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6. CLINICAL STUDIES

Event Europe (N=38)

Number of events*

Number of patients

Percent of patients

Intent to treat but did
not

0.0

Non-device related
death

2.6

Explant

2.6

Complication

5.3

Observation

36.8

Serious non-related
other than death

18.4

Event All (N=60)

Number of events*

Number of patients

Percent of patients

Intent to treat but did
not

0.0

Non-device related
death

1.7

Explant

1.7

Complication

3.3

Observation

23.3

Serious non-related
other than death

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 during the study.

SORIN – INTENSIA VR 124 – U153A

Содержание Intensia VR 124

Страница 1: ...Implant manual Implantable cardioverter defibrillator VR model 124...

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Страница 5: ...21 10 Physician guidelines 24 10 1 Physician 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...

Страница 6: ...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 shock energy and voltage 44...

Страница 7: ...ENSIA VR 124 is also equipped with the RF wireless technology which enables to remotely monitor the patients who have the Sorin SMARTVIEW Monitor installed at home INTENSIA VR 124 provides high energy...

Страница 8: ...f the following situations Survival of at least one episode of cardiac arrest manifested by the loss of consciousness due to ventricular tachyarrhythmia Recurrent poorly tolerated sustained ventricula...

Страница 9: ...ransient or reversible causes such as acute myocardial infarction digitalis intoxication drowning electrocution electrolyte imbalance hypoxia sepsis or unstable ischemic episodes who present incessant...

Страница 10: ...Shock Therapy to OFF during surgical implant and explant or post mortem procedures The device can deliver a serious high energy shock should accidental contact be made with the defibrillation electro...

Страница 11: ...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 Ex...

Страница 12: ...the device or accessories if the packaging is wet punctured opened or damaged because the integrity of the sterile packaging may be compromised Return the device to the manufacturer Device Storage Sto...

Страница 13: ...izer to secure the lead lateral to the venous entry site Do not immerse the lead in mineral oil silicone oil or any other liquid Do not grip the lead with surgical instruments Do not use excessive for...

Страница 14: ...erior 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 longevity If a hea...

Страница 15: ...ent 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 co...

Страница 16: ...d implant procedure 1 2 6 1 5 2 Sensor acceleration during 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...

Страница 17: ...Investigators 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 to...

Страница 18: ...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...

Страница 19: ...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 re...

Страница 20: ...patients Antiarrhythmic drug therapy If the patient is being treated with antiarrhythmic or cardiac drugs the patient should be on a maintenance drug dose rather than a loading dose at the time of IC...

Страница 21: ...ce there has been no quantitative assessment of the presence of leachables in breast milk Pediatric Patients This device has not been studied in patients younger than 18 years of age Geriatric Patient...

Страница 22: ...lowing points in counselling the patient about this device Persons administering CPR may experience tingling on the patient s body surface when the patient s ICD system delivers a shock Advise patient...

Страница 23: ...tronic and electrical apparatus with the basic restrictions related to human exposure to electromagnetic fields 10 MHz 300 GHz EN 301 489 1 v1 8 1 EN 301 489 27 v1 1 1 Electromagnetic compatibility an...

Страница 24: ...ers used to communicate weather data the Meteorological Satellite or the Earth Exploration Satellite Services and must accept interference that may be caused by such stations including interference th...

Страница 25: ...est susceptible de compromettre le fonctionnement du dispositif Conform ment la r glementation d Industrie Canada le pr sent metteur radio peut fonctionner avec une antenne d un type et d un gain max...

Страница 26: ...e screen on the Sorin dedicated programmer Paper copies of Online Help can be obtained by contacting your Sorin representative 10 3 MAINTAINING DEVICE QUALITY This device is FOR SINGLE USE ONLY Do not...

Страница 27: ...n the outer storage package Additional copies can be obtained by contacting your Sorin representative or on the Sorin s web site http www sorin com This information should be given to each patient wit...

Страница 28: ...WARRANTY AND REPLACEMENT POLICY Sorin warrants its defibrillators Refer to the section Warranty for additional information Please see the following labelling sections for information concerning the pe...

Страница 29: ...one in the Slow VT and VT zones two ATP programs up to two shocks with programmable energy and up to four shocks with maximum energy can be programmed in the VF zone one ATP program up to two shocks w...

Страница 30: ...1 standard Distal lead terminal connections are secured with set screws accessed via self sealing silicone plugs All lead connections pass through the header into the device via feedthroughs Programmi...

Страница 31: ...sterile items contained in the outer storage package are the implant manual the ICD Registration Form and its envelope the patient booklet the ICD ID card and 12 identification labels Once delivered I...

Страница 32: ...at a rate higher than the programmed basic rate 14 6 DEVICE PLACEMENT The pocket should be prepared in the left pectoral position either subcutaneously or submuscularly Subcutaneous device implantatio...

Страница 33: ...o Case SVC RV to Case RV to SVC The polarity of shock is determined by the parameter itself 14 9 MEASUREMENT OF THRESHOLDS AT IMPLANT Pacing and sensing thresholds should be measured at implant Pacing...

Страница 34: ...crewdriver should remain inserted into the pre inserted screw socket when checking the tightness As a matter of fact when the lead port is filled with a liquid the physics piston effect can give the f...

Страница 35: ...ral muscle 14 12 TESTS AND PROGRAMMING During the implant testing procedure it is recommended that a security margin of at least 10 J be demonstrated between the effective shock energy and maximum pro...

Страница 36: ...hen the magnet is removed the sensor rate is forced to the basic rate arrhythmia detection algorithms and sequential therapies are reinitialized therapies start with the least aggressive program for e...

Страница 37: ...n ratio 16 6 Hz 50 Hz 60 Hz Atrial channel 75 dB 64 dB 62 dB Ventricular channel 69 dB 57 dB 56 dB 15 5 PROTECTION AGAINST SHORT CIRCUITS The defibrillator can undergo a short circuit if the anode and...

Страница 38: ...different therapies The fast VT zone is included in the VF zone its lower limit is determined by the programmed value for the VF zone and its upper limit by the programmed value for the fast VT zone...

Страница 39: ...found to be at risk during a follow up the information is managed as a warning pop up message to notify immediately the user For example the following types of event can trigger a warning or an alert...

Страница 40: ...meters Information on patient and system implanted battery status lead status brady leads and defibrillation coils pacing counters and mean heart rate brady ventricular arrhythmia counters and episode...

Страница 41: ...of noise on the V lead SORIN INTENSIA VR 124 U153A 39 WARNING The use of remote monitoring does not replace regular follow up Therefore when using remote monitoring the time period between follow ups...

Страница 42: ...date After a device reset the magnet rate is equal to 87 bpm it will be updated within the next 24 hours Refer to the online help for a description of displayed warning and the necessity to contact So...

Страница 43: ...e increases Under normal conditions and without programmer use the charge times are as follows Shock energy Charge time sec BOS 3 42 J 10 2 RTT 42 J 13 3 1 Recommended Replacement Time RRT corresponds...

Страница 44: ...rogramming head interfaced with the Sorin dedicated programmer Position the programming head over the telemetry antenna located in the upper part of the device in order to communicate effectively via...

Страница 45: ...g Volume 38 6 cm3 Active surface area of casing 76 cm2 Connector DF 4 18 1 MATERIALS USED Active surface area of casing 99 pure titanium Connectors Polyurethane and silicone elastomer Medical grade m...

Страница 46: ...elivered energies at 37 C 50 ohm load for the minimum low mean and maximum programmed energy values is as follows Stored energy J 0 5 10 20 34 42 V1 Volt 75 341 483 631 702 V2 Volt 37 173 245 318 353...

Страница 47: ...hock per quarter sensor ON 9 1 years Pacing in VVI mode 1 500 ohm 3 5 V 0 35 ms 60 bpm one 42 J shock per quarter sensor OFF 8 5 years Pacing in VVI mode 15 500 ohm 4 5 V 0 50 ms 60 bpm one 42 J shock...

Страница 48: ...edium High Very high Pacing Sensing Values Ventricular sensitivity mV 1 From 0 4 to 4 by steps of 0 2 0 4 50 Ventricular amplitude V 2 1 1 5 2 2 5 3 3 5 4 4 5 5 6 20 Ventricular pulse width ms 0 12 0...

Страница 49: ...ction zone 1 Slow VT ON Slow VT OFF VT detection zone VT ON VT OFF Fast VT VF detection zone Fast VT VF ON VF ON Slow VT rate lower limit bpm From 100 to 200 by steps of 5 190 VT rate lower limit bpm...

Страница 50: ...y for fast VT ms 30 45 65 Acceleration 6 13 19 25 31 38 44 50 Long cycle persistence extension cycles From 0 to 16 by steps of 1 10 Long cycle gap ms 15 30 45 65 80 95 110 125 140 155 170 190 205 20 3...

Страница 51: ...ogram Values ATP program OFF Burst Burst Scan Ramp Ramp Scan Number of sequences 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Cycles in first sequence 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Cycles added per seque...

Страница 52: ...ram Values ATP program OFF Burst Burst Scan Ramp Ramp Scan Number of sequences 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Cycles in first sequence 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Cycles added per sequenc...

Страница 53: ...mber of Max Shock 42 J 1 2 3 4 20 4 REMOTE ALERTS AND WARNINGS The device routinely performs security self checks and technical measurements to ensure system integrity When system integrity is found t...

Страница 54: ...mit Ohm 1500 1750 2000 2500 3000 Abnormal RV coil impedance ON OFF Abnormal SVC coil impedance ON OFF Abnormal Shock impedance 1 ON OFF 1 Normal impedance range 20 Ohm 200 Ohm Clinical status Values V...

Страница 55: ...Post ventricular pacing 220 ms 4 ms Therapies Values Waveform 1 Constant tilt 50 50 Stored energy for the Max shock 42 J Pacing amplitude during ATP therapies 7 V Actual value at 300 ms 5 3 V 1 The d...

Страница 56: ...dioverter defibrillator must be implanted prior to the use before date indicated on the packaging 4 The limited guarantee only applies to suspect devices returned to the manufacturer carefully packed...

Страница 57: ...period starting from the implantation date Sorin is committed to replacing free of charge the explanted device by a Sorin device with equivalent features or issuing a replacement credit equal to the...

Страница 58: ...41 315 5 776 164 5 776 165 5 818 703 5 836 980 5 868 793 5 891 170 5 891 184 5 899 931 5 931 856 5 935 153 5 954 660 5 978 708 6 181 968 6 230 058 6 236 111 6 251 703 6 256 206 6 307 261 6 337 996 6 3...

Страница 59: ...ng ethylene oxide Temperature limitation High voltage Consult instruction for use This icon is used to call your attention to a particularly important point This icon alerts you to a hazard that may r...

Страница 60: ...CRM USA Inc Via Crescentino s n 14401 West 65th Way 13040 Saluggia VC Italy Arvada CO 80004 USA Tel 39 0161 487095 Tel 877 663 7674 Facsimile 39 0161 487524 www sorin com 2013 09 U153A CAUTION FEDERA...

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