Boston Scientific EMBLEM S-ICD User Manual
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Boston Scientific EMBLEM S-ICD User Manual

Boston Scientific EMBLEM S-ICD User Manual

Subcutaneous electrode
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USER'S MANUAL
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EMBLEM
S-ICD
Subcutaneous Electrode
REF 3401

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Summary of Contents for Boston Scientific EMBLEM S-ICD

  • Page 1 USER’S MANUAL ™ EMBLEM S-ICD Subcutaneous Electrode REF 3401...
  • Page 3 The following are trademarks of Boston Scientific Corporation or its affiliates: EMBLEM and IMAGEREADY. This product may be protected by one or more patents. Patent information can be obtained at http://www.bostonscientific.com/patents.

  • Page 5: Table Of Contents

    USING THE S-ICD SYSTEM ..............7 Items Included in Package ..............7 IMPLANTING THE S-ICD SYSTEM............8 Creating the Device Pocket ..............9 Implanting the EMBLEM S-ICD Subcutaneous Electrode......9 POST-IMPLANT................13 Post Implant Follow-Up Procedures ........... 13 Explantation.................. 13 SPECIFICATIONS ................

  • Page 7: Introduction

    System detects cardiac activity and provides defibrillation 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 .

  • Page 8: Indications For Use

    Use, as defined in the MRI Technical Guide, are met. Components required for MR Conditional status include specific models of Boston Scientific S-ICD pulse generator, electrodes, and accessories; the Programmer; and Programmer Software Application. For the model numbers of MR Conditional S-ICD pulse generator and components, as well as a complete description of the ImageReady S-ICD System, refer to the MRI Technical Guide.

  • Page 9: Warnings

    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.

  • Page 10: Precautions

    • Do not implant in MRI site Zone III. Implant of the system cannot be performed in an MRI site Zone III (and higher) as defined by the American College of Radiology Guidance Document for Safe MR Practices . Some of the accessories packaged with pulse generators and electrodes, including the torque wrench and electrode insertion tool, are not MR Conditional and should not be brought into the MRI scanner room, the...
  • Page 11 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. •...

  • Page 12: Potential Adverse Events

    • 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.

  • Page 13: Using The S-Icd System

    • Inability to communicate with the device • Inability to defibrillate or pace • Inappropriate post-shock pacing • Inappropriate shock delivery • Infection • Keloid formation • Migration or dislodgement • Muscle/nerve stimulation • Nerve damage • Pneumothorax • Post-shock/post-pace discomfort •...

  • Page 14: Implanting The S-Icd System

    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.

  • Page 15: Creating The Device Pocket

    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.
  • Page 16 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. Make a small, 2 cm horizontal incision at the xiphoid process (xiphoid incision).
  • Page 17 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 subcutaneous electrode shaft using 2-0 silk or similar non-absorbable suture material, making sure not to cover the proximal sensing electrode.
  • Page 18 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. Using the secured suture at the superior incision, carefully pull the suture and subcutaneous electrode through the tunnel until the anchoring hole emerges.

  • Page 19: Post-Implant

    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. 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.
  • Page 20 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. CAUTION: Clean and disinfect implanted components using standard biohazard handling techniques.

  • Page 21: Specifications

    [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 EMBLEM S-ICD Subcutaneous Electrode Specifications Table 1. Electrode Specifications...

  • Page 22: Definitions Of Package Label Symbols

    Table 1. Electrode Specifications (continued) Suture Sleeve Material Silicone Storage Temperature Range -18°C to +55°C (0°F to +131°F) Maximum outer diameter 4.0 mm Defibrillation coil diameter 3.0 mm Lead shock impedance 25-200 Ω Maximum Lead Conductor Resistance From high voltage terminal ring 1 Ω...

  • Page 23: Warranty

    Australian Sponsor Address WARRANTY 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.
  • Page 28 PO Box 332 BOTANY NSW 1455 Australia Free Phone 1 800 676 133 Free Fax 1 800 836 666 www.bostonscientific.com 1.800.CARDIAC (227.3422) +1.651.582.4000 © 2015 Boston Scientific Corporation or its affiliates. All rights reserved. 359469-001 EN Europe 2015-09 Authorized 2015 *359469-001*...

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