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EMBLEM™ S-ICD - Boston Scientific

1. Boston c enti USER S MANUAL EMBLEM S ICD Subcutaneous Electrode MODEL 3401 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 EMBLEM is a trademark of Boston Scientific This product may be protected by one or more patents Patent information can be obtained at http www bostonscientific com patents Table of Contents Description Related Information Intended Audience Indications for Use Contraindications Warnings General Handling Implantation Post Implant Precautions Clinical Considerations Sterilization and Storage Implantation Hospital and Medical Environments Explant and Disposal Potential Adverse Events Using the EMBLEM S ICD Subcutaneous Electrode Items Included in Package Implanting the EMBLEM S ICD System Creating the Device Pocket Implanting the EMBLEM S ICD Subcutaneous Electrode Post Implant Follow Up Procedures Explantation EMBLEM S ICD Subcutaneous Electrode Diagram EMBLEM S ICD Subcutaneous Electrode Specifications Definition of Package Label Symbols Warranty Information OMDOANNODOTPRPWWWWWWNNND aa ee ee ee es ee OU PwWN Description The EMBLEM S ICD subcutaneous electrode is a component of the Boston Scientific S ICD System which is prescribed for patients when cardiac arrhythmia management is warranted The S ICD System detects cardiac activity and provides defibrill
2. induction of atrial or ventricular arrhythmia e Adverse reaction to induction testing Allergic adverse reaction to system or medication e Bleeding e Conductor fracture e Cyst formation Death e Delayed therapy delivery e Discomfort or prolonged healing of incision e Electrode deformation and or breakage e Electrode insulation failure _ Erosion extrusion e Failure to deliver therapy Fever Hematoma seroma Hemothorax Improper electrode connection to the device e Inability to communicate with the device e Inability to defibrillate or pace e Inappropriate post shock pacing e Inappropriate shock delivery e Infection e Keloid formation e Migration or dislodgement Muscle nerve stimulation Nerve damage Pneumothorax Post shock post pace discomfort e Premature battery depletion Random component failures Stroke e Subcutaneous emphysema e Surgical revision or replacement of the system Syncope Tissue redness irritation numbness or necrosis If any adverse events occur invasive corrective action and or S ICD System modification or removal may be required 6 Patients who receive an S ICD System may develop psychological disorders that may include but are not limited to the following e Depression anxiety Fear of device malfunction e Fear of shocks Phantom shocks Using the EMBLEM S ICD Subcutaneous Electrode Items Incl
3. process xiphoid incision Note If desired in order to facilitate attachment of the suture sleeve to the fascia following electrode placement two suture ties to the fascia can be made at the xiphoid incision prior to continuing 2 Insert the distal tip of the EIT at the xiphoid incision and tunnel laterally until the distal tip emerges at the device pocket Note The EIT is malleable and can be curved to match the patient s anatomical profile Caution Use only the electrode insertion tool to create the subcutaneous tunnel when implanting and positioning the subcutaneous electrode Avoid tunneling close to any other subcutaneously implanted medical devices or components for example an implantable insulin pump drug pump or ventricular assist device 9 10 Using conventional suture material tie the anchoring hole of the subcutaneous electrode to the EIT creating a long 15 16 cm loop Figure 3 y Figure 3 Connecting the distal end of the subcutaneous electrode to the EIT With the subcutaneous electrode attached carefully pull the EIT back through the tunnel to the xiphoid incision until the proximal sensing electrode emerges Place a suture sleeve over the subcutaneous electrode shaft 1 cm below the proximal sensing electrode Using the preformed grooves bind the suture sleeve to the subcuta neous electrode shaft using 2 0 silk or similar non absorbable suture material making sure not to cover the proximal sensing electrode
4. the subcutaneous electrode at the superior incision to ensure the anchoring hole is secured to the fascia 14 To dispose of the EIT return the used product to the original package then dispose in a biohazard container 15 To ensure good tissue contact with the implanted subcutaneous electrode flush the xi phoid and superior incisions with sterile saline solution and apply firm pressure along the electrode to express any residual air out through the incisions prior to closing For information on connecting the subcutaneous electrode to the pulse generator as well as information about setup of the pulse generator and defibrillation testing refer to the appropriate S ICD pulse generator user s manual Either the Boston Scientific EMBLEM S ICD Pulse Generator User s Manual or the Cameron Health SQ RX Model 1010 Pulse Generator User s Manual depending on which S ICD pulse generator is being used Additional information on post implant follow up and explant of the system can also be found in the S ICD pulse generator manual Post Implant Follow Up Procedures It is recommended that device functions be evaluated with periodic follow up testing by trained personnel to enable review of device performance and associated patient health status throughout the life of the device Refer to the appropriate pulse generator literature for more information 12 During a follow up procedure it is recommended that the location of the subcutaneous el
5. Check the suture sleeve after anchoring to assure stability by grasping the suture sleeve with fingers and try to move the subcuta neous electrode in either direction Note Do not secure the suture sleeve and subcutaneous electrode to the fascia until electrode placement is complete Make a second incision approximately 14 cm superior to the xiphoid incision Superior incision If desired place the exposed subcutaneous electrode on the skin to make this measurement The distance between the superior and xiphoid incisions must accommo date the portion of the subcutaneous electrode from the distal sensing electrode to the proximal sensing electrode Pre place one or two fascial sutures in superior incision Use a non absorbable suture material of appropriate size for long term retention Apply gentle traction to ensure adequate tissue fixation Retain the needle on the suture for later use in passing through the electrode anchoring hole 7 Insert the distal tip of the EIT into the xiphoid incision and tunnel subcutaneously towards the superior incision staying as close to the deep fascia as possible Figure 4 Figure 4 Tunneling to superior incision 8 Once the distal tip of the EIT emerges from the superior incision disconnect and retain the suture loop from the distal tip of the EIT Secure the ends of the suture with a surgical clamp Remove the EIT 9 Using the secured suture at the superior incision carefully pull the suture and s
6. ate a 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 e Component Compatibility All Boston Scientific S ICD implantable components are designed for use with the Boston Scientific or Cameron Health S ICD System only Connection of any S ICD System components to a non compatible component will result in failure to deliver life saving defibrillation therapy e Backup defibrillation protection Always have external defibrillation equipment and medical personnel skilled in CPR available during implant and follow up testing If not terminated in a timely fashion an induced ventricular tachyarrhythmia can result in the patient s death Handling e Proper Handling Handle the components of the S ICD System with care at all times and maintain proper sterile technique Failure to do so may lead to injury illness or death of the patient e Do not damage components Do not modify cut kink crush stretch or otherwise damage any component of the S ICD System Impairment to the S ICD System may result in an inappropriate shock or failure to deliver therapy to the patient e Handling the subcutaneous electrode Use caution handling the subcutaneous electrode connector Do not directly contact the connector with any surgical instruments s
7. ation therapy The subcutaneous electrode is implanted with the distal portion positioned parallel to the left sternal border and the proximal end connected to an EMBLEM S ICD System pulse generator via an SQ 1 S ICD connector The EMBLEM subcutaneous electrode is also compatible with the Cameron Health Model 1010 SQ RX pulse generator The subcutaneous electrode includes one high voltage shock electrode coil for the purpose of providing defibrillation energy The shock electrode is constructed using multifilars of metallic wire formed into a defibrillation coil 8 cm in length Defibrillation is delivered between the coil on the subcutaneous electrode and the electrically conductive pulse generator case The subcutaneous electrode also includes proximal and distal sensing ring electrodes These sense electrodes are constructed using metallic tubing mechanically affixed to the body of the subcutaneous electrode Sensing occurs between the two electrically conductive rings on the subcutaneous electrode or between either of the rings on the subcutaneous electrode and the electrically conductive pulse generator case Related Information For additional information about other components of the S ICD System refer to the following EMBLEM S ICD Pulse Generator User s Manual e EMBLEM S ICD Subcutaneous Electrode Insertion Tool User s Manual EMBLEM S ICD Programmer User s Manual A summary of the S ICD System Clinical Investigation including observ
8. eceived it is sterile provided the container is intact If the packaging is wet punctured opened or otherwise damaged return the pulse generator and or subcutaneous electrode to Boston Scientific Use by date Implant the pulse generator and or subcutaneous electrode before or on the USE BY date on the package label because this date reflects a validated shelf life For example if the date is January 1 do not implant on or after January 2 Storage temperature The recommended storage temperature range is 18 C to 55 C O F to 131 F Implantation Creating the subcutaneous tunnel Use only the electrode insertion tool to create the subcutaneous tunnel when implanting and positioning the subcutaneous electrode Avoid tunneling close to any other subcutaneously implanted medical devices or components for example an implantable insulin pump drug pump or ventricular assist device Suture location Suture only those areas indicated in the implant instructions Do not suture directly over subcutaneous electrode body Do not suture directly over the subcutaneous electrode body as this may cause structural damage Use the suture sleeve to prevent subcutaneous electrode movement Do not bend the subcutaneous electrode near the electrode header interface Insert the subcutaneous electrode connector pin straight into the pulse generator header port Do not bend the subcutaneous electrode near the subcutaneous electrode header interface Impr
9. ectrode be periodically verified by palpation and or X ray When device communication with the programmer is established the programmer automatically notifies the physician of any unusual conditions Refer to the EMBLEM S ICD Programmer User s Manual for more information Warning Always have external defibrillation equipment and medical personnel skilled in CPR available during implant and follow up testing If not terminated in a timely fashion an induced ventricular tachyarrhythmia can result in the patient s death Patient management and follow up are at the discretion of the patient s physician but are recommended one month after implant and at least every 3 months to monitor the condition of the patient and evaluate device function Explantation Note Return all explanted pulse generators and subcutaneous electrodes to Boston Scientific Examination of explanted pulse generators and subcutaneous electrodes can provide information for continued improvement in system reliability and warranty considerations Warning Do not reuse reprocess or resterilize Reuse reprocessing or resterilization may compromise the structural integrity of the device and or lead to device failure which in turn may result in patient injury illness or death Reuse reprocessing or resterilization may also create a risk of contamination of the device and or cause patient infection or cross infection including but not limited to the transmission of i
10. ed adverse events can be obtained by contacting Boston Scientific using the information on the back cover Intended Audience This literature is intended for use by professionals trained or experienced in device implant and or follow up procedures 1 SQ 1 is a non standard connector unique to the S ICD System Indications for Use The S ICD System is intended to provide defibrillation therapy for the treatment of life threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia incessant ventricular tachycardia or spontaneous frequently recurring ventricular tachycardia that is reliably terminated with anti tachycardia pacing Contraindications Unipolar pacing and impedance based features are contraindicated for use with the S ICD System Warnings Note Before using the S ICD System read and follow all warnings and precautions provided in the EMBLEM S ICD Pulse Generator User s Manual General Labeling knowledge Read this manual thoroughly before using the S ICD System to avoid damage to the pulse generator and or subcutaneous electrode Such damage can result in patient injury or death e For single patient use only Do not reuse reprocess or resterilize Reuse reprocessing or resterilization may compromise the structural integrity of the device and or lead to device failure which in turn may result in patient injury illness or death Reuse reprocessing or resterilization may also cre
11. nd or fibrillation and may cause inappropriate shocks and inhibition of post shock pacing Additionally exercise caution when performing any other type of cardiac ablation procedure in patients with implanted devices If electrocautery or RF ablation is medically necessary observe the following to minimize risk to the patient and device e Program the pulse generator to Therapy Off mode Have external defibrillation equipment available Avoid direct contact between the electrocautery equipment or ablation catheters and the pulse generator and subcutaneous electrode Keep the path of the electrical current as far away as possible from the pulse generator and subcutaneous electrode If RF ablation and or electrocautery is performed on tissue near the device or subcutaneous electrode verify pulse generator function see the appropriate S ICD pulse generator manual for suggested post therapy follow up actions For electrocautery use a bipolar electrocautery system where possible and use short intermittent and irregular bursts at the lowest feasible energy levels When the procedure is finished return the pulse generator to Therapy On mode Explant and Disposal Handling at explant Clean and disinfect implanted components using standard biohazard handling techniques Potential Adverse Events Potential adverse events related to implantation of the S ICD System may include but are not limited to the following e Acceleration
12. nfectious disease s from one patient to another Contamination of the device may lead to injury illness or death of the patient Caution Clean and disinfect implanted components using standard biohazard handling techniques Contact Boston Scientific when any of the following occur When a product is removed from service e In the event of patient death regardless of cause along with an autopsy report if performed For other observation or complications Note Disposal of explanted pulse generators and or subcutaneous electrodes 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 subcutaneous electrode e interrogate the pulse generator and print all reports e Deactivate the pulse generator before explantation e Disconnect the subcutaneous electrode from the pulse generator 13 e If subcutaneous electrode is explanted attempt to remove it intact and return it regardless of condition Do not remove the subcutaneous electrode with hemostats or any other clamping tool that may damage it Resort to tools only if manual manipulation cannot free the subcutaneous electrode e Wash but do not submerge the pulse generator and subcutaneous electrode to remove body fluids and debris using a disinfectant solution Do not allow fluids to enter the pulse generat
13. oper insertion can cause insulation or connector damage Sternal wires When implanting the S ICD system in a patient with sternal wires ensure that there is no contact between the sternal wires and the distal and proximal sense electrodes for example by using fluoroscopy Compromised sensing can occur if metal to metal contact occurs between a sense electrode and a sternal wire If necessary re tunnel the electrode to ensure sufficient separation between the sense electrodes and the sternal wires Hospital and Medical Environments External defibrillation External defibrillation or cardioversion can damage the pulse generator or subcutaneous electrode To help prevent damage to implanted system components consider the following Avoid placing a pad or paddle directly over the pulse generator or subcutane ous electrode Position the pads or paddles as far from the implanted system components as possible Set energy output of external defibrillation equipment as low as clinically accept able e Following external cardioversion or defibrillation verify pulse generator function see the appropriate S ICD pulse generator manual for suggested post therapy follow up actions e Cardiopulmonary resuscitation Cardiopulmonary resuscitation CPR may temporarily interfere with sensing and may cause delay of therapy e Electrocautery and Radio Frequency RF Ablation Electrocautery and RF ablation may induce ventricular arrhythmias a
14. or s connector port Use a Boston Scientific Returned Product Kit to properly package the pulse generator and or subcutaneous electrode and send it to Boston Scientific EMBLEM S ICD Subcutaneous Electrode Diagram 45 cm T 1 Anchoring Hole 2 Distal Sensing Electrode 3 Defibrillation Coil 4 Proximal Sensing Electrode 5 Terminal electrode connection for proximal sensing electrode 6 SQ 1 S ICD connector non standard 7 Terminal electrode connection for defibrillation coil 8 Terminal Pin electrode connection for distal sensing electrode Figure 6 EMBLEM S ICD Model 3401 Subcutaneous Electrode Dimensions 14 EMBLEM S ICD Subcutaneous Electrode Specifications Table 1 Electrode Specifications Component Specification Connector SQ 1 S ICD connector non standard E e rt a oer Distal Tip Size Fro Coil Size 9 Fr Electrode S Shaft Size 7 Fr Distal Sensing Surface Area 36 mm Proximal Sensing Surface Area 46 mm Sensing Location Defibrillation Surface Area Defibrillation Location Insulation Material Electrode Material Sensing Conductors and Connector Pins Suture Sleeve Material a arme Range ena a aga ra Maximum o outer diameter Defibrillation coil diameter Lead si shock impedance JNR eich ee a a oe A acco ret sk eet il tl Mt ae tnt De PRN ls rte to defibrillation coil From low voltage terminal pin to distal sensing electrode ring From l
15. ow voltage distal terminal sensing electrode connection to proximal sensing electrode ring a post shock pacing uses the same vector as shocking Distal electrode at tip Proximal electrode 120 mm from tip 750 a SELL 20 mm from tip u Polyurethane o MP35N Silicone eee tone cae tee a eee o ee 18 to 55 C 0 F to 131 F 4 0 mm 3 0 mm Maximum Lead Conductor Resistance 15 Definition of Package Label Symbols Table 2 Packaging Symbols Description Description Sterilized using ethylene oxide Date of manufacture Authorized Representative in the European Community Serial number Temperature limitation Do not reuse Consult instructions for use Reference number Open here Do not resterilize Manufacturer SN SQ 1 S ICD connector non Lot number standard Do not use if package is dam aged Warranty Information A limited warranty certificate for the subcutaneous electrode is available at www bostonscientific com For a copy contact Boston Scientific using the information on the back cover 16 Boston Scientific 2015 Boston Scientific Corporation or its affiliates All rights reserved Boston Scientific 4100 Hamline Avenue North St Paul MN 55112 5798 USA www bostonscientific com 1 800 CARDIAC 227 3422 1 651 582 4000 359298 001 EN US 2015 02
16. subcutaneously in the left thoracic region Figure 1 The EIT is used to create the subcutaneous tunnels in which the electrode is inserted d _ i Tes Figure 1 Placement of the S ICD System Creating the Device Pocket The device is implanted in the left lateral thoracic region To create the device pocket make an incision such that the device can be placed in the vicinity of the left Sth and 6th intercostal spaces and near the mid axillary line Figure 2 This can be accomplished by making an incision along the inframammary crease Figure 2 Creating the device pocket Implanting the EMBLEM S ICD Subcutaneous Electrode The procedure described below is one of several surgical approaches that can be used to appropriately implant and position the electrode Regardless of the surgical approach the defibrillation coil must be positioned parallel to the sternum in close proximity to or in contact with the deep fascia approximately 2 cm from the sternal midline Figure 1 In addition good tissue contact with the electrode and pulse generator is important to optimize sensing and therapy delivery Use standard surgical techniques to obtain good tissue contact For example keep the tissue moist and flushed with sterile saline express any residual air out through the incisions prior to closing and when closing the skin take care not to introduce air into the subcutaneous tissue 1 Make a small 2 cm horizontal incision at the xiphoid
17. ubcuta neous electrode through the tunnel until the anchoring hole emerges The subcutane ous electrode should be parallel to the sternal midline with the defibrillation coil in close proximity to the deep fascia 10 Cut and discard the suture material 11 At the xiphoid incision secure the suture sleeve with the subcutaneous electrode to the fascia using 2 0 silk or similar non absorbable suture material Warning Use appropriate anchoring techniques as described in the implant procedure to prevent S ICD System dislodgement and or migration Dislodgement and or migration of the S ICD System may result in an inappropriate shock or failure to deliver therapy to the patient Caution Do not suture directly over the subcutaneous electrode body as this may cause structural damage Use the suture sleeve to prevent subcutaneous electrode movement Caution Suture only those areas indicated in the implant instructions Note Ensure that the suture is securely fastened to fascia by gently tugging on the suture prior to tying to the suture sleeve and subcutaneous electrode 11 12 At the superior incision secure the anchoring hole to the fascia using the pre placed sutures from step 6 Figure 5 Figure 5 Anchoring the distal electrode tip of the subcutaneous electrode Note Ensure that the suture is securely fastened to fascia by gently tugging on the suture prior to tying to the subcutaneous electrode anchoring hole 13 Gently tug
18. uch as forceps hemostats or clamps This could damage the connector A damaged connector may result in compromised sealing integrity possibly leading to compromised sensing loss of therapy or inappropriate therapy Implantation System dislodgement Use appropriate anchoring techniques as described in the implant procedure to prevent S ICD System dislodgement and or migration Dislodgement and or migration of the S ICD System may result in an inappropriate shock or failure to deliver therapy to the patient Post Implant e Magnetic Resonance Imaging MRI exposure Do not expose a patient to MRI scanning Strong magnetic fields may damage the pulse generator and or subcutaneous electrode possibly resulting in injury to or death of the patient e Diathermy Do not expose a patient with an implanted S ICD System to diathermy The interaction of diathermy therapy with an implanted S ICD pulse generator or electrode can damage the pulse generator and cause patient injury Precautions Clinical Considerations e Pediatric Use The S ICD System has not been evaluated for pediatric use Available Therapies The S ICD System does not provide long term bradycardia pacing cardiac resynchronization therapy CRT or anti tachycardia pacing ATP Sterilization and Storage e If package is damaged The blister trays and contents are sterilized with ethylene oxide gas before final packaging When the pulse generator and or subcutaneous electrode is r
19. uded in Package The subcutaneous electrode has been sterilized with ethylene oxide gas and is packaged ina sterile container that is suitable for use in the operating field Store in a clean dry area Each package contains the following One EMBLEM S ICD subcutaneous electrode Model 3401 Two silicone suture sleeves One EMBLEM S ICD Subcutaneous Electrode User s Manual Implanting the EMBLEM S ICD System This section presents the information necessary for implanting the EMBLEM S ICD subcutaneous electrode using the EMBLEM S ICD subcutaneous electrode insertion tool the EIT The EMBLEM S ICD subcutaneous electrode can also be implanted using the Cameron Health Model 4010 Q GUIDE EIT Warning All Boston Scientific S ICD implantable components are designed for use with the Boston Scientific or Cameron Health S ICD System only Connection of any S ICD System components to a non compatible component will result in failure to deliver life saving defibrillation therapy The S ICD System is designed to be positioned using anatomical landmarks However it is recommended to review a pre implant chest x ray in order to confirm that a patient does not have notably atypical anatomy e g dextrocardia Additionally it is not recommended to deviate from the implant instructions to accommodate for physical body size or habitus unless a pre implant chest x ray has been reviewed The device and subcutaneous electrode are typically implanted

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EMBLEM™ S-ICD - Boston Scientific