Implant manual Implantable cardioverter defibrillator SonR CRT-D model 184
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TABLE OF CONTENTS 1. General description................................................................................................................ 5 2. Indications............................................................................................................................... 6 3. Contraindications.................................................................................................................... 7 4. 4.1. 4.2. 4.3. 4.4. 4.5. Warnings and precautions...............
15.2. 15.3. 15.4. 15.5. Magnet mode.......................................................................................................................... 37 Response in the presence of interference..............................................................................37 Detection characteristics in the presence of electromagnetic fields........................................38 Protection against short-circuits......................................................................................
1. GENERAL DESCRIPTION 1. GENERAL DESCRIPTION INTENSIA SonR CRT-D 184 is an implantable cardioverter defibrillator for the recognition and treatment of ventricular tachycardia and fibrillation, with ventricular resynchronization, in patients with spontaneous or inducible tachyarrhythmias. INTENSIA SonR CRT-D 184 is equipped with an accelerometer to allow adaptation of pacing to suit the patient’s activity.
2. INDICATIONS 2. INDICATIONS INTENSIA SonR CRT-D 184 is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias. The device is also indicated for the reduction of heart failure symptoms in medically optimized NYHA Functional Class III and IV patients with left ventricular ejection fraction of 35% or less, and a QRS duration of 150 ms or longer.
3. CONTRAINDICATIONS 3. CONTRAINDICATIONS Implantation of INTENSIA SonR CRT-D 184 is contraindicated in patients: ─ whose ventricular tachyarrhythmias may have transient or reversible causes such as: acute myocardial infarction, digitalis intoxication, drowning, 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.
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 magnetic, electrical, or electromagnetic signals. These potential interference sources may cause conversion to inhibited mode (because of noise detection), erratic delivery of VT or VF therapies, nominal programming, or much more rarely, irreversible damage to the device’s circuits.
4. WARNINGS AND PRECAUTIONS disturbances caused by electric hand tools or electric razors used directly over the device implant site. CAUTION: Do not tap sharply on the ICD can after implant, because the ICD's sensing circuits can detect this as P-waves or R-waves, and such oversensing could result in inappropriate pacing, inhibition, or therapy. Normal activities after implant do not result in such oversensing. 4.1.
4. WARNINGS AND PRECAUTIONS protection shield. ATP and shock therapies should be disabled during exposure and proper device function should be checked regularly afterwards. Resulting damage may not be 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.
4. WARNINGS AND PRECAUTIONS Lead System: Do not use a lead system other than those with demonstrated compatibility because undersensing cardiac activity and failure to deliver necessary therapy may result. In situations where an ICD and a pacemaker are implanted in the same patient, interaction testing should be completed.
4. WARNINGS AND PRECAUTIONS Lead electrodes in contact during a cardioversion or defibrillation therapy will cause current to bypass the heart, possibly damaging 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 pacing 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.
5. ADVERSE EVENTS 5. ADVERSE EVENTS Clinical data presented in this section are from the MSP clinical study. INTENSIA SonR CRT-D 184 is similar in design and function to the ALTO 2 MSP and OVATIO CRT-D devices. The data provided are applicable to INTENSIA SonR CRT-D 184. 5.1. MSP STUDY Sorin conducted an international, multi-center, randomized clinical trial of its cardiac resynchronization therapy system. Investigators attempted to implant study devices in 190 patients.
5. ADVERSE EVENTS Serious adverse events not related to the system 85 44.7 176 10.8 Worsening CHF/CHF decompensation 24 12.6 42 2.1 Atrial fibrillation/flutter 14 7.4 14 0.7 Not Serious events not related to the system 58 30.5 121 7.4 Pain (in back, arms, chest, shoulder, groin, head, other) 10 5.3 13 0.7 Worsening CHF/CHF decompensation 13 6.8 16 0.8 Atrial fibrillation/flutter 7 3.7 8 0.4 Ventricular tachycardia 5.2. 7 3.7 7 0.
5. ADVERSE EVENTS ─ Fear of premature battery depletion, ─ Fear of shocking while conscious, ─ Fear that shocking capability may be lost, ─ Imagined shocking (phantom shock).
6. CLINICAL STUDIES 6. CLINICAL STUDIES Clinical data presented in this section are from the MSP clinical study. INTENSIA SonR CRT-D 184 is similar in design and function to the ALTO 2 MSP and OVATIO CRT-D devices. The data provided are applicable to INTENSIA SonR CRT-D 184. 6.1. MSP CLINICAL STUDY OVATIO CRT-D and earlier models were evaluated clinically in an international, multi-center, randomized clinical trial of Sorin’s cardiac resynchronization therapy (CRT-D) system.
6. CLINICAL STUDIES Six-month system complication-free rate 6.1.4 . Number of patients contributing to analysis Kaplan-Meier six-month complication-free estimate One-sided lower 95% confidence bound for sixmonth complication-free estimate 190 89.5 % 84.1 % Absolute Differences in Peak VO2 and QOL The tables below show the absolute differences between the control and test groups’ peak VO2 and QOL over the 6 month follow-up period in the clinical trial.
6. CLINICAL STUDIES 6.1.5 . Clinical Results V-V timing V-V programmable settings were available for the clinical study devices as follows: ALTO MSP model 617 (not programmable for V-V delay), ALTO 2 MSP model 627 values (0, 31, 39, 47, 55 and 63 ms) and OVATIO CRT-D 6750 values (0 to 63 ms in steps of 8 ms). The graph below shows the programmed V-V settings at randomization by percentage of patients programmed to each combination of Synchronous BiV pacing and V-V delay.
6. CLINICAL STUDIES Trial, a uniform protocol was used for V-V programming. This protocol required all patients to undergo echo-guided V-V delay optimization before randomization (2 to 14 days postimplant). The optimal V-V delay was determined by finding the programmable V-V delay and ventricular chamber pacing order (RV then LV, or LV then RV) providing the maximum time velocity integral (TVI or VTI) across the left ventricular outflow tract (LVOT).
7. PATIENT SELECTION AND TREATMENT 7. PATIENT SELECTION AND TREATMENT 7.1. INDIVIDUALIZATION OF TREATMENT Exercise stress testing: If the patient’s condition permits, use exercise stress testing to: ─ Determine the maximum rate of the patient’s normal rhythm, ─ Identify any supraventricular tachyarrhythmias, ─ Identify exercise-induced tachyarrhythmias. The maximum exercise rate or the presence of supraventricular tachyarrhythmias may influence selection of programmable parameters.
7. PATIENT SELECTION AND TREATMENT 7.2. SPECIFIC PATIENT POPULATIONS Pregnancy: If there is a need to image the device, care should be taken to minimize radiation exposure to the foetus and the mother. Nursing Mothers: Although appropriate biocompatibility testing has been conducted for this implant device, 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.
8. PATIENT COUNSELLING INFORMATION 8. PATIENT COUNSELLING INFORMATION The physician should consider the following 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 patients to carry Sorin ID cards and/or ID bracelets documenting their ICD system.
9. CONFORMANCE TO STANDARDS 9. CONFORMANCE TO STANDARDS This device was developed in conformance with all or parts of the following standards: ─ EN 45502-1: 1998 – Active implantable medical devices. General requirements for safety, marking and information to be provided by the manufacturer. ─ EN 45502-2-1: 2003 – Active implantable medical devices. Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers).
9. CONFORMANCE TO STANDARDS Sorin declares that this device is in conformity with the essential requirements of Directive 1999/5/EC on Radio and Telecommunications Terminal Equipment, with the mutual recognition of their conformity (R&TTE). Federal Communication Commission Interference Statement 47 CFR Section 15.19 and 15.105(b) The FCC product ID is YSGSONRCRTD184. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules.
9. CONFORMANCE TO STANDARDS This device may not interfere with stations operating in the 400.150–406.000 MHz band in the Meteorological Aids, Meteorological Satellite, and Earth Exploration Satellite Services and must accept any interference received, including interference that may cause undesired operation. Cet appareil numérique de la classe B respecte toutes les exigences du règlement sur le matériel brouilleur du Canada.
10. PHYSICIAN GUIDELINES 10. PHYSICIAN GUIDELINES 10.1. PHYSICIAN TRAINING Physicians should be familiar with sterile pulse generator and left ventricular pacing lead implant procedures. They must apply these procedures according to professional medical training and experience. Physicians should be familiar with follow-up evaluation and management of patients with an implantable defibrillator (or referral to such a physician).
10. PHYSICIAN GUIDELINES ─ Its storage package has been pierced or altered, because this could have rendered it non-sterile. ─ It has been stored or transported outside the environmental temperature limits: 32 °F (0 °C) to 122 °F (50 °C) as an electrical reset condition may occur. ─ "Use Before" date has expired, because this can adversely affect pulse generator longevity or sterility. 10.4.
11. PATIENT INFORMATION 11. PATIENT INFORMATION Information for the patient is available in the patient booklet, contained in 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 with their first ICD and offered to the patient on each return visit or as deemed appropriate.
12. HOW SUPPLIED 12. HOW SUPPLIED 12.1. STERILITY The INTENSIA defibrillators are supplied one per package in a sterile package. 12.2. 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 performance of this device: Indications, Contraindications, Warnings and Precautions, and Adverse Events.
13. DEVICE DESCRIPTION 13. DEVICE DESCRIPTION The INTENSIA SonR CRT-D system includes the model 184 ICD device and programming system. The programming system includes the Sorin dedicated programmer with the SMARTVIEW programming software connected to a CPR3 programming head. The programming system is configured and furnished by Sorin. The INTENSIA SonR CRT-D 184 can serve as a defibrillation electrode (active housing) with a total surface area of 76 cm².
13. DEVICE DESCRIPTION ─ Programmer-controlled VT induction sequences, ─ Programmer-controlled VF inductions (30 Hz rapid pacing or shock on T), ─ Programmable electrogram vectors (EGM A, EGM V, RVcoil-CAN, SVC-CAN, RVcoilSVC, LV bip, LV tip-RV), ─ Real-time annotations displayed with the markers and indicating the majority rhythm, ─ Manual ATP sequences, ─ Manual shocks.
14. IMPLANT PROCEDURE 14. IMPLANT PROCEDURE 14.1.
14. IMPLANT PROCEDURE 14.4. BEFORE OPENING THE PACKAGE Before opening the package, check the "Use Before" date printed on the labels on the box and on the sterile package. Defibrillators that have not been implanted before that date should be returned to Sorin. Interrogate the device: ─ if a warning is displayed, do not implant the device and contact your Sorin representative.
14. IMPLANT PROCEDURE Replacement of an existing atrial lead: If the initial lead which was connected to the atrial port of the INTENSIA SonR CRT-D 184 was not a SonR lead (i.e.a conventional lead or plug), then do not implant a SonR lead as replacement; possible blood infiltration at the entrance of the connector port may prevent proper measurement of the SonR signal. NOTE1: Please note that DF-1 standard compliant lead is not compatible with DF-4 connector.
14. IMPLANT PROCEDURE Pacing thresholds: Acute thresholds should be lower than 1 V (or 2 mA) for a 0.35 ms pulse width, in both ventricles and in the atrium. Sensing thresholds: For proper right ventricular sensing, the amplitude of the R-wave should be greater than 5 mV. For proper atrial sensing, the amplitude of the P-wave should be greater than 2 mV.
14. IMPLANT PROCEDURE 6. Removing the screwdriver: to avoid all risk of loosening screws during removal, hold the screwdriver by its metal part and not by the handle. WARNING: Ensure that the screwdriver's tip is fully inserted in the setscrew; otherwise the screwdriver can damage the setscrew and prevent connection with or disconnection from the lead.
15. SPECIAL MODES 15. SPECIAL MODES 15.1. SAFETY MODE (NOMINAL VALUES) Nominal values may be rapidly restored by pressing the following button on the programming head or programmer keyboard: or via the Emergency button on the SMARTVIEW screen. In safety mode, the defibrillator operates with the parameters underlined in the table of programmable parameters. 15.2.
15. SPECIAL MODES 15.4. DETECTION CHARACTERISTICS IN THE PRESENCE OF ELECTROMAGNETIC FIELDS Per Clause 27.4 of Standard EN 45502-2-2, detection in the presence of electromagnetic fields is characterized as follows: ─ Differential mode: ─ Common mode rejection ratio: 16.6 Hz 50 Hz 60 Hz Atrial channel ≥ 75 dB 64 dB 62 dB Ventricular channel ≥ 69 dB ≥ 57 dB ≥ 56 dB Modulated interference: For atrial sensitivity setting of 0.
16. MAIN FUNCTIONS 16. MAIN FUNCTIONS 16.1. AUTOMATIC LEAD MEASUREMENTS Automatic pacing lead impedance measurement: A lead impedance measurement is automatically performed on atrial and ventricular leads every 6 hours. The daily mean impedance is stored for each chamber. Automatic coil impedance measurement: A coil impedance measurement is automatically performed on RV and SVC coils once a week. The result is stored in the device memory. 16.2.
16. MAIN FUNCTIONS Post-shock mode: After any automatic shock therapy, the post-shock mode makes it possible to apply a pacing mode other than the standard antibradycardia pacing mode and/or with different pacing parameters. SafeR (AAI <> DDD) mode: Is intended to minimize deleterious ventricular pacing. The defibrillator functions in AAI mode, and temporarily switches to DDD mode upon the occurrence of AVB III, AVB II, AVB I and ventricular pause.
16. MAIN FUNCTIONS 16.7. FOLLOW-UP FUNCTION Storage of memory data: AIDA+ (Automatic Interpretation for Diagnosis Assistance) software provides access up to 6 months of patient follow-up with day by day data collection, or up to 24 hours with hourly data collection. Episodes of ventricular tachyarrhythmia are recorded with the programmable EGM channels: either by selecting up to two traces, or by selecting "Double V" which enables a one-channel recording that is twice as long.
16. MAIN FUNCTIONS 16.8.3 . Data transmitted The data transmitted are identical to the data available during a standard interrogation with the dedicated programmer.
17. PATIENT FOLLOW-UP 17. PATIENT FOLLOW-UP 17.1. FOLLOW-UP RECOMMENDATIONS Before the patient is discharged and at each subsequent follow-up visit, it is advisable to: ─ check the occurrence of system warnings ─ check the battery status, NOTE: If the last reforming, charge or shock occurred during the week preceding the interrogation, the last battery value may be still impacted by the event. One week post event, the battery will recover its steady state value.
17. PATIENT FOLLOW-UP ─ Markers: Atrial, ventricular and biventricular markers, sensed, paced and in relative refractory periods, ─ EGM: onset and detection of the arrhythmia, on two therapies, and the return to slow rhythm by recording electrogram.
17. PATIENT FOLLOW-UP All explanted defibrillators should be returned to Sorin, carefully cleaned of all traces of contamination. This may be done by immersing them in an aqueous sodium hypochlorite containing at least 1% chlorine, followed by rinsing copiously with water. The defibrillator should be protected against mechanical impact and the temperature variations that may occur during shipping. Before explantation, it is advisable to: 17.5.
18. SUPPLEMENTAL INFORMATION 18. SUPPLEMENTAL INFORMATION Clinical data presented in this section are from the SafeR (AAI <> DDD) clinical study. SafeR (AAI <> DDD) operation in INTENSIA is similar to that in the Symphony pacemaker. The data provided are applicable to INTENSIA SonR CRT-D 184. 18.1. ADVERSE EVENTS IN THE 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.
18. SUPPLEMENTAL INFORMATION refractory period, and disagreement in the statistics for swuitches to DDD. No patient symptoms were associated with these events. 18.2. SAFER (AAI <> DDD) CLINICAL 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 long RR intervals during VT/VF, SafeR (AAI <> DDD) has no effect during VT/VF therapy, electrophysiologic studies, and post-shock recovery.
18. SUPPLEMENTAL INFORMATION The graph shows that many patients programmed to SafeR (AAI <> DDD) had less than 1% ventricular pacing: ─ 84 % of patients without AV block at implant. ─ 63 % of patients with AV block at implant. In a representative reference group(1) of patients programmed to DDD, none had less than 1 % ventricular pacing and only 10 % had less than 90 % ventricular pacing regardless of AV block indication at implant.
19. PHYSICAL CHARACTERISTICS 19. PHYSICAL CHARACTERISTICS 19.1. Dimensions 68.4 x 73.4 x 11 mm Weight 96 g Volume 38.6 cm3 Active surface area of casing 76 cm2 Connector Atrium: SonR. Right ventricle: DF-4. Left ventricle: IS-1. MATERIALS USED Active surface area of casing 99% pure titanium Connectors Polyurethane* and silicone elastomer* *Medical-grade materials that have undergone "in vitro" and "in vivo" qualifications.
20. ELECTRICAL CHARACTERISTICS 20. ELECTRICAL CHARACTERISTICS Atrial input impedance 80 kilohms ± 30 % Ventricular input impedance 80 kilohms ± 30 % D.C. capacitance 148 µF ± 8 % Capacitor formation No formation required Rate limit 192 bpm ± 10 bpm Pacing waveform Defibrillation waveform 20.1.
20. ELECTRICAL CHARACTERISTICS 20.3. Total capacity 1964 mAh Usable capacity Between BOS and RRT: 1278 mAh. Between BOS and EOS: 1675 mAh. Voltage BOS: 3.25 V. RRT: 2.66 V. EOS: 2.5 V. LONGEVITY The longevities mentioned below are calculated by taking into account 6 months storage. 5.1 years Biventricular pacing in DDD mode, 100%, 500 ohm, 3.5 V, 0.35 ms, 60 bpm, one 42 J shock per quarter, sensors OFF 4.6 years Biventricular pacing in DDD mode, 100%, 500 ohm, 3.5 V, 0.
21. PROGRAMMABLE PARAMETERS 21. PROGRAMMABLE PARAMETERS measured at 37 °C under a 500 ohm load Legend: Value in bold: "as shipped" value Underlined value: nominal value 21.1.
21. PROGRAMMABLE PARAMETERS Pacing/Sensing Values Atrial sensitivity (mV) (1) From 0.2 to 4 by steps of 0.2 ; 0.4 (± 50 %) Atrial amplitude (V) (2) 1-1.5-2-2.5-3-3.5-4-4.5-5-6 (± 20 %) Atrial pulse width (ms) 0.12-0.25-0.35-0.5-0.6-0.75-0.85-1 (± 10 %) Ventricular sensitivity (mV) (1) From 0.4 to 4 by steps of 0.2 ; 0.4 (± 50 %) RV amplitude (V) (2) 1-1.5-2-2.5-3-3.5-4-4.5-5-6 (± 20 %) RV pulse width (ms) 0.12-0.25-0.35-0.5-0.6-0.75-0.85-1 (± 10 %) LV amplitude (V) (2) 0.25 (± 50 %) 0.5-0.
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21. PROGRAMMABLE PARAMETERS 21.2. Response to noise Values Automatic sensitivity on noise ON-OFF V pacing on noise ON-OFF SafeR (AAI <=> DDD) parameters Values AVB I switch Rest+Exercise-Exercise Long PR: max (ms) From 200 to 500 by steps of 50 ; 450 Long PR: min (ms) From 200 to 500 by steps of 50 ; 250 Max.
21. PROGRAMMABLE PARAMETERS 21.3.
21. PROGRAMMABLE PARAMETERS 21.3.1 .
21. PROGRAMMABLE PARAMETERS 21.3.2 .
21. PROGRAMMABLE PARAMETERS 21.3.3 .
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22. NON PROGRAMMABLE PARAMETERS 22.
23. LIMITED WARRANTY 23. LIMITED WARRANTY The INTENSIA implantable cardioverter defibrillator is the result of highly advanced research and all components have been selected after exhaustive testing. Sorin Group Italia S.r.l.
23. LIMITED WARRANTY link to a component failure or a production hazard. The device battery longevity varies with the type and number of delivered therapies. 8. Legal requirements of jurisdictions where the INTENSIA device is distributed will supersede any warranty conditions indicated in this manual that conflict with such laws. 23.2. ARTICLE 2 : TERMS OF REPLACEMENT 1.
24. PATENTS 24.
25. EXPLANATION OF SYMBOLS 25. EXPLANATION OF SYMBOLS The symbols on product labelling have the following meaning: Use by Date of manufacture Manufacturer Serial number Batch number For single use only. Sterilised using 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 result in equipment damage or personal injury.
CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN Manufactured in Italy by: Sorin Group Italia S.r.l. Via Crescentino s.n. 13040 Saluggia (VC) - Italy Tel: +39 0161 487095 Facsimile: +39 0161 487524 www.sorin.com Distributed by: Sorin CRM USA, Inc. 14401 West 65th Way Arvada, CO 80004 USA Tel: 877.663.
