Implant manual Implantable cardioverter defibrillator VR model 124
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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...............
15.4. Detection characteristics in the presence of electromagnetic fields........................................35 15.5. Protection against short-circuits..............................................................................................35 16. 16.1. 16.2. 16.3. 16.4. 16.5. 16.6. Main functions....................................................................................................................... 36 Automatic lead measurements.......................................................
1. GENERAL DESCRIPTION 1. GENERAL DESCRIPTION INTENSIA VR 124 is an implantable single-chamber cardioverter defibrillator. It is equipped with an accelerometer to allow adaptation of pacing to suit the patient’s activity. INTENSIA 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.
2. INDICATIONS 2. INDICATIONS INTENSIA VR 124 is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of 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 ventricular tachycardia (VT). NOTE: The clinical outcome for hemodynamically stable VT patients is not fully known.
3. CONTRAINDICATIONS 3. CONTRAINDICATIONS Implantation of INTENSIA VR 124 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 CAUTION: Do not tap sharply on the ICD can after implant, because the ICD's sensing circuits can detect this as 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 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 damage 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.
4. WARNINGS AND PRECAUTIONS In situations where an ICD and a pacemaker are implanted in the same patient, interaction testing should be completed. If the interaction between the ICD and the pacemaker cannot be resolved through repositioning of the leads or reprogramming of either the pacemaker or the ICD, the pacemaker should not be implanted (or should be explanted if previously implanted).
4. WARNINGS AND PRECAUTIONS Do not place the patch lead over nerve tissue as this may cause nerve damage. Place the patch lead with the conducting coil side facing the heart to ensure delivery of energy 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 using external paddles, adjust the external paddle position (e.g.
5. ADVERSE EVENTS 5. ADVERSE EVENTS Clinical data presented in this section are from the Defender study. INTENSIA VR 124 is similar in design and function to the Defender devices. The data provided are applicable to INTENSIA VR 124. 5.1. DEFENDER STUDY Clinical study of Defender IV DR 612 included 60 devices implanted in 60 patients, 38 in Europe (37 patients followed for a minimum of 3 months), and 22 in the U.S. (IDE G970282/S15) with a total device exposure of 228.7 and 30.
5. ADVERSE EVENTS Event # of Patients* % of Patients # of Events Events/100 DeviceYears** Change in ventricular 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 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 Prolonged implant procedure 1 2.6 1 5.2 Sensor acceleration during telemetry*** 1 2.6 1 5.
6. CLINICAL STUDIES 6. CLINICAL STUDIES Clinical data presented in this section are from the Defender study. INTENSIA VR 124 is similar in design and function to the Defender devices. The data provided are applicable to INTENSIA VR 124. 6.1.
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 Lower 95% slope %SRR CI on %MR Upper 95% CI Europe 20 0.77 0.17 0.04 0.69 0.
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.
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 YSGVR124. 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 implant procedure and familiar with follow-up evaluation and management of patients with an implantable defibrillator (or referral to such a physician). 10.2. DIRECTIONS FOR USE ICD operating characteristics should be verified at the time of implantation and recorded in the patient file.
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 VR system includes the model 124 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 VR 124 can serve as a defibrillation electrode (active housing) with a total surface area of 76 cm².
13. DEVICE DESCRIPTION ─ Capacitor charge time, ─ Pacing threshold tests. ─ Data storage: ─ Therapy History Report, ─ Statistics (pace/sense, therapy, shocks, and battery voltage), ─ Up to 14 complete Holter records with event logs, marker channel notation, and electrogram records. The connector head has one port: ventricular bipolar pace/sense and RV & SVC defibrillation coils. The defibrillation port is compatible with the DF-1 standard.
14. IMPLANT PROCEDURE 14. IMPLANT PROCEDURE 14.1.
14. IMPLANT PROCEDURE Interrogate the device: ─ if a warning is displayed, do not implant the device and contact your Sorin representative. ─ if magnet rate is lower than 91 min-1, and if the last reforming/charge occurred more than one week ago, do not implant the device. Otherwise wait for one more week before checking the magnet rate again. NOTE : The magnet rate and battery voltage can decrease before the expiration date is reached.
14. IMPLANT PROCEDURE Connectors: The quadripolar connector is compatible with the DF-4 standard (refer to the “Lead evaluation and lead connection” sub-section in the “Warnings and precautions” section). 14.8. SHOCK CONFIGURATION (+ -> -) The shock configuration is the energy pathway between the defibrillation electrodes. If an atrial coil is present, the shock configuration can be programmed for bi-directional shocks.
14. IMPLANT PROCEDURE To connect the lead, proceed as follows: 1. Clean the lead terminal pins thoroughly, if necessary (device replacement). 2. Lubricate the lead terminal pins with sterile water, if necessary. 3. Do not insert a lead connector pin into the connector block without first visually verifying that the lead port is not filled with any obstacle. 4.
14. IMPLANT PROCEDURE NOTE: To optimize cardioversion/defibrillation shocks, electrodes must be positioned so that the electric field between anode(s) and cathode covers the largest myocardial mass. In normal conditions, the anode and cathode are adequately separated. In case of a shortcircuit, the shock may be aborted to prevent damaging the defibrillator.
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: 15.5. ─ Differential mode: ─ Common mode rejection ratio: 16.
16. MAIN FUNCTIONS 16. MAIN FUNCTIONS 16.1. AUTOMATIC LEAD MEASUREMENTS Automatic pacing lead impedance measurement: A lead impedance measurement is automatically performed on the lead every 6 hours. The daily mean impedance is stored. 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 Protection against noise: Allows the distinction between ventricular noise and ventricular fibrillation. If the device senses ventricular noise, the ventricular sensitivity is decreased until noise is no longer detected. Ventricular pacing can be inhibited to avoid a potential paced T-wave. Automatic sensitivity control: Optimizes arrhythmia detection and avoids late detection of T-waves and over-detection of wide QRS waves.
16. MAIN FUNCTIONS done during the night when the patient is asleep next to the SMARTVIEW monitor without any intervention from the patient. 16.6.2 . Transmission trigger There are 3 different triggers for a remote transmission: ─ the remote follow-up transmission is scheduled by the physician to occur regularly (according to the programming). ─ the alert transmission will take place when the implant has recorded an abnormal event. The list of abnormal event is available in a following paragraph.
16. MAIN FUNCTIONS ─ Suspicion of noise on the V lead WARNING: The use of remote monitoring does not replace regular follow-up. Therefore, when using remote monitoring, the time period between follow-ups visits may not be extended.
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: Ventricular 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 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. ─ print out all programmed parameters, statistics and Holter function report, ─ save Patient data on floppy disk or hard disk, ─ disable shock therapies (VT and VF) to avoid any risk of untimely shock.
18. PHYSICAL CHARACTERISTICS 18. PHYSICAL CHARACTERISTICS 18.1. Dimensions 61.9 x 73.4 x 11 mm Weight 92 g Volume 38.6 cm3 Active surface area of casing 76 cm2 Connector DF-4 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.
19. ELECTRICAL CHARACTERISTICS 19. ELECTRICAL CHARACTERISTICS 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 19.1.
19. ELECTRICAL CHARACTERISTICS 19.3. 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. 7.3 years Pacing in VVI mode, 100%, 500 ohm, 3.5 V, 0.35 ms, 60 bpm, one 42 J shock per quarter, sensor OFF 7.1 years Pacing in VVI mode, 100%, 500 ohm, 3.5 V, 0.35 ms, 60 bpm, one 42 J shock per quarter, sensor ON 9.
20. PROGRAMMABLE PARAMETERS 20. PROGRAMMABLE PARAMETERS measured at 37 °C under a 500 ohm load Legend: Value in bold: "as shipped" value Underlined value: nominal value 20.1.
20. PROGRAMMABLE PARAMETERS 20.2. Post-shock mode Values Mode OFF-VVI Duration 10s-20s-30s-1min-2min-3min-4min-5min Basic rate (bpm) From 50 to 90 by steps of 5 ; 60 (± 4 %) V amplitude (V) 1-1.5-2-2.5-3-3.5-4-4.5-5-6 (± 20 %) V pulse width (ms) 0.12-0.25-0.35-0.5-0.6-0.75-0.85-1 (± 10 %) Sensitivity margins Values Ventricular post pacing margin (mV) From 0 to 2 by steps of 0.2 ; 0.
20. PROGRAMMABLE PARAMETERS 20.3.
20. PROGRAMMABLE PARAMETERS 20.3.1 .
20. PROGRAMMABLE PARAMETERS 20.3.2 .
20. PROGRAMMABLE PARAMETERS 20.3.3 .
20.
21. NON PROGRAMMABLE PARAMETERS 21. NON PROGRAMMABLE PARAMETERS Ventricular refractory periods Values Post ventricular sensing 95 ms (± 16 ms) 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 device has 50% tilt in each phase thus delivers 94% of stored energy. Each phase is limited to 10 ms duration.
22. LIMITED WARRANTY 22. 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.
22. 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. 22.2. ARTICLE 2 : TERMS OF REPLACEMENT 1.
23. PATENTS 23.
24. EXPLANATION OF SYMBOLS 24. 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.
