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Excessive fibrotic tissue growth

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Extracardiac stimulation (muscle/nerve stimulation)

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Fluid accumulation

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Foreign body rejection phenomena

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Formation of hematomas or seromas

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Heart block

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Hemorrhage

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Hemothorax

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Inability to defibrillate or pace

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Inappropriate therapy (e.g., shocks and antitachycardia pacing [ATP]
where applicable, pacing)

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Incisional pain

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Incomplete lead connection with pulse generator

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Infection including endocarditis

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Lead dislodgment

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Lead fracture

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Lead insulation breakage or abrasion

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Lead tip deformation and/or breakage

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Local tissue reaction

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Low amplitude VF signals

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Malignancy or skin burn due to fluoroscopic radiation

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Myocardial trauma (e.g., irritability, injury, tissue damage)

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Myopotential sensing

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Oversensing/undersensing

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Pericardial rub, effusion

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Pneumothorax

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Post-shock rhythm disturbances

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Pulse generator and/or lead migration

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Shunting current during defibrillation with internal or external paddles

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Syncope

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Tachyarrhythmias, which include acceleration of arrhythmias and early,
recurrent atrial fibrillation

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Thrombosis/thromboemboli

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Valve damage

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Vasovagal response

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Venous occlusion

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Venous trauma (e.g., perforation, dissection, erosion)

Содержание RELIANCE 4-FRONT Series

Страница 1: ...DF4 LLHO Connectors Tined Fixation Single Shock Coil with Silicone In Fill Model 0650 0662 0663 Dual Shock Coils with Silicone In Fill Model 0651 0636 0665 CAUTION Federal law USA restricts this device to sale by or on the order of a physician trained or experienced in device implant and follow up procedures ...

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Страница 3: ...aque Suture Sleeve 13 Stylets 13 Lead Cap 14 EZ 4 Connector Tool 14 IMPLANTATION 14 Attaching the Connector Tool to the Lead 15 Inserting the Stylet 15 Inserting the Lead 16 Positioning Lead in Right Ventricle 19 Checking for Lead Stability 20 Evaluating Lead Performance 20 Connection to a Pulse Generator 22 Electrical Performance 23 Conversion Testing 23 Securing the Lead 25 Tunneling the Lead 27...

Страница 4: ...UAL COIL models DF4 LLHH connector Tined fixation SINGLE COIL models DF4 LLHO connector Tined fixation 1 Distal steroid eluting pace sense electrode cathode 2 Proximal pace sense coil anode distal defibrillating coil 3 Proximal defibrillating coil dual coil models only 4 Suture sleeve 5 Terminal pin insertion indicator ...

Страница 5: ...L indicates a connection to a low voltage pace sense electrode first L terminal pin distal pace sense electrode second L proximal ring contact proximal pace sense electrode H indicates a connection to a high voltage defibrillation electrode first H middle ring contact distal coil electrode second H distal ring contact proximal coil electrode dual coil models O indicates an inactive distal ring con...

Страница 6: ...ation and single coil models have one conductor for defibrillation The lead conductors are coated and insulated in separate lumens within the silicone rubber lead body A second layer of silicone covers the lead body to provide additional insulation and a uniform body diameter A layer of polyurethane covers the proximal area of the lead body to provide additional abrasion protection in the implanta...

Страница 7: ...bers of MR Conditional pulse generators and components as well as a complete description of the ImageReady MR Conditional Defibrillation System refer to the MRI Technical Guide Implant related MRI Conditions of Use The following subset of the MRI Conditions of Use pertains to implantation and is included as a guide to ensure implantation of a complete ImageReady MR Conditional System For a full li...

Страница 8: ... risk of contamination of the device and or cause patient infection or cross infection including but not limited to the transmission of infectious disease s from one patient to another Contamination of the device may lead to injury illness or death of the patient Backup defibrillation protection Always have external defibrillation equipment available during implant and electrophysiologic testing I...

Страница 9: ... Conditional and should not be brought into the MRI scanner room the control room or the MRI site Zone III or IV areas Separate defibrillation electrode In order to deliver defibrillation therapy the single coil models must be implanted with an additional defibrillation electrode It is recommended to use the pectorally implanted defibrillator pulse generator that uses the metallic housing as a def...

Страница 10: ...tions or complications usually associated with injectable dexamethasone acetate apply to the use of a low concentration highly localized controlled release device Refer to the Physicians Desk Reference 5 for a listing of potentially adverse effects Sterilization and Storage If package is damaged The blister trays and contents are sterilized with ethylene oxide gas before final packaging When the p...

Страница 11: ... connector and or result in potential adverse consequences such as undersensing of cardiac activity or failure to deliver necessary therapy Line powered equipment Exercise extreme caution if testing leads using line powered equipment because leakage current exceeding 10 µA can induce ventricular fibrillation Ensure that any line powered equipment is within specifications Do not bend the lead near ...

Страница 12: ...ls may cause lead damage or patient injury Inaccurate rate counting R wave amplitudes of less than the recommended value can cause inaccurate rate counting in the chronic state possibly resulting in failure to sense a tachyarrhythmia or misdiagnosis of a normal rhythm as abnormal Signal durations that exceed the programmed refractory period of the pulse generator can cause inaccurate rate sensing ...

Страница 13: ...e pulse generator or leads Keep the path of the electrical current as far away as possible from the pulse generator and leads If electrocautery is performed on tissue near the device or leads monitor pre and post measurements for sensing and pacing thresholds and impedances to determine the integrity and stability of the system Use short intermittent and irregular bursts at the lowest feasible ene...

Страница 14: ...ection due to low amplitude VF signals it may be necessary to reposition the lead Lead performance in chronic state For some patients lead performance at implant may not predict performance in the chronic state Therefore it is strongly recommended that post implant follow up EP testing be performed should any change occur in lead performance This testing should include at least one arrhythmia indu...

Страница 15: ...n breakage or abrasion Lead tip deformation and or breakage Local tissue reaction Low amplitude VF signals Malignancy or skin burn due to fluoroscopic radiation Myocardial trauma e g irritability injury tissue damage Myopotential sensing Oversensing undersensing Pericardial rub effusion Pneumothorax Post shock rhythm disturbances Pulse generator and or lead migration Shunting current during defibr...

Страница 16: ...ective Various factors such as disease state or drug therapy may necessitate repositioning of the defibrillation leads or substitution of one lead system for another in order to facilitate arrhythmia conversion In some cases reliable arrhythmia conversion may not be obtained with any leads at the available defibrillation or pulse generator defibrillation energy levels Bipolar pacemakers may be use...

Страница 17: ...e desired position The window feature is designed to aid compression of the sleeve onto the lead during suturing NOTE A radiopaque suture sleeve is pre loaded on the lead and is also available in a slit form as an accessory Model 6403 The accessory slit suture sleeve is intended to be used as a replacement for the pre loaded suture sleeve in the event of damage or loss CAUTION Use of multiple sutu...

Страница 18: ...E Select the appropriate lead length for a given patient It is important to select a lead that is long enough to avoid any sharp angles or kinks and to allow for a gentle curve of excess lead in the pocket Typically a minimum of 5 to 10 cm of excess lead is sufficient to achieve this configuration in the pocket The suture sleeve should be secured to the lead as close to the vascular access site as...

Страница 19: ...r Tool to the proximal end of the lead 1 Indicator arrows 2 Terminal boot molding 3 Terminal molding Figure 2 Lead fully inserted into Connector Tool Inserting the Stylet Follow the steps below to insert a stylet 1 Remove any preinserted stylet before inserting a different one 2 Select a stylet according to the function and to the preferred firmness If desired gently curve the stylet with any ster...

Страница 20: ...ss the right or left cephalic vein in the deltopectoral groove The vein pick packaged with this lead can be used to aid access during the cutdown procedure Isolate the selected vein and introduce the point of the vein pick via this incision into the lumen of the vein With the point of the vein pick facing in the direction of the desired lead passage gently raise and tilt the pick Pass the lead und...

Страница 21: ...or ligamentous structures associated with the narrow costoclavicular region 8 It is recommended to introduce the lead into the subclavian vein near the lateral border of the first rib The syringe should be positioned directly above and parallel to the axillary vein to reduce the chance that the needle will contact the axillary or subclavian arteries or the brachial plexus Use of fluoroscopy is hel...

Страница 22: ...ex finger on the clavicle at the junction of the medial and middle thirds point V beneath which point the subclavian vein should be located 4 Press a thumb against the index finger and project 1 2 centimeters below the clavicle to shield the subclavius muscle from the needle when hypertrophy of the pectoralis muscle is apparent the thumb should project about 2 centimeters below the clavicle becaus...

Страница 23: ... Partially withdraw the stylet during lead positioning to minimize tip stiffness NOTE A curved stylet may enhance maneuverability 2 Under fluoroscopy and with a stylet in the lead advance the lead as far as possible until the tip enters and becomes lodged in healthy myocardium in the apex of the right ventricle WARNING Take care to obtain appropriate electrode position Failure to do so may result ...

Страница 24: ...o 25 cm 2 Check the stability of the lead using fluoroscopy Do not tug on the lead If possible have the patient cough or take several deep breaths 3 When the electrode position is satisfactory withdraw the stylet beyond the right atrium CAUTION Should dislodgment occur immediate medical care is required to resolve the electrode position and minimize endocardial trauma Evaluating Lead Performance V...

Страница 25: ... necessary to obtain a signal with the largest possible amplitude shortest duration and lowest pacing threshold Changes in the defibrillation electrode surface area such as changing from a TRIAD configuration to a single coil configuration can affect the impedance measurements Baseline defibrillation impedance measurements should fall within the recommended values indicated in the table CAUTION R ...

Страница 26: ... lead placements 5 Once acceptable measurements are obtained remove the pacing system analyzer connections and remove the stylet 6 Pinch the terminal boot levers and slide the Connector Tool off of the proximal end of the lead 7 If additional repositioning and or PSA measurements are necessary reattach the Connector Tool ensuring the lead is fully inserted and repeat the evaluation process Connect...

Страница 27: ...y excess lead and place adjacent to the pulse generator It is important to place the lead into the pocket in a manner that minimizes lead tension twisting sharp angles and or pressure Electrical Performance 1 Evaluate the lead signals using the pulse generator 2 Place the pulse generator into the implant pocket as indicated in the pulse generator physician s manual Also refer to the instructions i...

Страница 28: ...on a one time conversion of a rhythm disturbance at a particular energy level does not necessarily predict future conversion energy levels Refer to the applicable pulse generator physician s manual for conversion testing guidelines Weigh the probability of reliable conversion in the ambulatory state against the availability of the pulse generator energy settings and the patient s ability to tolera...

Страница 29: ...lation or sever the vein Avoid dislodging the distal tip during the anchoring procedure CAUTION Do not suture directly over the lead body as this may cause structural damage Use the suture sleeve to secure the lead proximal to the venous entry site to prevent lead movement CAUTION Avoid removing or cutting the suture sleeve from the lead If removal of the suture sleeve is necessary use caution as ...

Страница 30: ...d lack of slippage by grasping the suture sleeve with fingers and trying to move the lead in either direction Venous Cutdown Technique 1 Slide the suture sleeve into the vein past the distal groove 2 Ligate the vein around the suture sleeve to obtain hemostasis 3 Using the same groove secure the lead and vein to the adjacent fascia Figure 11 Example of suture sleeve venous cutdown technique on pag...

Страница 31: ...is not present on the lead Do not directly contact the lead terminal with any surgical instruments or electrical connections such as PSA alligator clips ECG connections forceps hemostats and clamps This could damage the lead terminal possibly compromising the sealing integrity and result in loss of therapy or inappropriate therapy 2 Remove the stylet and Connector Tool NOTE A compatible tunneling ...

Страница 32: ...nals with the pulse generator as previously described If the measurements are unacceptable check the electrical connections A discontinuous or abnormal signal may indicate dislodgment a loose connection or lead damage If necessary reposition the lead electrodes until acceptable values are obtained To reposition the lead carefully withdraw the tunneled portion back to the venous entry site Release ...

Страница 33: ...servation or complications reasons NOTE Disposal of explanted pulse generators and or leads is subject to applicable laws and regulations For a Returned Product Kit contact Boston Scientific using the information on the back cover Consider the following items when explanting and returning the pulse generator and or lead Interrogate the pulse generator and print a comprehensive report Deactivate th...

Страница 34: ...a DF4 LLHH or DF4 LLHO terminal Fixation Tined Electrode Distal coil surface area 450 mm2 Proximal coil surface area dual coil models 660 mm2 Tip surface area 3 5 mm2 Tip to proximal coil electrode length dual coil models 18 cm Tip to distal coil electrode length 12 mm Diameter Insertion 2 7 mm 8F Isodiametric lead body 2 4 mm 7 3F Material External insulation Silicone rubber Terminal molding Poly...

Страница 35: ... terminal ring contact to distal coil electrode 2 5 Ω From high voltage distal terminal ring contact to proximal coil electrode dual coil models 2 5 Ω a MP35N is a trademark of SPS Technologies Inc Lead Introducer Table 6 Lead introducer Recommended lead introducer Introducer without guide wirea 8F 2 7 mm a When retaining a guide wire a 2 5F increase in introducer size is recommended Symbols on Pa...

Страница 36: ...cription Date of manufacture Sterilized using ethylene oxide Do not resterilize Do not reuse Do not use if package is damaged Consult instructions for use on this website www bostonscientific elabeling com Opening instruction Manufacturer MR Conditional ...

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Страница 40: ...ion 4100 Hamline Avenue North St Paul MN 55112 5798 USA www bostonscientific com 1 800 CARDIAC 227 3422 1 651 582 4000 2018 Boston Scientific Corporation or its affiliates All rights reserved 350062 007 EN US 2018 07 350062 007 ...

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