recommended Replacement Time*) point (defined by a
battery volta e of 2.66 ± 0.01 V or a ma net rate lower than or equal to 80 bpm) is reached.
Pro ram device parameters such as sensitivity threshold and VT and VF detection intervals
as specified in the device manuals.
Lead System:
Do not use a lead system other than those with demonstrated compatibility because
undersensin cardiac activity and failure to deliver necessary therapy may result.
10 SORIN – INTENSIA DR 154 – U152A

4. WARNINGS AND PRECAUTIONS
In situations where an ICD and a pacemaker are implanted in the same patient, interaction
testin should be completed. If the interaction between the ICD and the pacemaker cannot
be resolved throu h repositionin of the leads or repro rammin of either the pacemaker or
the ICD, the pacemaker should not be implanted (or should be explanted if previously
implanted).
Failure to properly insert the torque screwdriver into the perforation at an an le
perpendicular to the connector receptacle may result in dama e to the sealin system and
its self-sealin properties.
It is recommended that a security mar in of at least 10 J be demonstrated between the
effective shock ener y and maximum pro rammable ener y. Carefully confirm that true
ventricular fibrillation has been induced because the DFT for ventricular tachycardia or flutter
may be lower.
The defibrillator should be implanted with the en raved side facin outwards in order to
facilitate telemetric communication with the pro rammin head and to display the
radio raphic identification correctly.
*: corresponds to ERI (Elective Replacement Indicator) previously used.
4.4. LEAD EVALUATION AND LEAD CONNECTION
INTENSIA DR 154 has one IS-1, and one DF-4 connector ports.
IS-1 refers to the international standard whereby leads and enerators from different
manufacturers are assured a basic fit (ISO 5841-1:2000).
DF-4 refers to the international standard for defibrillation lead connectors (ISO 27186:2010).
Do not use the device with leads which have not been positively tested.
Do not tie a li ature directly to the lead body, tie it too ti htly, or otherwise create excessive
strain at the insertion site as this may dama e the lead. Use the lead stabilizer to secure the
lead lateral to the venous entry site.
Do not immerse the leads in mineral oil, silicone oil, or any other liquid.
Do not rip the lead with sur ical instruments.
Do not use excessive force or sur ical instruments to insert a stylet into a lead.
Use ventricular transvenous leads with caution in patients with either a mechanical or
bioprosthetic tricuspid valvular prosthesis.
Use the correct suture sleeve (when needed) for each lead, to immobilize the lead and
protect it a ainst dama e from li atures.
Never implant the system with a lead system that has a measured shock impedance of less
than 30 ohms. A protection circuit 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 reater distance between the electrodes.
Do not kink leads. Kinkin leads may cause additional stress on the leads, possibly resultin
in lead fracture.
Do not insert a lead connector pin into the connector block without first visually verifyin that
the setscrews are sufficiently retracted. Do not ti hten the setscrews unless a lead
connector pin is inserted because it could dama e the connector block.
Lead electrodes in contact durin a cardioversion or defibrillation therapy will cause current
to bypass the heart, possibly dama in the ICD and the leads. While the ICD is connected
to the leads, make sure that the metal portions of any electrodes do not touch each other.
If a pacin lead is abandoned rather than removed, it must be capped to ensure that it is not
a pathway for currents to or from the heart.
SORIN – INTENSIA DR 154 – U152A 11

4. WARNINGS AND PRECAUTIONS
If a thoracotomy is required to place epicardial patches, it should be done durin a separate
procedure to reduce the risk of morbidity and mortality.
Do not place the patch lead over nerve tissue as this may cause nerve dama e.
Place the patch lead with the conductin coil side facin the heart to ensure delivery of
ener y to the heart.
Place the sutures well outside the coil of the patch lead or in the area between the coils to
avoid possible coil fracture.
If countershock is unsuccessful usin external paddles, adjust the external paddle position
(e. ., anterior-lateral to anterior-posterior) and be sure 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
function or lon evity.
If a header port is unused on the enerator, the port must be plu ed to protect the
enerator.
4.5. GENERATOR EXPLANT AND DISPOSAL
Interro ate the device, and pro ram shock therapy off prior to explantin , cleanin or
shippin the device to prevent unwanted shocks.
Return all explanted enerators and leads to the manufacturer.
Never incinerate the device due to the potential for explosion. The device must be explanted
before cremation.
12 SORIN – INTENSIA DR 154 – U152A

5. ADVERSE EVENTS
5. ADVERSE EVENTS
Clinical data presented in this section are from the Defender and SafeR (AAI <> DDD)
clinical studies. INTENSIA DR 154 is similar in desi n and function to the Defender
devices.SafeR (AAI <> DDD) operation in INTENSIA is similar to that in the Symphony
pacemaker. The data provided are applicable to INTENSIA DR 154.
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 months), and 22 in the U.S. (IDE
G970282/S15) with a total device exposure of 228.7 and 30.3 device months, respectively.
No deaths, serious adverse experiences or complications were jud ed to be device-related,
as determined by the investi ator. The followin tables summarize the safety data for this
study.
There was 1 death in the study that was classified as arrhythmic. The cause of death was
recurrent VT/VF which occurred 19 days post implant.
In the followin tables, complications are defined as adverse device effect, which cannot be
treated or resolved by simple adjustments (e. . repro rammin ) 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 with potential
adverse device effects that 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 the 38 Defender IV DR 612 patients in Europe (37 patients followed for a minimum of
3 months) experienced a total of three complications, includin device failures and
replacements. Fourteen 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 should 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
(Includin 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
mi ration/dislod ment
2 5.3 2 10.5
* There were 228.7 device months in this study.
Table 2: Summary of European Clinical Complications
(Includin Patient Complaints)
SORIN – INTENSIA DR 154 – U152A 13

5. ADVERSE EVENTS
All complications, 14 of 38 Defender IV DR 612 patients in Europe
Event # of Patients* % of Patients # of Events Events/100
Device-
Years**
Chan e in ventricular sensin
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
Pneumothorax 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 previous
pacemaker
1 2.6 1° 5.2
Prolon ed implant procedure 1 2.6 1 5.2
Sensor acceleration durin
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 sensin
threshold test***
2 5.3 2 10.5
Ventricular oversensin 3 7.9 3 15.7
* A patient can have more than one observation.
** There were 228.7 device months in this study.
***These observations would not have happened with the currently marketed device and
pro rammer.
°Investi ator indicated that Defender IV DR did not cause or contribute to the event.
5.2. SAFER (AAI <> DDD) STUDY
Clinical study of the SafeR (AAI <> DDD) included 45 Symphony 2550 devices implanted in
45 patients. No serious adverse events were device- or feature-related. There were no
deaths in the study.
Table 1: Summary of Symphony safety data during study
Patients Number of events
Number of
patients
% of patients Number of
events
Events per
device year (a)
Deaths 0 0 0 0
Explants 0 0 0 0
Serious pacemaker related
events outside the use of
SafeR (AAI <> DDD)
0 0 0 0
14 SORIN – INTENSIA DR 154 – U152A

5. ADVERSE EVENTS
Non-serious pacemaker
related events outside the use
of SafeR (AAI <> DDD)
0 0 0 0
Serious events due to the use
of SafeR (AAI <> DDD)
0 0 0 0
Non-serious events related due
to the use SafeR (AAI <> DDD)
13 28.9 15 3.2
Serious non-pacemaker
related events
6 13.3 9 1.9
Non-serious non-pacemaker
related events
8 17.8 8 1.7
(a) 4.74 device years
Non-serious events due to the use of SafeR 2 (AAI <> DDD) included: delay in switchin on
2nd de ree AV block, inappropriate classification of a PAC, disa reement between markers
and recorded EGM, atrial pacin above the maximum rate, recyclin on an R-wave in a
refractory period, and disa reement in the statistics for switches to DDD. No patient
symptoms were associated with these events.
SORIN – INTENSIA DR 154 – U152A 15

6. CLINICAL STUDIES
6. CLINICAL STUDIES
Clinical data presented in this section are from the Defender and SafeR (AAI <> DDD)
clinical studies. INTENSIA DR 154 is similar in desi n and function to the Defender
devices.SafeR (AAI <> DDD) operation in INTENSIA is similar to that in the Symphony
pacemaker. The data provided are applicable to INTENSIA DR 154.
6.1. DEFENDER STUDY
Objectives:
The primary objectives of this study were to demonstrate a complication free rate (CFR)
comparable to that of historical controls, to demonstrate, usin a chronotropic assessment
exercise protocol (CAEP), a rate response proportional to and appropriate for the level of
exercise, and to evaluate and report the incidence of adverse events.
Materials:
Each patient received one Defender IV DR 612 defibrillator, an atrial pacin and sensin
lead, and a Medtronic, An eion, or Biotronik defibrillation lead in the U.S. or any
commercially available defibrillator lead outside the U.S.
Methods:
Investi ators selected patients who survived at least one episode of cardiac arrest
(manifested by loss of consciousness) presumably due to a ventricular tachyarrhythmia or
exhibited recurrent, poorly tolerated, sustained ventricular tachycardia (VT). The protocol
required evaluation of performance and adverse events at pre-dischar e, one month, three
months, six months, and (in the U.S.) every three months thereafter. At the one-month visit,
eli ible patients performed a chronotropic assessment exercise protocol (CAEP) maximal
exercise test.
Study Population.
The 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 months:
Symbol Parameter Defender IV DR 612
N Overall number of patients 37
Pe*N Number of successes 35
16 SORIN – INTENSIA DR 154 – U152A

6. CLINICAL STUDIES
Pe Observed experimental
proportion
0.95
Ps Null hypothesis 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 where 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
Lar e
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
death
0 0 0.0
Explant 0 0 0.0
Complication 0 0 0.0
Observation 0 0 0.0
Serious non-related
other than death
1 1 4.5
SORIN – INTENSIA DR 154 – U152A 17

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
death
1 1 2.6
Explant 1 1 2.6
Complication 3 2 5.3
Observation 18 14 36.8
Serious 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 but 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
Serious non-related
other than death
13 8 13.3
* A patient can have more than one complication, observation, or serious adverse event, not
device-related.
Device Failures and Replacements:
No device failures or replacements occurred with Defender IV DR 612 durin the study.
6.2. SAFER (AAI <> DDD) STUDY
SafeR (AAI <> DDD) mode in INTENSIA is similar to that in Symphony.
The differences in SafeR (AAI <> DDD) mode between the two devices are:
─To prevent lon RR intervals durin VT/VF, SafeR (AAI <> DDD) has no effect durin
VT/VF therapy, electrophysiolo ic studies, and post-shock recovery.
─The maximum acceptable AV delay for first de ree AV block varies as a function of
pacin rate.
─INTENSIA requires a ventricular sensed event to atrial paced event (RA) interval of at
least 100 ms. Therefore, the device len thens the atrial escape interval so that it ends at
least 102 ms after the ventricular event.
─Durin atrial fibrillation episode, pause criterion is fixed to 2s to avoid lon bradycardia
episodes in switchin to DDD mode.
Despite these differences, the data collected on Symphony devices are applicable to
INTENSIA because the principles of SafeR (AAI <> DDD) operation did not chan e. The
18 SORIN – INTENSIA DR 154 – U152A