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 insertion tool
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Download this manual See also: User Manual
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.
USER'S MANUAL
™
EMBLEM
S-ICD
Subcutaneous Electrode Insertion Tool
Model 4711

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Summary of Contents for Boston Scientific EMBLEM S-ICD

  • Page 1 USER’S MANUAL ™ EMBLEM S-ICD Subcutaneous Electrode Insertion Tool Model 4711 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.
  • Page 3 The following are trademarks of Boston Scientific Corporation or its affiliates: EMBLEM.

  • Page 5: Table Of Contents

    Items Included in Package .....................7 Implanting the S-ICD System ....................7 Creating the Device Pocket....................8 Implanting the EMBLEM S-ICD Subcutaneous Electrode ..........9 EMBLEM S-ICD Subcutaneous Electrode Insertion Tool Diagram ..........18 EMBLEM S-ICD Subcutaneous Electrode Insertion Tool Specifications........................18 Definitions of Package Label Symbols...................19...

  • Page 7: Description

    DESCRIPTION The EMBLEM S-ICD subcutaneous electrode insertion tool (the "EIT") is a component of the Boston Scientific S-ICD System, which is prescribed for patients when cardiac arrhythmia management is warranted. The EIT is used to create a subcutaneous tunnel to facilitate implantation of the EMBLEM S-ICD subcutaneous electrode.

  • Page 8: Warnings

    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.

  • Page 9: Precautions

    When the electrode insertion tool is received, it is sterile provided the container is intact. If the packaging is wet, punctured, opened, or otherwise damaged, return the electrode insertion tool to Boston Scientific. • Use by date. Use the electrode insertion tool before or on the USE BY date on the package label because this date reflects a validated shelf life.

  • Page 10: Potential Adverse Events

    Implantation • Creating the subcutaneous tunnel. Use 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 11 • Allergic/adverse reaction to system or medication • Bleeding • Conductor fracture • Cyst formation • Death • Delayed therapy delivery • Discomfort or prolonged healing of incision • Electrode deformation and/or breakage • Electrode insulation failure • Erosion/extrusion • Failure to deliver therapy •...
  • Page 12 • Keloid formation • Migration or dislodgement • Muscle/nerve stimulation • Nerve damage • Pneumothorax • Post-shock/post-pace discomfort • Premature battery depletion • Random component failures • Stroke • Subcutaneous emphysema • Surgical revision or replacement of the system • Syncope •...

  • Page 13: Using The S-Icd System

    (the “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 14: Creating The Device Pocket

    Figure 1. Placement of the S-ICD System (Model 3501 Electrode shown) 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 5th and 6th intercostal spaces and near the mid-axillary...

  • Page 15: Implanting The Emblem S-Icd Subcutaneous Electrode

    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. Alternate surgical approaches could be considered if system placement requirements can be achieved.
  • Page 16 Make a small, 2 cm horizontal incision at the xiphoid process (xiphoid incision). The size and orientation may vary at the physician’s discretion based on the patient’s body habitus. 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.
  • Page 17 Using conventional suture material, tie the anchoring hole of the subcutaneous electrode to the EIT, creating a long 15-16 cm loop (Figure 3 Connecting the Distal End of the Subcutaneous Electrode to the EIT on page 11). Figure 3. Connecting the Distal End of the Subcutaneous Electrode to the EIT...
  • Page 18 With the subcutaneous electrode attached, carefully pull the EIT back through the tunnel to the xiphoid incision until the proximal sensing electrode emerges. If using S-ICD Subcutaneous Electrode Model 3401, 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 19 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 accommodate the portion of the subcutaneous electrode from the distal sensing electrode to the proximal sensing electrode.
  • Page 20 Figure 4. Tunneling to Superior Incision...
  • Page 21 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 22 At the superior incision, secure the anchoring hole to the fascia using the pre-placed sutures from step 6 (Figure 5 Anchoring the Distal Tip of the Subcutaneous Electrode on page 16). Figure 5. Anchoring the Distal 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.
  • Page 23 Gently tug the subcutaneous electrode at the superior incision to ensure the anchoring hole is secured to the fascia. To dispose of the EIT, return the used product to the original package, then dispose in a biohazard container. To avoid air entrapment and ensure good tissue contact with the implanted subcutaneous electrode, flush all incisions with sterile saline solution and apply firm pressure along the electrode to expel any residual air out through the incisions prior to closing.

  • Page 24: Emblem S-Icd Subcutaneous Electrode Insertion Tool Diagram

    EMBLEM S-ICD SUBCUTANEOUS ELECTRODE INSERTION TOOL DIAGRAM [1] Distal Tip, [2] Handle Figure 6. Model 4711 dimensions EMBLEM S-ICD SUBCUTANEOUS ELECTRODE INSERTION TOOL SPECIFICATIONS Table 1. Specifications Component Specification Electrode insertion tool materials Acrylonitrile-butadiene-styrene (ABS), stainless steel Transportation, Handling, and Storage Temperature -18°C to +55°C (0°F to +131°F)

  • Page 25: Definitions Of Package Label Symbols

    DEFINITIONS OF PACKAGE LABEL SYMBOLS The following symbols may be used on packaging and labeling. Table 2. Packaging Symbols Symbol Description Sterilized by gamma irradiation Date of manufacture Authorized Representative in the European Community Use by Lot number Reference number...
  • Page 26 Table 2. Packaging Symbols (continued) Symbol Description Temperature limitation Open here Consult instructions for use on this website: www. bostonscientific-elabeling.com Do not resterilize Do not reuse...

  • Page 27: Warranty Disclaimer

    Boston Scientific’s obligations under any warranty provided herein shall be limited strictly to replacement of the product. Buyer assumes all risk of loss or damages arising from use of this product.
  • Page 32 Boston Scientific Corporation 4100 Hamline Avenue North St. Paul, MN 55112–5798 USA www.bostonscientific.com 1.800.CARDIAC (227.3422) +1.651.582.4000 © 2016 Boston Scientific Corporation or its affiliates. All rights reserved. 359471-002 EN US 2016-11 *359471-002*...

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