PHYSICIAN’S LEAD MANUAL

Implantable Lead

FINELINE™ II STEROX

4456/4457/4458/4459/4479/4480

TABLE OF CONTENTS

DESCRIPTION............................................................. 1MR Conditional Pacing System Information............ 1Implant-related MRI Conditions of Use ................... 1

RELATED INFORMATION .......................................... 2Intended Audience .................................................. 2Lead Features ......................................................... 2

INDICATIONS.............................................................. 2CONTRAINDICATIONS............................................... 2WARNINGS ................................................................. 3PRECAUTIONS ........................................................... 4

General ................................................................... 4Handling .................................................................. 4Implanting................................................................ 5

POTENTIAL ADVERSE EVENTS ............................... 5WARRANTY ................................................................ 6IMPLANT INFORMATION ........................................... 6

Precautions ............................................................. 7Sterilization.............................................................. 7Storage.................................................................... 7Handling .................................................................. 7General Information ................................................ 7

res ............................................... 8ements ....................................... 9..................................................10................................................... 11ANTED PRODUCTS...................12KAGING.....................................13....................................................13

, and IROX are trademarks of Boston Scientific rporation or its affiliates.

Insertion ProceduThreshold MeasurSecuring the Lead

POSTIMPLANT.......RETURNING EXPLSYMBOLS ON PACSPECIFICATIONS..

FINELINE, ImageReadyCo

1

DESCRIPTIONThe FINELINE™ II Sterox models 4456, 4457, 4458, 4459, 4479, and 4480 bipolar endocardial pacing leads are designed for use with implantable pulse generators for long-term cardiac pacing.

MR Conditional Pacing System InformationThese leads can be used as part of the ImageReady™ MR Conditional Pacing System when connected to Boston Scientific ImageReady MR Conditional pulse generators. Patients with an MR Conditional Pacing System may be eligible to undergo MRI scans if performed when all Conditions of Use, as defined in the ImageReady MR Conditional Pacing System MRI Technical Guide1 (MRI Technical Guide), are met. Components required for MR Conditional status include specific models of Boston Scientific pulse generators, leads, and accessories; the Programmer/Recorder/Monitor (PRM); and PRM Software Application. For the model numbers of MR Conditional pulse generators and components, as well as a complete description of the ImageReady MR Conditional Pacing System, refer to the MRI Technical Guide.

Implant-related MRI Conditions of UseThe 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 list of Con-

applicable MRI Technical Guide. All items s of Use must be met in order for an MRI Conditional.

th the ImageReady MR Conditional Pacing

n or pacing offt location restricted to left or right pectoral

ave elapsed since implantation and/or any l modification of the MR Conditional

ic-elabeling.com.R Conditional pulse generator and lead(s), with all ports

ditions of Use, refer to theon the full list of Conditionscan to be considered MR• Patient is implanted wi

System2

• Bipolar pacing operatio• Pulse generator implan

region• At least six (6) weeks h

lead revision or surgicaPacing System

1. Available at www.bostonscientif2. Defined as a Boston Scientific M

occupied by a lead or port plug.

• No cardiac-related implanted devices, components, or accessories present other than the ImageReady MR Conditional Pacing System

• Pacing threshold ≤ 2.0 V in pace-dependent patients• No abandoned leads or pulse generators• No evidence of a fractured lead or compromised pulse generator-

lead system integrity

RELATED INFORMATIONFor additional information, go to www.bostonscientific-elabel-ing.com.

Intended AudienceThis literature is intended for use by professionals trained or experi-enced in device implant and/or follow-up procedures.

Lead FeaturesA silicone rubber collar at the distal tip contains 0.75 mg of dexa-methasone acetate. Each lead is composed of two individually coated conductor wires coradially wound together to form a single conductor coil. The lead includes silicone rubber or polyurethane outer insulation, iridium oxide-coated (IROX™) titanium tip electrode and a platinum iridium anode. The distal slotted/blunt tip electrode is coated with polyethylene glycol. Fixation is achieved by silicone rub-ber tines. The lead is compatible with pulse generators having IS-13 connectors.

dance values, determined according to 5502-2-1:2003 (paragraphs 6.2.2 and 5 Ω and 595-790 Ω, respectively. Note that from in vitro testing, and are not represen-d lead impedance.

r single-use only.

hronic pacing and sensing of the ventricle or the atrium (4479, 4480) when used with ator.

tients with:

eart valves

andard ISO 5841-3:2013.

2

Pacing and sensing impeEuropean Standard EN 46.2.3), are within 780-112these values are derived tative of clinically measure

This device is intended fo

INDICATIONSThe lead is intended for c(4456, 4457, 4458, 4459) a compatible pulse gener

CONTRAINDICATIONSDo not use this lead in pa

• mechanical tricuspid h

3. IS-1 refers to the international st

3

• hypersensitivity to a maximum single dose of 0.94 mg dexamethasone acetate

WARNINGS

NOTE: Refer to the MRI Technical Guide for a complete list of MRI-related Warnings and Precautions.

• Unless all of the MRI Conditions of Use (as described in the MRI Technical Guide) are met, MRI scanning of the patient does not meet MR Conditional requirements for the implanted system, and significant harm to or death of the patient and/or damage to the implanted system may result. Refer to the MRI Technical Guide for potential adverse events applicable when Conditions of Use are met or not met, as well as for a complete list of MRI-related Warnings and Precautions.

• 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 Practices4. Some of the accessories packaged with pulse generators and leads, including the torque wrench and stylet wires, are not MR Conditional and should not be brought into the MRI scanner room, the control room, or the MRI site Zone III or IV areas.

• The use of battery-powered equipment is recommended during esting to protect against fibrillation that rnating currents.nt used in the vicinity of the patient must

ust be insulated from any leakage from line-powered equipment.atients with implanted leads should not

tment. Shortwave or microwave diathermy ge and injure the patient.

only. Do not reuse, reprocess, or ocessing, or resterilization may ural integrity of the device and/or lead to turn, may result in patient injury, illness, or ssing, or resterilization may also create a f the device and/or cause patient infection

l of Roentgenology 188:1447-74, 2007.

lead implantation and tmay be caused by alte

• Line-powered equipmebe properly grounded.

• Lead connector pins mcurrents that may arise

• Diathermy exposure. Preceive diathermy treacan cause tissue dama

• For single patient use resterilize. Reuse, reprcompromise the structdevice failure which, indeath. Reuse, reprocerisk of contamination o

4. Kanal E, et al., American Journa

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.

PRECAUTIONSGeneral

NOTE: 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 Guide for model numbers of pulse generators, leads, accessories, and other system components needed to satisfy the Conditions of Use for MR Conditional scanning.

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 Pacing System.

• Inspect sterile packaging prior to opening. Do not use if damaged. (See “Sterilization” on page 7.)

• Prior to the implantation of this lead, confirm lead/pulse generator compatibility by contacting Boston Scientific using the information on the back cover.

• Defibrillating equipment should be kept nearby for immediate use procedure.

ined whether the warnings, precautions, or ssociated with injectable dexamethasone e of this lead. Refer to the current rence™ 5 for potential adverse effects.

sive force or surgical instruments, as n could cause leakage and/or prevent

e the electrode in fluid.when securing the lead to avoid placing tension.

ductor coil, since attempts to restore the aken the structure.

trademark of Thomson Healthcare Inc.

4

during the implantation• It has not been determ

complications usually aacetate apply to the usPhysicians’ Desk Refe

Handling• Avoid the use of exces

damage to the insulatioproper lead function.

• Do not wipe or immers• Use the suture sleeve

the lead under extreme• Avoid bending the con

original shape may we

5. Physicians’ Desk Reference is a

5

Implanting• The subclavian venipuncture technique for lead introduction may

be associated with an increased risk of conductor failure due to compressive forces generated in the medial angle between the clavicle and the first rib; thus, an extremely medial introduction site should be avoided.

• Remove the stylet and stylet guide/cap before connecting the lead to the pulse generator. Leaving the stylet in the lead could cause coil fracture and/or heart perforation.

• Do not suture directly to the insulation. Always use the suture sleeve to anchor the lead.

POTENTIAL ADVERSE EVENTSBased on the literature and on pulse generator and/or lead implant experience, the following list includes the possible adverse events associated with implantation of products described in this literature:

• Air embolism• Allergic reaction• Arterial damage with subsequent stenosis• Bleeding• Bradycardia• Breakage/failure of the implant instruments• Cardiac perforation• Cardiac tamponade

dehydration

e growthn (muscle/nerve stimulation)

phenomenaas or seromas

py

• Chronic nerve damage• Component failure• Conductor coil fracture• Death• Electrolyte imbalance/• Elevated thresholds • Erosion• Excessive fibrotic tissu• Extracardiac stimulatio• Fluid accumulation• Foreign body rejection• Formation of hematom• Heart block• Hemmorhage• Hemothorax• Inability to deliver thera

• Inability to pace• Inappropriate therapy (e.g., shocks and antitachycardia pacing

[ATP] where applicable, pacing)• Incisional pain• Incomplete lead connection with pulse generator• Infection including endocarditis• Lead dislodgement• Lead fracture• Lead insulation breakage or abrasion• Lead tip deformation and/or breakage• Malignancy or skin burn due to fluoroscopic radiation• Myocardial trauma (e.g., tissue damage, valve damage)• Myopotential sensing• Oversensing/undersensing • Pericardial rub, effusion• Pneumothorax• Pulse generator and/or lead migration• Syncope• Tachyarrhythmias, which include acceleration or arrhythmias and

early, recurrent atrial fibrillation• Thrombosis/thromboemboli• Valve damage• Vasovagal response

erforation, dissection, erosion)

l Adverse Events associated with MRI I Technical Guide.

ate for the lead is available. For a copy, using the information on the back cover.

MRI Technical Guide for considerations plant of leads for use as part of an MR

s and techniques are the responsibility of The described implant procedures are fur-urposes only. Each physician must apply

6

• Venous occlusion• Venous trauma (e.g., p

For a list of Potentiascanning, refer to the MR

WARRANTYA limited warranty certificcontact Boston Scientific

IMPLANT INFORMATION

NOTE: Refer to theaffecting choice and imConditional system.

Proper surgical procedurethe medical professional. nished for informational p

7

the information in these instructions according to professional medi-cal training and experience.

Precautions• Remove the stylet and stylet guide/cap before connecting the

lead to the pulse generator. Leaving the stylet in the lead could cause coil fracture and/or heart perforation.

• Do not suture directly to the insulation. Always use the suture sleeve to anchor the lead.

SterilizationThis product is supplied in a sterile package for direct introduction into the operating field. The package and its contents have been exposed to ethylene oxide gas, and sterility is verified on each lot. Before the package is opened, it should be examined carefully for damage that may have compromised sterility. (For instructions on opening the sterile package, see Figure 1 and 2.) If such damage is detected, the entire contents should be returned to Boston Scien-tific.

StorageStore at 25°C (77°F). Excursions permitted between 15°C to 30°C (59°F to 86°F). Transportation spikes permitted up to 50°C (122°F).

HandlingThe conductor or its insulating material may be damaged if stretched, crimped, or crushed. Avoid subjecting the lead to these or

rial has an electrostatic affinity for particu-ld not be exposed to lint, dust, or other

sive force or surgical instruments, as on could cause leakage and/or prevent

e the electrode in fluid.when securing the lead to avoid placing tension.

ductor coil, since attempts to restore the aken the structure.

the lead so as to minimize mechanical ectrical contact with the cardiac wall.

other unusual stresses.

The lead’s insulating matelate matter and thus shousimilar contaminants.

Precautions• Avoid the use of exces

damage to the insulatiproper lead function.

• Do not wipe or immers• Use the suture sleeve

the lead under extreme• Avoid bending the con

original shape may we

General InformationIt is important to position stresses and maximize el

Implantation should, therefore, be performed in a facility permitting fluoroscopic verification of satisfactory lead tip placement.

Available transvenous implantation routes include the cephalic, sub-clavian and external or internal jugular veins. Venous access can be gained by employing either the venipuncture (suitable for the sub-clavian or internal jugular routes) or cutdown (suitable for the cephalic or external jugular routes) techniques.

If the subclavian route is selected and access by venipuncture is preferred, a percutaneous lead introducer (7 French or larger) should be used, and its application should be guided by the follow-ing considerations:

Precautions• The subclavian venipuncture technique for lead introduction may

be associated with an increased risk of conductor failure due to compressive forces generated in the medial angle between the clavicle and the first rib; thus, an extremely medial introduction site should be avoided.

Insertion ProceduresTo employ the cutdown technique, expose and incise the desired vein. For the venipuncture technique, insert a lead-introducer sheath into the desired vein (see instruction sheet packaged with introducer). Under fluoroscopic observation and with a straight stylet fully inserted into the lead, either introduce the lead into the incised

ance the lead through the lead-introducer d vein (for venipuncture - see Figure 3). If ded in the sterile package may be used to

(see Figure 4) when employing the cut-

ad. If resistance is encountered, withdraw and then readvance it. Repeat this proce-rs the right atrium. The tip of an atrial or vanced to the desired stimulation site by rocedures below:

d tip into the right atrium, partially that the lead’s distal end begins resuming anteromedially.

8

vein (for cutdown), or advsheath and into the desiredesired, the vein pick inclufacilitate lead introductiondown technique.

Cautiously advance the lethe lead a short distance dure until the lead tip enteventricular lead can be adfollowing one of the two p

Atrial Placement1. After advancing the lea

withdraw the stylet so its J shape and points

9

2. Maintaining fluoroscopic observation, advance the lead tip while holding the stylet stationary until the tip enters and becomes lodged in the atrial appendage.

3. If the lead tip is properly lodged in the appendage, the lead’s J curve will straighten slightly when the lead is gently retracted a short distance. Under AP fluoroscopy, the lead tip should point medially toward the left atrium and should sway from side to side with each atrial contraction.

Ventricular Placement1. After advancing the lead tip into the right atrium, replace the

straight stylet with one that has been slightly curved at the distal end. (Curve the stylet as shown in Figure 5.) The curve will assist in passing the lead across the tricuspid valve into the ventricle.

2. Once the lead has entered the ventricle, the straight stylet should be used again to cautiously advance the lead until the tip is lodged in the trabeculae at the apex. Exercise care to avoid perforating the ventricular wall.

3. Verify with lateral fluoroscopy that the lead tip is not in a posterior position, which would probably indicate that it has entered the coronary sinus and must be repositioned.

Threshold MeasurementsA pacemaker system analyzer is recommended for measuring the stimulation threshold and the appropriate sensing signal amplitude.

stylet should be withdrawn. g threshold should be sought.

ute stimulation threshold below 0.6 V or tained. However, maintaining the same xceed 1.0 V or 2.0 mA. For satisfactory nsing signal amplitude should be at least d impedance range is 200-2000 Ω .

lds are usually lower than 1.0 V or 2.0 mA atrial thresholds above 1.5 V or 3.0 mA est a need to reposition the lead. The itude will typically range from 0.5 to 4.0 or above is preferable. The recom- is 200-2000 Ω .

During this procedure, theThe lowest possible pacin

VentricularUsing a 500 Ω load, an ac1.2 mA can usually be obresistance, it should not esensing, the ventricular se5.0 mV. The recommende

AtrialAcute stimulation threshowith a 500 Ω load. Acute (using a 500 Ω load) suggatrial sensing signal amplmV, but a value of 1.5 mVmended impedance range

CAUTION: Be sure that the stylet has been removed before connecting the lead to the implanted pulse generator. Leaving the stylet in the lead could cause coil fracture and/or heart perforation. Also be sure that any stylet guide/cap installed over the lead connector(s) (as a guide for the stylet and to maintain lubrication of the connector) has been removed.

Securing the LeadOnce electrode stability and a satisfactory stimulation threshold have been attained, slide the pre-installed suture sleeve into posi-tion at the desired anchor point. Secure the sleeve to the lead by tying a non-absorbable suture around the sleeve near its middle (see Figure 6). Pass an end of the same suture through subcutane-ous tissue and, once again, tie it around the sleeve.

Notes: • The suture should be tied tight enough to prevent the lead from

moving within the sleeve, but not so tight that it might deform the lead’s conductor coil.

• Do not tie the suture directly to the lead body.

outer tray. Using the folded corner flap, remove the

y to present the lead and accessories (Figure 2).

10

1. Peel back the cover from the sterile inner tray (Figure 1).

2. Peel the lid from the inner tra

11

3. Advance the lead through the sheath of a percutaneous introducer and into the vein (Figure 3).

4. The vein pick may be used to lift and dilate the incised vein for introducing the lead (Figure 4).

tylet by drawing it through a gloved hand or across a re 5).

e into the desired anchor position, and secure with a ).

ion as recommended in the applicable ’s manual.

Lead

Vein Pick

Vein

Suture Sleeve

Vein

re Groove

5. Impart a gentle curve to the ssmooth, sterile instrument (Figu

6. Slide the integral suture sleevnonabsorbable suture (Figure 6

POSTIMPLANTPerform follow-up evaluatpulse generator physician

Sutu

Lead

RETURNING EXPLANTED PRODUCTSNOTE: Return all explanted pulse generators and leads to Boston

Scientific. Examination of explanted leads can provide information for continued improvement in system reliability and warranty considerations.

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.

12

13

SYMBOLS ON PACKAGING

Symbol Definition

Opening instruction

Do not reuse

Consult instructions for use on this website: www.bostonscientific-elabeling.com

Do not resterilize

Sterilized using ethylene oxide

Reference number

Use by

Date of manufacture

Lot number

ial number

not use if package is damaged

Conditional

4479/4480 (Atrial)56/4457 (Ventricular)

4458/4459(Ventricular)

Bipolar Bipolar

.bost

onsc ient i f i c-elabeling.comwww

SPECIFICATIONS

Ser

Do

MR

44

Polarity

Distal Assembly

Introducer size/insertion diameter (minimum)

7 Fr/2.3 mm 7 Fr/2.3 mm

Tine material Silicone rubber Silicone rubber

Eluting Collar Silicone rubber Silicone rubber

Steroid Dexamethasone acetate (0.75 mg)

Dexamethasone acetate (0.75 mg)

Electrode(s)

Tip (cathode)

Shape Slotted/blunt Slotted/blunt

Diameter 1.9 mm (5.7 French) 1.9 mm (5.7 French)

Surface area 5 mm2 5 mm2

Materials IROX (Iridium oxide coated titanium)

IROX (Iridium oxide coated titanium)

Coating (soluble)a Polyethylene glycol Polyethylene glycol

Sleeve (anode)

Surface area 31 mm2 33 mm2

Materials Platinum iridium Platinum iridium

Separation between electrodes

16 mm 16 mm

Lead Body

Conductor construction Parallel-wound bifilar coil Parallel-wound bifilar coil

Conductor material Nickel-cobalt alloy with silver core

Nickel-cobalt alloy with silver core

mer material Polymer material

polyurethane 80A Silicone rubber

: 52 cm: 58 cm: 45 cm: 52 cm

4458: 52 cm4459: 58 cm

m (5 Fr) 2 mm (6 Fr)

maximum 40 Ω maximum

maximum 40 Ω maximum

m (IS-1b) 3.2 mm (IS-1b)

one rubber, 316L tainless steel

Silicone rubber, 316L stainless steel

10 N

m 1.6 mm

m 2.7 mm

4479/4480 (Atrial)4456/4457 (Ventricular)

4458/4459(Ventricular)

14

Conductor wire insulation Poly

Insulation 55D

Length 4456445744794480

Diameter 1.7 m

Resistance

To tip 40 ΩTo sleeve 40 ΩConnector Assembly

Diameter 3.2 m

Materials Silics

Retention Strengthc 10 N

Connector pin diameters

Cathode 1.6 m

Anode 2.7 m

15

Connector pin length 5 mm 5 mm

Accessories included StyletsStylet guideVein pick

StyletsStylet guideVein pick

a. The tip electrode is encapsulated in polyethylene glycol (PEG), which is intended to maintain the cleanliness of the electrode during the packaging process.

b. IS-1 refers to the international standard ISO 5841-3:2013.

c. Maximum proven connector retention strength in Intermedics’ Side-Lock connector. Tested according to prEN45502-2, September 16, 1996.

4479/4480 (Atrial)4456/4457 (Ventricular)

4458/4459(Ventricular)

Cardiac Pacemakers Incorporated a wholly owned subsidiary of Guidant Corporation a wholly owned subsidiary of Boston Scientific Corporation4100 Hamline Avenue NorthSt. Paul, MN 55112-5798 USA

1.800.CARDIAC (227.3422)+1.651.582.4000

www.bostonscientific.com

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