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sorin Intensia SonR CRT-D 184 Implant Manual

Implantable cardioverter defibrillator
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Implant manual
Implantable cardioverter defibrillator
SonR CRT-D model 184

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  • Page 1 Implant manual Implantable cardioverter defibrillator SonR CRT-D model 184...
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  • Page 5: Table Of Contents

    14.7. Choosing the type of lead.......................33 14.8. Shock configuration (+ -> -).....................34 14.9. Measurement of thresholds at implant..................34 14.10.Leads connection........................35 14.11. Device implantation.........................36 14.12.Tests and programming......................36 Special modes........................37 15.1. Safety mode (nominal values)....................37 SORIN – INTENSIA SonR CRT-D 184 – U150A...
  • Page 6 21.3. Ventricular tachyarrhythmia therapies..................56 21.4. Remote alerts and warnings....................59 Non programmable parameters...................61 Limited warranty........................62 23.1. Article 1 : Terms of limited warranty..................62 23.2. Article 2 : Terms of replacement....................63 Patents........................... 64 Explanation of symbols......................65 SORIN – INTENSIA SonR CRT-D 184 – U150A...

  • Page 7: General Description

    Sorin SMARTVIEW Monitor installed at home. INTENSIA SonR CRT-D 184 provides high energy shocks (42 J) for enhanced safety, as well as automatic lead measurements to monitor system integrity. INTENSIA SonR CRT-D 184 is protected against high-frequency signals emitted by cellular telephones.

  • Page 8: Indications

    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.

  • Page 9: Contraindications

    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, ─...

  • Page 10: Warnings And Precautions

    Home appliances: Home appliances that are in good working order and properly grounded do not usually produce enough EMI to interfere with defibrillator operation. There are reports of device SORIN – INTENSIA SonR CRT-D 184 – U150A...

  • Page 11: Risks Related To Medical Environment

    External defibrillation: INTENSIA SonR CRT-D 184 is protected from external defibrillation shocks. 1. Before external defibrillation, disable ATP and shock therapies. 2. During external defibrillation, it is advisable to avoid placing the defibrillating paddles directly over the casing or over the leads.

  • Page 12: Sterilization, Storage And Handling

    Diagnostic ultrasound (echography): The defibrillator is not affected by ultrasound imaging devices. Scales with body fat monitors and electronic muscle stimulators: A patient with an implanted INTENSIA SonR CRT-D 184 should not use these devices. 4.2. STERILIZATION, STORAGE AND HANDLING Resterilization: Do not resterilize and re-implant explanted ICDs.

  • Page 13: Lead Evaluation And Lead Connection

    *: corresponds to ERI (Elective Replacement Indicator) previously used. 4.4. LEAD EVALUATION AND LEAD CONNECTION INTENSIA SonR CRT-D 184 has one DF-4, one IS-1, and one SonR connector ports. The SonR connector port has been specifically designed by Sorin to accept three connections (tripolar).

  • Page 14: Generator Explant And Disposal

    Return all explanted generators and leads to the manufacturer. Never incinerate the device due to the potential for explosion. The device must be explanted before cremation. SORIN – INTENSIA SonR CRT-D 184 – U150A...

  • Page 15: 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.

  • Page 16: Potential Adverse Events

    ─ Venous occlusion, ─ Venous or cardiac perforation. Patients susceptible to frequent shocks despite antiarrhythmic medical management may develop psychological intolerance to an ICD system that may include the following: ─ Dependency, ─ Depression, SORIN – INTENSIA SonR CRT-D 184 – U150A...
  • Page 17 5. ADVERSE EVENTS ─ Fear of premature battery depletion, ─ Fear of shocking while conscious, ─ Fear that shocking capability may be lost, ─ Imagined shocking (phantom shock). SORIN – INTENSIA SonR CRT-D 184 – U150A...

  • Page 18: Clinical Studies

    Patients were New York Heart Association class III or IV and had one or more indications for an implantable cardioverter defibrillator (ICD). Patients performed cardiopulmonary exercise testing at baseline and six-months after randomization. Patients were implanted with a Sorin ICD with CRT-D, a Situs UW28D left ventricular lead, and commercially available right atrial and ventricular leads.
  • Page 19 74.7 48.8 67.0 62.2 70.9 % Worsened 24.4 25.3 51.2 31.9 37.8 28.6 Unchanged Histograms for Respiratory Exchange Rate (RER) at peak VO at baseline and 6 month follow-up are provided below: SORIN – INTENSIA SonR CRT-D 184 – U150A...
  • Page 20 Synchronous BiV pacing and V-V delay. The optimization protocol in the clinical study specified that each patient randomized should undergo echo guided V-V optimization. Per the investigational plan for the MSP Clinical SORIN – INTENSIA SonR CRT-D 184 – U150A...
  • Page 21 The CRT-D patients who did not undergo V-V delay optimization showed a smaller improvement in the composite endpoint, although the sample size did not permit conclusions based on data from this subset. SORIN – INTENSIA SonR CRT-D 184 – U150A...

  • Page 22: Patient Selection And Treatment

    Changes in a patient’s antiarrhythmic drug or any other medication that affects the patient’s normal cardiac rate or conduction can affect the rate of tachyarrhythmias and/or efficacy of therapy. Direct any questions regarding the individualization of patient therapy to Sorin’s representative. SORIN – INTENSIA SonR CRT-D 184 – U150A...

  • Page 23: Specific Patient Populations

    Most of the patients receiving this device in clinical studies were over the age of 60 years. Handicapped and Disabled Patients: Special care is needed in using this device for patients using an electrical wheel chair or other electrical (external or implanted) devices. SORIN – INTENSIA SonR CRT-D 184 – U150A...

  • Page 24: Patient Counselling Information

    ─ 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. SORIN – INTENSIA SonR CRT-D 184 – U150A...

  • Page 25: Conformance To Standards

    (frequency range of 30MHz to 6 GHz). This information should not be used as a basis of comparisons among devices since different parts of the standards mentioned may have been used. SORIN – INTENSIA SonR CRT-D 184 – U150A...
  • Page 26 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)
  • Page 27 400,150-406,000 MHz, et il doit accepter tout brouillage reçu, y compris le brouillage pouvant entraîner un mauvais fonctionnement du dispositif. SORIN – INTENSIA SonR CRT-D 184 – U150A...

  • Page 28: Physician Guidelines

    DIRECTIONS FOR USE ICD operating characteristics should be verified at the time of implantation and recorded in the patient file. Complete the Patient Registration Form and return it to Sorin, as it provides necessary information for warranty purposes and patient tracking.

  • Page 29: Programming Recommendation

    V-V PROGRAMMING RECOMMENDATION It is recommended that V-V optimization testing be performed and used to set the V-V delay for this device to optimize the potential for RF SonR CRT-D benefit to the patient. SORIN – INTENSIA SonR CRT-D 184 – U150A...

  • Page 30: 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.

  • Page 31: How Supplied

    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.

  • Page 32: Device Description

    The INTENSIA SonR CRT-D 184 can serve as a defibrillation electrode (active housing) with a total surface area of 76 cm². The INTENSIA SonR CRT-D 184 is designed to recognize and treat slow or fast VT and VF by continuously monitoring atrial and ventricular activity to identify persistent ventricular arrhythmias and to deliver appropriate therapies.
  • Page 33 Remote Monitoring: INTENSIA SonR CRT-D 184 is also equipped with the RF wireless technology which enables to remotely monitor the patients who have the Sorin SMARTVIEW Monitor installed at home.

  • Page 34: Implant Procedure

    PACKAGING 14.2.1 . Contents The INTENSIA SonR CRT-D 184 and its accessories are ethylene oxide sterilized and hermetically sealed in two-ply clear packaging meeting international requirements. The sterile packaging contains a defibrillator and one screwdriver. The non-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.

  • Page 35: Before Opening The Package

    Also check the integrity of the sterile package. The sterility of the contents is no longer guaranteed if the package has been pierced or altered. If the defibrillator is no longer sterile, it should be returned in its packaging to Sorin. Any re-sterilization of the unit is at the discretion of Sorin.

  • Page 36: Shock Configuration (+ -> -)

    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;...

  • Page 37: Leads Connection

    4. One single set screw is located on the side of the connection header. 5. Use only the screwdriver provided with the defibrillator. Maintain the screwdriver's shaft perpendicular to the plane of the defibrillator (see figure below). SORIN – INTENSIA SonR CRT-D 184 – U150A...

  • Page 38: Device Implantation

    14.11. DEVICE IMPLANTATION INTENSIA SonR CRT-D 184 should be implanted with the engraved side facing outwards for optimal communication with the programming head and radiographic identification. Carefully wind excess lead and place in a separate pocket to the side of the defibrillator.

  • Page 39: Special Modes

    The programmed mode is restored as soon as the noise is no longer detected. Ventricular pacing is also inhibited by ventricular noise. It can be restored by setting the parameter V pacing on noise to Yes. SORIN – INTENSIA SonR CRT-D 184 – U150A...

  • Page 40: Detection Characteristics In The Presence Of Electromagnetic Fields

    In this case, the shock is aborted to prevent damaging the defibrillator and a warning will indicate that a short circuit (shock impedance < 20 ohms) was detected during the last shock. SORIN – INTENSIA SonR CRT-D 184 – U150A...

  • Page 41: Main Functions

    16.4. PACING BTO (Brady Tachy Overlap): Enables cardiac resynchronization therapy within the slow VT zone to preserve patient exercise capacity, without affecting detection or treatment of slow VTs. SORIN – INTENSIA SonR CRT-D 184 – U150A...

  • Page 42: Sensing

    The signal picked-up by the SonR sensor can be processed by INTENSIA SonR CRT-D 184 in order to automatically adjust VV delays and AV delays during rest and exercise for optimal resynchronization therapy.

  • Page 43: Follow-Up Function

    The list of abnormal event is available in a following paragraph. Alert conditions are checked daily. ─ the on-demand follow-up transmission is triggered by the patient himself through the use of a specific button on the remote-monitor. SORIN – INTENSIA SonR CRT-D 184 – U150A...
  • Page 44 ─ Fast V rate during AT/AF 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. SORIN – INTENSIA SonR CRT-D 184 – U150A...

  • Page 45: Patient Follow-Up

    The Holter records up to 14 tachyarrhythmia episodes as well as the therapy history. Stored Episodes INTENSIA SonR CRT-D 184 stores up to 14 episodes (VF, VT, Slow VT, SVT/ST, non- sustained). For each episode four levels of details are presented: ─...

  • Page 46: Recommended Replacement Time (Rrt)

    For each arrhythmia detection, each therapy delivered (either automatically or during an electrophysiological study) and at the end of each arrhythmia, INTENSIA SonR CRT-D 184 records the type of majority rhythm, the number of ATP sequences delivered, the energy and the number of shocks delivered.

  • Page 47: Defibrillator Identification

    1. Take an x-ray to identify the name of the manufacturer and model, printed on the device (X-ray ID is SDE : S = SORIN ; D = Defibrillator ; E = INTENSIA range). 2. Interrogate the device using the Sorin dedicated programmer. The model and serial number of the device are automatically displayed.

  • Page 48: 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.

  • Page 49: Safer (Aai <> Ddd) Clinical Study

    SafeR (AAI <> DDD) mode. A variety of marketed atrial and ventricular pacing leads were used. The pacemaker was programmed and interrogated via bi- directional telemetry using a Sorin dedicated programmer and a CPR3 programming head. The study’s routine evaluation consisted of enrollment, pre-discharge evaluation, and a scheduled follow-up visit at one month.
  • Page 50 AV block (49 %), sinus node disease (16 %), brady-tachy syndrome (5 %), AV block + sinus node disease (19 %), AV block + brady-tachy syndrome (6 %), and brady-tachy syndrome + sinus node disease (5 %). SORIN – INTENSIA SonR CRT-D 184 – U150A...

  • Page 51: Physical Characteristics

    Atrium: SonR. Right ventricle: DF-4. Left ventricle: IS-1. 19.1. 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. SORIN – INTENSIA SonR CRT-D 184 – U150A...

  • Page 52: Electrical Characteristics

    Delivered E: Total (J) 17.6 30.0 37.1 Tolerances are 12% for voltage (25% at 0.5 J) and 30% for energy. 20.2. BATTERY Manufacturer Greatbatch Type Quasar High Rate (QHR) Model GB 2593 Number of batteries SORIN – INTENSIA SonR CRT-D 184 – U150A...

  • Page 53: Longevity

    The mean longevity as a function of yearly remote follow-ups , with and without pacing, is as follows: (1) An excessive number of remote follow-ups can have a non-negligible impact on device longevity. SORIN – INTENSIA SonR CRT-D 184 – U150A...

  • Page 54: Programmable Parameters

    Special features Values Smoothing OFF-Very slow-Slow-Medium-Fast Mode Switch ON-OFF Physical activity Very low-Low-Medium-High-Very high Exercise AV opt. rate (bpm) From 70 to 120 by steps of 5 ; 90 CRT optimization OFF-AV+VV SORIN – INTENSIA SonR CRT-D 184 – U150A...
  • Page 55 Stored amplitude (V) 3.58 3.82 3.98 4.20 4.55 4.96 Programmed ampl. (V) 4.75* Mid-pulse delivered 4.36 4.47 5.37 6.26 ampl. (V) Stored amplitude (V) 5.12 5.25 6.30 7.35 * For left ventricular amplitude only. SORIN – INTENSIA SonR CRT-D 184 – U150A...
  • Page 56 Sensitivity margins Values Atrial post pacing/sensing margin From 0 to 1 by steps of 0.2 ; 0.4 (mV) Ventricular post pacing margin (mV) From 0 to 2 by steps of 0.2 ; 0.8 SORIN – INTENSIA SonR CRT-D 184 – U150A...

  • Page 57: Ventricular Tachyarrhythmia Detection

    VT persistence (cycles) 4-6-8-12-16-20-30-50-100-200 VF persistence (cycles) From 4 to 20 by steps of 1 ; 6 (1) The Slow VT zone should be programmed ON only if the VT zone is programmed ON. SORIN – INTENSIA SonR CRT-D 184 – U150A...

  • Page 58: Ventricular Tachyarrhythmia Therapies

    Yes-No Active case Yes-No Shock configuration (+ --> -) Case to RV-SVC to RV-Case + SVC to RV-RV to Case-RV to SVC-RV to Case + SVC SVC exclusion (shock < 15J) Yes-No SORIN – INTENSIA SonR CRT-D 184 – U150A...
  • Page 59 Scan decrement (per sequence) (ms) 0-4-8-12-16-20-30-40-50-60 Time limit (min) 0.5-1-1.5-2-2.5-3-3.5-4 Minimum cycle length (ms) 95-110-125-140-155-170-190-205-220-235-250-265-280- 295-310 Shock program Values Shock 1 (J) OFF-0.5-0.8-1-1.3-1.5-2-2.5-3-3.5-4-5-6-7-8-9- 10-12-14-16-18-20-22-24-26-28-30-32-34-42 Shock 2 (J) OFF-0.5-0.8-1-1.3-1.5-2-2.5-3-3.5-4-5-6-7-8-9- 10-12-14-16-18-20-22-24-26-28-30-32-34-42 Number of Max. Shock (42 J) OFF-1-2-3-4 SORIN – INTENSIA SonR CRT-D 184 – U150A...
  • Page 60 Scan decrement (per sequence) (ms) 0-4-8-12-16-20-30-40-50-60 Time limit (min) 0.5-1-1.5-2-2.5-3-3.5-4 Minimum cycle length (ms) 95-110-125-140-155-170-190-205-220-235-250-265-280- 295-310 Shock program Values Shock 1 (J) OFF-0.5-0.8-1-1.3-1.5-2-2.5-3-3.5-4-5-6-7-8-9- 10-12-14-16-18-20-22-24-26-28-30-32-34-42 Shock 2 (J) OFF-0.5-0.8-1-1.3-1.5-2-2.5-3-3.5-4-5-6-7-8-9- 10-12-14-16-18-20-22-24-26-28-30-32-34-42 Number of Max. Shock (42 J) OFF-1-2-3-4 SORIN – INTENSIA SonR CRT-D 184 – U150A...

  • Page 61: Remote Alerts And Warnings

    (1) RF and Remote alerts are turned on automatically if Shocks are programmed ON. When Alerts are programmed "On", the following System Alerts are automatically activated: ─ Battery depletion – RRT ─ Device reset ─ Excessive charge time (>25s) SORIN – INTENSIA SonR CRT-D 184 – U150A...
  • Page 62 Fast V Duration limit (h) 0.5-1-3-6-12-24 Limited % of V pacing in CRT ON-OFF Limited % of V pacing (%) 50-70-80-85-90-95 Therapy information Values Shock disabled ON-OFF Shocks delivered OFF-All shocks-Inefficient shock-Inefficient max shock SORIN – INTENSIA SonR CRT-D 184 – U150A...

  • Page 63: Non Programmable Parameters

    7 V (Actual value at 300 ms: 5.3 V ) therapies Anti-PMT protection Termin (1) The device has 50% tilt in each phase thus delivers 94% of stored energy. Each phase is limited to 10 ms duration. SORIN – INTENSIA SonR CRT-D 184 – U150A...

  • Page 64: Limited Warranty

    1 and described in article 2 of this section. Sorin makes no claim that the human body will not react unsuitably to the implantation of the INTENSIA device, or that failure will never occur.

  • Page 65: Article 2 : Terms Of Replacement

    ─ or issuing a replacement credit equal to the purchase price for the purchase of any other Sorin replacement device. 2. After a two-year period and up to 4 years after the implantation, Sorin, because of limited warranty terms, will issue a replacement credit to the buyer of an amount equivalent to half of the initial purchase price minus prorata temporis during this two-years period.

  • Page 66: Patents

    912 421, 6 937 898, 6 975 905, 7 065 402, 7 072 716, 7 076 297, 7 113 826, 7 142 924, 7 164 946, 7 251 526, 7 366 566, 7 400 921, 7 400 922, 7 953 483. SORIN – INTENSIA SonR CRT-D 184 – U150A...

  • Page 67: Explanation Of Symbols

    This icon alerts you to a hazard that may result in equipment damage or personal injury. Carefully read the instructions provided with this icon. FCC ID : YSGSONRCRTD184 IC : 10270A-SONRCRTD184 Last revision date of this implant manual: 2013-09 SORIN – INTENSIA SonR CRT-D 184 – U150A...
  • Page 68 CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN Manufactured in Italy by: Distributed by: Sorin Group Italia S.r.l. Sorin CRM USA, Inc. Via Crescentino s.n. 14401 West 65th Way 13040 Saluggia (VC) - Italy...

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