sorin Intensia DR 154 Implant Manual
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sorin Intensia DR 154 Implant Manual

Implantable cardioverter defibrillator
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Implant manual
Implantable cardioverter defibrillator
DR model 154

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Summary of Contents for sorin Intensia DR 154

  • Page 1 Implant manual Implantable cardioverter defibrillator DR model 154...
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  • Page 5: Table Of Contents

    14.7. Choosing the type of lead.......................34 14.8. Shock configuration (+ -> -).....................35 14.9. Measurement of thresholds at implant..................35 14.10.Lead connection ........................36 14.11. Device implantation.........................37 14.12.Tests and programming......................37 Special modes........................38 15.1. Safety mode (nominal values)....................38 SORIN – INTENSIA DR 154 – U152A...
  • Page 6 20.3. Ventricular tachyarrhythmia therapies..................54 20.4. Remote alerts and warnings....................57 Non programmable parameters...................59 Limited warranty........................60 22.1. Article 1 : Terms of limited warranty..................60 22.2. Article 2 : Terms of replacement....................61 Patents........................... 62 Explanation of symbols......................63 SORIN – INTENSIA DR 154 – U152A...

  • Page 7: General Description

    INTENSIA DR 154 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 DR 154 provides high energy shocks (42 J) for enhanced safety, as well as automatic lead measurements to monitor system integrity.

  • Page 8: Indications

    2. INDICATIONS 2. INDICATIONS INTENSIA DR 154 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, ─...

  • Page 9: Contraindications

    3. CONTRAINDICATIONS 3. CONTRAINDICATIONS Implantation of INTENSIA DR 154 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 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 disturbances caused by electric hand tools or electric razors used directly over the device implant site. SORIN – INTENSIA DR 154 – U152A...

  • Page 11: Risks Related To Medical Environment

    4. After the procedure, check for proper implant function. The device should never be exposed directly to the diathermy source. External defibrillation: INTENSIA DR 154 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 DR 154 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 DR 154 has one IS-1, and one DF-4 connector ports. IS-1 refers to the international standard whereby leads and generators from different manufacturers are assured a basic fit (ISO 5841-1:2000).

  • 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 DR 154 – U152A...

  • Page 15: Adverse Events

    Clinical data presented in this section are from the Defender and SafeR (AAI <> DDD) clinical studies. INTENSIA DR 154 is similar in design and function to the Defender devices.SafeR (AAI <> DDD) operation in INTENSIA is similar to that in the Symphony pacemaker.

  • Page 16: Safer (Aai <> Ddd) Study

    Table 1: Summary of Symphony safety data during study Patients Number of events Number of % of patients Number of Events per patients events device year Deaths Explants Serious pacemaker related events outside the use of SafeR (AAI <> DDD) SORIN – INTENSIA DR 154 – U152A...
  • Page 17 EGM, atrial pacing above the maximum rate, recycling on an R-wave in a refractory period, and disagreement in the statistics for switches to DDD. No patient symptoms were associated with these events. SORIN – INTENSIA DR 154 – U152A...

  • Page 18: Clinical Studies

    Clinical data presented in this section are from the Defender and SafeR (AAI <> DDD) clinical studies. INTENSIA DR 154 is similar in design and function to the Defender devices.SafeR (AAI <> DDD) operation in INTENSIA is similar to that in the Symphony pacemaker.
  • Page 19 CI: Confidence Interval 6.1.3 . Adverse events Event US (N=22) Number of events* Number of patients Percent of patients Intent to treat but did Non-device related death Explant Complication Observation Serious non-related other than death SORIN – INTENSIA DR 154 – U152A...

  • Page 20: Safer (Aai <> Ddd) Study

    ─ During atrial fibrillation episode, pause criterion is fixed to 2s to avoid long bradycardia episodes in switching to DDD mode. Despite these differences, the data collected on Symphony devices are applicable to INTENSIA because the principles of SafeR (AAI <> DDD) operation did not change. The SORIN – INTENSIA DR 154 – U152A...
  • Page 21 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 22 SafeR (AAI <> DDD) Non-serious 28.9 events related due to the use SafeR (AAI <> DDD) Serious non- 13.3 pacemaker related events Non-serious non- 17.8 pacemaker related events 4.74 device years SORIN – INTENSIA DR 154 – U152A...
  • Page 23 EGM, atrial pacing above the maximum rate, recycling on an R-wave in a refractory period, and disagreement in the statistics for switches to DDD. No patient symptoms were associated with these events. SORIN – INTENSIA DR 154 – U152A...

  • Page 24: 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 DR 154 – U152A...

  • Page 25: 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 DR 154 – U152A...

  • Page 26: 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 DR 154 – U152A...

  • Page 27: 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 DR 154 – U152A...
  • Page 28 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 29 400,150-406,000 MHz, et il doit accepter tout brouillage reçu, y compris le brouillage pouvant entraîner un mauvais fonctionnement du dispositif. SORIN – INTENSIA DR 154 – U152A...

  • Page 30: 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 31: 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 32: 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 33: Device Description

    The INTENSIA DR 154 can serve as a defibrillation electrode (active housing) with a total surface area of 76 cm². The INTENSIA DR 154 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 34 Remote Monitoring: INTENSIA DR 154 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 – INTENSIA DR 154 – U152A...

  • Page 35: Implant Procedure

    PACKAGING 14.2.1 . Contents The INTENSIA DR 154 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 36: 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 37: Shock Configuration (+ -> -)

    In the opposite, DF-4 standard compliant lead is not compatible with DF-1 connector. In case of defibrillator replacement and use of a DF-1 lead or any other lead type that require an adaptor for this device, please contact your Sorin representative for any information on lead / connector compatibility question.

  • Page 38: Lead Connection

    (see figure below). 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. SORIN – INTENSIA DR 154 – U152A...

  • Page 39: Device Implantation

    14.11. DEVICE IMPLANTATION INTENSIA DR 154 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 40: 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 DR 154 – U152A...

  • Page 41: 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 DR 154 – U152A...

  • Page 42: Main Functions

    16.4. PACING BTO (Brady Tachy Overlap): Corrects chronotropic atrial incompetence by allowing pacing in the slow VT zone, without affecting arrhythmia detection specificity. SORIN – INTENSIA DR 154 – U152A...

  • Page 43: Sensing

    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. Diagnosis of AV conduction: Automatic diagnosis of AV conduction with graphic displays. SORIN – INTENSIA DR 154 – U152A...

  • Page 44: Remote Monitoring Function

    The data transmitted are identical to the data available during a standard interrogation with the dedicated programmer. All counters, histograms, IEGMs and diagnosis available in the device are transmitted containing (not exhaustive list): ─ programmed parameters ─ Information on patient and system implanted SORIN – INTENSIA DR 154 – U152A...
  • Page 45 ─ AF occurrence ─ Fast V rate during 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 DR 154 – U152A...

  • Page 46: Patient Follow-Up

    The Holter records up to 14 tachyarrhythmia episodes as well as the therapy history. Stored Episodes INTENSIA DR 154 stores up to 14 episodes (VF, VT, Slow VT, SVT/ST, non-sustained). For each episode four levels of details are presented: ─ Tachogram (to visualize PP and PR intervals) ─...

  • Page 47: 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 DR 154 records the type of majority rhythm, the number of ATP sequences delivered, the energy and the number of shocks delivered.

  • Page 48: 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 49: Physical Characteristics

    76 cm Connector Atrium: IS-1. Ventricle: DF-4. 18.1. 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 DR 154 – U152A...

  • Page 50: 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. 19.2. BATTERY Manufacturer Greatbatch Type Quasar High Rate (QHR) Model GB 2593 Number of batteries SORIN – INTENSIA DR 154 – U152A...

  • Page 51: 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 DR 154 – U152A...

  • Page 52: Programmable Parameters

    (± 19 ms) AVD Paced/Sensed Offset (ms) 0-10-15-25-30-40-45-55-65-70-80-85-95-100-110-115-125 (± 1 ms) (1) The corresponding periods are (in ms): 2000-1714-1500-1333-1200-1091-1000-923-857-800-750- 706-667 ms. Special features Values Smoothing OFF-Very slow-Slow-Medium-Fast Mode Switch ON-OFF Physical activity Very low-Low-Medium-High-Very high SORIN – INTENSIA DR 154 – U152A...
  • Page 53 5.25 Ventricular arrhythmia algorithms Values Atrial pacing on PVC Yes-No Post extrasystolic pause suppression Yes-No Acceleration on PVC Yes-No Max acceleration rate (bpm) From 60 to 145 by steps of 5 ; 100 SORIN – INTENSIA DR 154 – U152A...
  • Page 54 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. pause (s) 2-3-4 SORIN – INTENSIA DR 154 – U152A...

  • Page 55: Ventricular Tachyarrhythmia Detection

    Window of RR stability for fast VT 30-45-65 (ms) Acceleration (%) 6-13-19-25-31-38-44-50 Long cycle persistence extension From 0 to 16 by steps of 1 ; 10 (cycles) Long cycle gap (ms) 15-30-45-65-80-95-110-125-140-155-170-190-205 Atrial monitoring Yes-No SORIN – INTENSIA DR 154 – U152A...

  • Page 56: Ventricular Tachyarrhythmia Therapies

    Cycles in first sequence 1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 Cycles added per sequence 0-1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 Coupling interval (%) 50-55-60-65-70-75-80-85-90-95 Ramp decrement (per cycle) (ms) 0-4-8-12-16-20-30-40-50-60 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 SORIN – INTENSIA DR 154 – U152A...
  • Page 57 Cycles in first sequence 1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 Cycles added per sequence 0-1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 Coupling interval (%) 50-55-60-65-70-75-80-85-90-95 Ramp decrement (per cycle) (ms) 0-4-8-12-16-20-30-40-50-60 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 SORIN – INTENSIA DR 154 – U152A...
  • Page 58 Cycles in first sequence 1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 Cycles added per sequence 0-1-2-3-4-5-6-7-8-9-10-11-12-13-14-15 Coupling interval (%) 50-55-60-65-70-75-80-85-90-95 Ramp decrement (per cycle) (ms) 0-4-8-12-16-20-30-40-50-60 Scan decrement (per sequence) (ms) 0-4-8-12-16-20-30-40-50-60 Time limit 10s-20s-30s-1min-1.5min-2min Minimum cycle length (ms) 95-110-125-140-155-170-190-205-220-235-250-265-280- 295-310 SORIN – INTENSIA DR 154 – U152A...

  • Page 59: Remote Alerts And Warnings

    Abnormal V lead low limit (Ohm) 200-250-300-350-400-450-500 Abnormal V lead high limit (Ohm) 1500-1750-2000-2500-3000 Abnormal RV coil impedance ON-OFF Abnormal SVC coil impedance ON-OFF Abnormal Shock impedance ON-OFF (1) Normal impedance range [20 Ohm-200 Ohm] SORIN – INTENSIA DR 154 – U152A...
  • Page 60 AT/AF limit (on 24h) (h) 0.5-1-3-6-12-24 Fast V Rate during AT/AF ON-OFF Fast V Rate limit (bpm) 80-90-100-110-120 Fast V Duration limit (h) 0.5-1-3-6-12-24 Therapy information Values Shock disabled ON-OFF Shocks delivered OFF-All shocks-Inefficient shock-Inefficient max shock SORIN – INTENSIA DR 154 – U152A...

  • Page 61: 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 DR 154 – U152A...

  • Page 62: 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 63: 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 64: 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 DR 154 – U152A...

  • Page 65: 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 : YSGDR154 IC : 10270A-DR154 Last revision date of this implant manual: 2013-09 SORIN – INTENSIA DR 154 – U152A...
  • Page 66 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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