Boston Scientific RELIANCE 4-FRONT Series Physician's Lead Manual
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Boston Scientific RELIANCE 4-FRONT Series Physician's Lead Manual

Boston Scientific RELIANCE 4-FRONT Series Physician's Lead Manual

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PHYSICIAN'S LEAD MANUAL
RELIANCE 4–FRONT
Pace/Sense and Defibrillation Lead
Integrated Bipolar DF4-LLHH and 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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Summary of Contents for Boston Scientific RELIANCE 4-FRONT Series

  • Page 1 PHYSICIAN’S LEAD MANUAL ™ RELIANCE 4–FRONT Pace/Sense and Defibrillation Lead Integrated Bipolar DF4-LLHH and 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...

  • Page 3: Table Of Contents

    Table of Contents INFORMATION FOR USE ..............1 Device Description ................1 Related Information ................2 MR Conditional System Information ............. 3 Indications and Usage............... 4 Contraindications ................4 Warnings..................4 Precautions ..................6 Potential Adverse Events..............10 Warranty Information ..............12 PRE- IMPLANT INFORMATION ............
  • Page 4 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 EZ-4, The following are trademarks of Boston Scientific Corporation or its affiliates: IMAGEREADY, IROX, RELIANCE 4–FRONT.

  • Page 5: Information For Use

    INFORMATION FOR USE Device Description The Boston Scientific Corporation RELIANCE 4-FRONT defibrillator lead is a 7.3 French (8F introducer), transvenous, steroid-eluting, integrated bipolar, DF- 4 compatible lead intended for permanent sensing, pacing, and defibrillation when used with a compatible Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillator (CRT-D).

  • Page 6: Related Information

    • IROX-coated tip electrode—the tip electrode is coated with IROX (iridium oxide) to increase the microscopic surface area. • Steroid-eluting—upon exposure to body fluids, the steroid elutes from the lead to help reduce tissue inflammation response at the distal electrode. The steroid suppresses the inflammatory response believed to cause threshold rises typically associated with implanted pacing electrodes.

  • Page 7: Mr Conditional System Information

    MR Conditional Defibrillation System • No evidence of a fractured lead or compromised pulse generator-lead system integrity Defined as a Boston Scientific MR Conditional pulse generator and lead(s), with all ports occupied by a lead or port plug.

  • Page 8: Indications And Usage

    • Intended for pacing, rate-sensing, and delivery of cardioversion and defibrillation shocks when used with a compatible pulse generator Contraindications Use of this Boston Scientific lead is contraindicated for the following patients: • Patients who have a unipolar pacemaker •...
  • Page 9 Handling • Excessive flexing. Although pliable, the lead is not designed to tolerate excessive flexing, bending, or tension. This could cause structural weakness, conductor discontinuity, and/or lead dislodgment. • Do not kink leads. Do not kink, twist, or braid the lead with other leads as doing so could cause lead insulation abrasion damage or conductor damage.

  • Page 10: Precautions

    If the packaging is wet, punctured, opened, or otherwise damaged, return the pulse generator and/or lead to Boston Scientific. • Storage temperature. Store at 25°C (77°F). Excursions are permitted between 15°C to 30°C (59°F to 86°F).
  • Page 11 • Chronic repositioning. Optimum threshold performance might not be achieved if the lead is chronically repositioned because the steroid can be depleted. • Protect from surface contamination. The lead uses silicone rubber which can attract particulate matter, and therefore, must always be protected from surface contamination.
  • Page 12 • Do not implant lead under clavicle. When attempting to implant the lead via a subclavian puncture, do not introduce the lead under the medial one- third region of the clavicle. Damage or chronic dislodgment to the lead is possible if the lead is implanted in this manner. If implantation via the subclavian vein is desired, the lead must enter the subclavian vein near the lateral border of the first rib to avoid entrapment by the subclavius muscle or ligamentous structures associated with the narrow...
  • Page 13 implant site to the chest area because this can damage the electrodes or lead body or both by permanently stretching the lead. • Excessive tension on lead. When tunneling the lead, take precautions not to place excessive tension on the lead. This can cause either structural weakness and/or conductor discontinuity.

  • Page 14: Potential Adverse Events

    • Keep the path of the electrical current as far away as possible from the pulse generator and leads. • If RF ablation 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.
  • Page 15 • Excessive fibrotic tissue growth • Extracardiac stimulation (muscle/nerve stimulation) • Fluid accumulation • Foreign body rejection phenomena • Formation of hematomas or seromas • Heart block • Hemorrhage • Hemothorax • Inability to defibrillate or pace • Inappropriate therapy (e.g., shocks and antitachycardia pacing [ATP] where applicable, pacing) •...

  • Page 16: Warranty Information

    ImageReady MR Conditional Defibrillation System MRI Technical Guide. Warranty Information A limited warranty certificate for the lead is available. For a copy, contact Boston Scientific using the information on the back cover. PRE- IMPLANT INFORMATION Proper surgical procedures and techniques are the responsibility of the medical professional.

  • Page 17: Accessories

    Literature Accessories Separately packaged lead accessories are available in addition to those packaged with the lead. Vein Pick The vein pick is a disposable plastic device designed to assist with insertion into a vein during a cutdown procedure. Radiopaque Suture Sleeve The radiopaque suture sleeve is an adjustable, tubular reinforcement that is visible under fluoroscopy.

  • Page 18: Lead Cap

    NOTE: Refer to the MRI Technical Guide for considerations affecting choice and implant of leads for use as part of an MR Conditional system.Use of Boston Scientific MR Conditional pulse generators and leads is required for an implanted system to be considered MR Conditional. Refer to the MRI Technical...

  • Page 19: Attaching The Connector Tool To The Lead

    NOTE: Other implanted devices or patient conditions may cause a patient to be ineligible for an MRI scan, independent of the status of the patient’s ImageReady MR Conditional System. Attaching the Connector Tool to the Lead Follow the steps below to attach the Connector Tool to the lead. Slide the Connector Tool onto the proximal end of the lead (Figure 2 Lead fully inserted into Connector Tool on page 15).

  • Page 20: Inserting The Lead

    Figure 3. Curve the stylet Carefully insert the stylet through the funnel of the Connector Tool and terminal pin. NOTE: To optimize insertion into the lead, do not allow body fluids to come in contact with the stylet. Ensure the stylet is fully inserted in the lead prior to inserting the lead into the vein.
  • Page 21 CAUTION: When attempting to implant the lead via a subclavian puncture, do not introduce the lead under the medial one-third region of the clavicle. Damage or chronic dislodgment to the lead is possible if the lead is implanted in this manner. If implantation via the subclavian vein is desired, the lead must enter the subclavian vein near the lateral border of the first rib to avoid entrapment by the subclavius muscle or ligamentous structures associated with the narrow costoclavicular region.
  • Page 22 [1] Subclavius muscle [2] Costocoracoid ligament [3] Costoclavicular ligament Figure 5. Entry point for percutaneous subclavian venipuncture Visually draw a line between St and Cp, and divide the segment into thirds. The needle should pierce the skin at the junction of the middle and lateral thirds, directly above the axillary vein (point Ax).

  • Page 23: Positioning Lead In Right Ventricle

    Feel with the thumb the pressure from the passage of the needle through the superficial fascia; direct the needle deep into the tissues toward the subclavian vein and the underlying first rib. Fluoroscopic guidance will reduce the chance that the needle would pass below the first rib and into the lung.

  • Page 24: Checking For Lead Stability

    Verify under fluoroscopy that the distal coil electrode is situated in the right ventricle, below the tricuspid valve, and that the proximal coil electrode (in dual-coil models) is situated in the superior vena cava and high right atrium. CAUTION: For patients with bipolar cardiac pacemakers, the lead pace/ sense electrode (the tip electrode and distal coil electrode) should be placed as far as possible from the pacemaker electrodes to avoid cross-sensing between the defibrillator pulse generator and the pacemaker.
  • Page 25 Figure 8. PSA clips attached to Connector Tool Perform the measurements as indicated in the table. Table 3. Recommended threshold and sensing measurements Signal Type Amplitude Duration Pacing Impedance Threshold Pacing/ ≥ 5 mV < 100 ms ≤ 1.5 V 300–1200 Ω...

  • Page 26: Connection To A Pulse Generator

    • Reinsert the stylet and reposition the lead using the procedures previously discussed and repeat the lead evaluation process. • If testing results are unsatisfactory, further lead system repositioning or replacement may be required. Consider the following information: • Low stimulation threshold readings indicate a desirable safety margin, since stimulation threshold may rise after implantation.

  • Page 27: Electrical Performance

    Apply gentle traction to the lead by grasping the labeled area of the lead body to ensure a secure connection. CAUTION: Insert the lead terminal straight into the lead port. Do not bend the lead near the lead-header interface. Improper insertion can cause insulation or connector damage.
  • Page 28 and shocking the patient with high-voltage pulses delivered from the pulse generator, through the defibrillation electrodes of the lead, to the heart. Baseline measurements should fall within the recommended values listed in the Recommended threshold and sensing measurements table (Table 3 Recommended threshold and sensing measurements on page 21).

  • Page 29: Securing The Lead

    Securing the Lead After the electrodes are satisfactorily positioned, use the suture sleeve to secure the lead to achieve permanent hemostasis and lead stabilization. Suture sleeve tie-down techniques can vary with the lead insertion technique used. Consider the following warning and precautions while securing the lead. WARNING: Do not kink, twist, or braid the lead with other leads as doing so could cause lead insulation abrasion damage or conductor damage.
  • Page 30 Using at least two grooves, ligate the suture sleeve and the lead to the fascia. For additional stability, the sleeve may be secured to the lead first before securing the sleeve to the fascia. Check the suture sleeve after tie-down to demonstrate stability and lack of slippage by grasping the suture sleeve with fingers and trying to move the lead in either direction.

  • Page 31: Tunneling The Lead

    Use at least two grooves to secure the sleeve to the lead. Secure the lead and suture sleeve to the adjacent fascia. Check the suture sleeve after tie-down to demonstrate stability and lack of slippage by grasping the suture sleeve with fingers and trying to move the lead in either direction.

  • Page 32: Postimplant

    Gently tunnel the lead subcutaneously from the vein insertion site to the implant pocket. CAUTION: Tunnel the lead from the chest area to the pulse generator implant site. Do not tunnel the lead from the pulse generator implant site to the chest area because this can damage the electrodes or lead body or both by permanently stretching the lead.

  • Page 33: Explantation

    Explantation NOTE: Return all explanted pulse generators and leads to Boston Scientific. Examination of explanted pulse generators and leads 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.
  • Page 34 Table 4. Model Number and Lead Length (continued) Model Single Coil/Dual Coil Length 0651 Dual Coil 70 cm 0662 Single Coil 59 cm 0663 Single Coil 64 cm 0650 Single Coil 70 cm Table 5. Specifications (Nominal) Characteristic Nominal Terminal type DF4-LLHH (dual-coil models) DF4-LLHO (single-coil models) Compatibility...

  • Page 35: Lead Introducer

    Table 5. Specifications (Nominal) (continued) Characteristic Nominal Tip electrode IROX (iridium oxide) coated Pt-Ir Distal fitting electrode Titanium Coil backfill Silicone Steroid 0.97 mg dexamethasone acetate Maximum Lead Conductor Resistance: From (low voltage) terminal pin to distal tip 80 Ω electrode From (low voltage) proximal terminal ring 80 Ω...
  • Page 36 Table 7. Symbols on packaging (continued) Symbol Description 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...
  • Page 40 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 © 2018 Boston Scientific Corporation or its affiliates. All rights reserved. 350062-007 EN US 2018-07 *350062-007*...

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