sorin PLATINIUM SonR CRT-D 1811 Implant Manual
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sorin PLATINIUM SonR CRT-D 1811 Implant Manual

Implantable cardioverter defibrillator with cardiac resynchronization therapy
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Implantable cardioverter defibrillator
with cardiac resynchronization therapy
SonR CRT-D models
Implant manual

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Summary of Contents for sorin PLATINIUM SonR CRT-D 1811

  • Page 1 Implantable cardioverter defibrillator with cardiac resynchronization therapy SonR CRT-D models Implant manual...
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  • Page 5: Table Of Contents

    14.7. Choosing the type of lead.......................32 14.8. Shock configuration (+ -> -).....................33 14.9. Measurement of thresholds at implant..................34 14.10.Leads connection........................34 14.11. Device implantation.........................36 14.12.Tests and programming......................36 Special modes........................37 15.1. Safety mode (nominal values)....................37 SORIN – PLATINIUM SonR CRT-D – U463A...
  • Page 6 20.2. Battery............................. 52 20.3. Longevity..........................53 Programmable parameters....................55 21.1. Antibradycardia pacing......................55 21.2. Ventricular tachyarrhythmia detection..................60 21.3. Ventricular tachyarrhythmia therapies..................61 21.4. Remote alerts and warnings....................64 Non programmable parameters...................66 Limited warranty........................67 Patents........................... 68 Explanation of symbols......................69 SORIN – PLATINIUM SonR CRT-D – U463A...

  • Page 7: General Description

    PLATINIUM SonR CRT-D is also equipped with the RF wireless technology which enables: ─ Remote monitoring of patients who have the Sorin SMARTVIEW Monitor installed at home, ─ wireless interrogation and device programming by Orchestra Plus programmer equipped with ORCHESTRA PLUS LINK accessory.

  • Page 8: Indications

    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. SORIN – PLATINIUM SonR CRT-D – U463A...

  • Page 9: Contraindications

    ─ who present incessant tachyarrhythmia, ─ who have an internal pacemaker, ─ whose primary disorder is bradyarrhythmias, or atrial tachyarrhythmias. The use of the dual-chamber pacing mode is contraindicated in patients with chronic refractory atrial tachyarrhythmias. SORIN – PLATINIUM SonR CRT-D – U463A...

  • Page 10: Warnings And Precautions

    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. SORIN – PLATINIUM SonR CRT-D – U463A...

  • Page 11: Risks Related To Medical Environment

    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. SORIN – PLATINIUM SonR CRT-D – U463A...

  • Page 12: Sterilization, Storage And Handling

    A "Use Before" date is printed on the outer storage package and on the sterile package. Do not implant the device after this date because the battery may have reduced longevity and sterility may be affected. It should be returned to Sorin. If Package is damaged: Do not use the device or accessories if the packaging is wet, punctured, opened or damaged because the integrity of the sterile packaging may be compromised.

  • Page 13: Lead Evaluation And Lead Connection

    4.4. LEAD EVALUATION AND LEAD CONNECTION PLATINIUM SonR CRT-D 1811 has two DF-1, two IS-1, and one SonR connector ports. The SonR connector port has been specifically designed by Sorin to accept three connections (tripolar). The two distal connections respect the same dimensions as the IS-1 standard, and an additional proximal connection allows to collect the SonR signal.

  • 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 – PLATINIUM SonR CRT-D – U463A...

  • Page 15: Adverse Events

    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. A total of 182 patients received study devices and had an exposure of over 165 device years.

  • 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 – PLATINIUM SonR CRT-D – U463A...
  • 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 – PLATINIUM SonR CRT-D – U463A...

  • 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 75.6 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 – PLATINIUM SonR CRT-D – U463A...
  • 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 – PLATINIUM SonR CRT-D – U463A...
  • 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 – PLATINIUM SonR CRT-D – U463A...

  • 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 – PLATINIUM SonR CRT-D – U463A...

  • 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 – PLATINIUM SonR CRT-D – U463A...

  • 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 – PLATINIUM SonR CRT-D – U463A...

  • Page 25: Declaration Of Conformity

    9. DECLARATION OF CONFORMITY 9. DECLARATION OF CONFORMITY 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 26 400,150-406,000 MHz, et il doit accepter tout brouillage reçu, y compris le brouillage pouvant entraîner un mauvais fonctionnement du dispositif. SORIN – PLATINIUM SonR CRT-D – U463A...

  • Page 27: 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 28: 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 – PLATINIUM SonR CRT-D – U463A...

  • Page 29: 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. 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 30: How Supplied

    The PLATINIUM 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 31: Device Description

    13. DEVICE DESCRIPTION The PLATINIUM SonR CRT-D 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.
  • Page 32 Remote Monitoring: PLATINIUM SonR CRT-D is also equipped with the RF wireless technology which enables to remotely monitor the patients who have the Sorin SMARTVIEW Monitor installed at home. SORIN – PLATINIUM SonR CRT-D – U463A...

  • Page 33: Implant Procedure

    14.1. NECESSARY EQUIPMENT Implantation of PLATINIUM SonR CRT-D requires the following equipment: ─ Sorin ORCHESTRA programmer, equipped with the SMARTVIEW software interface and inductive telemetry head, ─ Sorin ORCHESTRA PLUS programmer, equipped with the SMARTVIEW software interface, inductive telemetry head and optionally ORCHESTRA PLUS LINK, ─...

  • Page 34: 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 35: Shock Configuration (+ -> -)

    In case of defibrillator replacement, choose the appropriate device compatible with DF-1 or DF4 leads. For any other lead type that requires an adaptor for this device, please contact your Sorin representative for any information on lead / connector compatibility question.

  • Page 36: Measurement Of Thresholds At Implant

    5. Insert the lead pin all the way into the port (check that the pin protrudes beyond the distal insert). SORIN – PLATINIUM SonR CRT-D – U463A...
  • Page 37 In the case of an external defibrillation shock delivered to the patient, always check the programming and functioning of the device, in particular its capacity to deliver shocks. SORIN – PLATINIUM SonR CRT-D – U463A...

  • Page 38: Device Implantation

    Program 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 electrodes, the device can deliver a very high energy shock. SORIN – PLATINIUM SonR CRT-D – U463A...

  • Page 39: 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: For DF-1 models: SORIN – PLATINIUM SonR CRT-D – U463A...
  • Page 40 27.5.1 of standard EN 45502-2-2 for frequencies below 200 Hz. For ventricular sensitivity settings below 0.6mV, the ICD may detect noise lower than the level specified in clause 27.5.1 of standard EN 45502-2-2 for frequencies below 200 Hz. SORIN – PLATINIUM SonR CRT-D – U463A...

  • Page 41: Protection Against Short-Circuits

    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 – PLATINIUM SonR CRT-D – U463A...

  • Page 42: Main Functions

    VT zone. Polarity alternation on Max shock: Reverses the programmed polarity of every second shock set at maximum energy. The number, type, and energy of shocks is independently programmable by detection zone. SORIN – PLATINIUM SonR CRT-D – U463A...

  • Page 43: Pacing

    QRS waves. The device automatically adjusts the sensitivities based on the ventricular sensing amplitude. In case of arrhythmia suspicion or after a paced event, the programmed ventricular sensitivity will be applied. The minimum ventricular sensitivity threshold is 0.4 mV (minimum programmable value). SORIN – PLATINIUM SonR CRT-D – U463A...

  • Page 44: Sonr Crt Optimization

    Regular transmissions are done during the night when the patient is asleep next to the SMARTVIEW monitor without any intervention from the patient. SORIN – PLATINIUM SonR CRT-D – U463A...
  • Page 45 ─ Inefficient high energy shock ─ All shocks programmed OFF ─ Shock treated VT/VF ─ ATP treated VT/VF ─ Lack of V pacing in CRT device ─ Suspicion of noise on the V lead SORIN – PLATINIUM SonR CRT-D – U463A...
  • Page 46 ─ Excessive charge time (>25s) ─ System integrity 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 – PLATINIUM SonR CRT-D – U463A...

  • Page 47: Patient Follow-Up

    Can / RV ring – Can / LV tip – Can / LV ring – Can: ─ Up to 10 episodes and 5 min EGM on significant events: AV block switch, lead impedance out of range. ─ Up to 16 tachyarrhythmia episodes as well as the therapy history. SORIN – PLATINIUM SonR CRT-D – U463A...

  • Page 48: Recommended Replacement Time (Rrt)

    (2) End of Service (EOS) corresponds to End of Life (EOL) previously used. (3) Beginning of Service (BOS) corresponds to Beginning of Life (BOL) previously used. 17.4. EXPLANTATION The defibrillator should be explanted in the following cases: SORIN – PLATINIUM SonR CRT-D – U463A...

  • Page 49: Defibrillator Identification

    ─ Cremation of the patient (the defibrillator may explode if placed in an incinerator) The explanted defibrillator should not be reused in another patient. All explanted defibrillators should be returned to Sorin, carefully cleaned of all traces of contamination. Cleaning may be done by immersing them in an aqueous sodium hypochlorite containing at least 1% chlorine, followed by rinsing copiously with water.

  • Page 50: Supplemental Information

    Non-serious events due to the use of SafeR 2 (AAI <> DDD) included: delay in switching on 2nd degree AV block, inappropriate classification of a PAC, disagreement between markers and recorded EGM, atrial pacing above the maximum rate, recycling on an R-wave in a SORIN – PLATINIUM SonR CRT-D – U463A...

  • Page 51: 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 52 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 – PLATINIUM SonR CRT-D – U463A...

  • Page 53: Physical Characteristics

    Left ventricle: IS-1 bipolar (unipolar compatible). 19.1. MATERIALS USED 99% pure titanium Active surface area of casing Polyurethane* and silicone elastomer* Connectors *Medical-grade materials that have undergone "in vitro" and "in vivo" qualifications. SORIN – PLATINIUM SonR CRT-D – U463A...

  • Page 54: Electrical Characteristics

    Delivered E: Total (J) 17.4 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 3070 Number of batteries SORIN – PLATINIUM SonR CRT-D – U463A...

  • Page 55: Longevity

    12.2 Longevity projection at 600 Ω pacing impedance: A pacing (%) BiV pacing (%) A, RV Pacing amplitude LV Pacing amplitude (V) Sensor Max shocks (42J) per year Longevity (years) 11.6 10.0 12.2 SORIN – PLATINIUM SonR CRT-D – U463A...
  • Page 56 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 – PLATINIUM SonR CRT-D – U463A...

  • Page 57: Programmable Parameters

    Special features Values Rate smoothing OFF-Very slow-Slow-Medium-Fast Mode Switch ON-OFF Physical activity Very low-Low-Medium-High-Very high Exercise AV opt. rate (ppm) From 70 to 120 by steps of 5 ; 90 CRT optimization OFF-Monitor-AV-AV+VV SORIN – PLATINIUM SonR CRT-D – U463A...
  • Page 58 0,35* 0,39 0,33 0,50* 0,52 0,44 0,60* 0,72 0,61 0,75* 0,85 0,72 0,85* 0,98 0,83 1,00 1,11 0,94 1,10* 1,24 1,05 1,25* 1,37 1,16 1,35* 1,50 1,27 1,50 1,63 1,38 1,60* 1,76 1,49 SORIN – PLATINIUM SonR CRT-D – U463A...
  • Page 59 4,25* 4,43 3,75 4,35* 4,56 3,86 4,50 4,69 3,97 4,60* 4,82 4,08 4,75* 4,95 4,19 4,85* 5,08 4,30 5,00 5,25 4,44 5,10* 5,34 4,52 5,25* 5,47 4,63 5,35* 5,60 4,74 5,50* 5,73 4,85 SORIN – PLATINIUM SonR CRT-D – U463A...
  • Page 60 * For left ventricular amplitude only. Ventricular arrhythmia algorithms Values Atrial pacing on PVC Yes-No Post extrasystolic pause suppression Yes-No Acceleration on PVC Yes-No Max acceleration rate (ppm) From 60 to 145 by steps of 5 ; 100 SORIN – PLATINIUM SonR CRT-D – U463A...
  • Page 61 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 Response to noise Values Automatic sensitivity on noise ON-OFF V pacing on noise ON-OFF SORIN – PLATINIUM SonR CRT-D – U463A...

  • Page 62: Ventricular Tachyarrhythmia Detection

    VF rate (lower limit) (ppm) 150-155-160-165-170-175-180-185-190-195-200-210-220- 230-240 Fast VT rate (upper limit) (ppm) 155-160-165-170-175-180-185-190-195-200-210-220-230- 240-255 Slow VT persistence (cycles) 4-6-8-12-16-20-30-50-100-200 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 SORIN – PLATINIUM SonR CRT-D – U463A...

  • Page 63: Ventricular Tachyarrhythmia Therapies

    Atrial coil (SVC) present 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 – PLATINIUM SonR CRT-D – U463A...
  • Page 64 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 – PLATINIUM SonR CRT-D – U463A...
  • Page 65 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 – PLATINIUM SonR CRT-D – U463A...

  • Page 66: 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 – PLATINIUM SonR CRT-D – U463A...
  • Page 67 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 ATP delivered ON-OFF SORIN – PLATINIUM SonR CRT-D – U463A...

  • Page 68: 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 – PLATINIUM SonR CRT-D – U463A...

  • Page 69: Limited Warranty

    The PLATINIUM implantable cardioverter defibrillator is the result of highly advanced research and all components have been selected after exhaustive testing. The terms of the limited warranty are available upon request from your Sorin representative or on the CD-ROM of the package content.

  • Page 70: Patents

    400 922, 7 953 483, US8064992, US8043225, US7792582, US8798748, US7890168, US8195293, US7966068, US8768464, US8874209, US8554313, US8214036, US8233981, US8554319, US7966065, US8253279, US8874210, US8219193, US8391976, US8855764, US8359096, US8494629, US8359091, US8489188, US8712526, US8862230, US8641436, US8718765, US8798771, US8868170, US8678843 , US8694098, US8938286, US8874212. SORIN – PLATINIUM SonR CRT-D – U463A...

  • Page 71: Explanation Of Symbols

    Plus programmer equipped with ORCHESTRA PLUS LINK accessory Do not use if the package is DF-1 defibrillating connector damaged insulating plug Do not reuse Do not resterilize Sterilised using ethylene oxide Non sterile SORIN – PLATINIUM SonR CRT-D – U463A...
  • Page 72 Carefully read the instructions provided with this icon. Eucomed / Advamed Code of Ethical Business Practice Last revision date of this implant manual: 2015-03 SORIN – PLATINIUM SonR CRT-D – U463A...
  • Page 73 2015-03 U463A © 2015 Sorin CRM SAS...

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