Medtronic 407385 Technical Manual

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CAPSURE SENSE® 4073
Steroid-eluting, unipolar, implantable, tined, ventricular, transvenous lead
Technical Manual
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
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The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries. All other trademarks are the property of their respective owners.
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Contents

1 Description 3 2 Drug component description 3 3 Indications 3 4 Contraindications 3 5 Warnings and precautions 4 6 Drug information 5 7 Potential adverse events 5 8 Directions for use 6
9 Specifications 10 10 Medtronic warranty 11 11 Service 11

1.2 Accessory descriptions

Dispose of all single-use accessories according to local environmental requirements.
Anchoring sleeve – An anchoring sleeve secures the lead to prevent it from moving and protects the lead insulation and conductors from damage caused by tight sutures.
Stylet – A stylet provides additional stiffness and controlled flexibility for maneuvering the lead into position. Each stylet knob is labeled with the stylet diameter and length.
Stylet guide – A stylet guide facilitates stylet insertion into the lead.
Vein lifter – A vein lifter facilitates lead insertion into a vein.

2 Drug component description

1 Description

The Medtronic CapSure Sense Model 4073 steroid-eluting, unipolar, implantable, tined, ventricular, transvenous lead is designed for ventricular pacing. The platinum alloy tip electrode features a high-active surface area of titanium nitride microstructure. This electrode configuration contributes to low polarization.
The tip electrode of the lead incorporates a steroid-eluting plug containing dexamethasone acetate. The tip electrode contains a target nominal dosage of 272 µg of dexamethasone. Upon exposure to body fluids, the steroid elutes from the electrode.
The lead is designed to provide low chronic pacing thresholds via steroid treatment of cardiac tissue near the lead tip. Steroid suppresses the inflammatory response that is believed to cause threshold rises typically associated with implanted pacing electrodes.
The lead features four polyurethane tines near the electrode tip, an MP35N nickel-alloy conductor, polyurethane insulation and an IS-1 Unipolar (UNI)1 lead connector.

1.1 Package contents

The lead and accessories are supplied sterile. Each package contains the following items:
1 lead with anchoring sleeve, stylet, and stylet guide
1 vein lifter
extra stylets
product documentation
The active ingredient in the Model 4073 lead is dexamethasone acetate. Dexamethasone acetate is 9-Fluoro-11β, 17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 21-acetate. Dexamethasone acetate has a molecular formula of C24H31FO6 and a molecular weight of 434.50. The MCRD excipient is silicone. See Figure 1 for the structural formula.
Figure 1.
The target dosage of dexamethasone acetate is 272 µg per lead.

3 Indications

The Model 4073 implantable, ventricular, transvenous lead has application where implantable ventricular, single-chamber or dual-chamber pacing systems are indicated. The lead is intended for pacing in the ventricle.

4 Contraindications

Use of ventricular transvenous leads is contraindicated in patients with tricuspid valvular disease.
Use of ventricular transvenous leads is contraindicated in patients with mechanical tricuspid heart valves.
Use of steroid eluting transvenous leads is contraindicated in patients for whom a single dose of 272 µg dexamethasone acetate may be contraindicated.
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IS-1 UNI refers to an International Connector Standard (ISO 5841-3) whereby pulse generators and leads so designated are assured of a basic mechanical fit.
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5 Warnings and precautions

Note: Medical procedure warnings and precautions that pertain
to the Medtronic implanted system are provided in the manual that is packaged with the device or on the Medtronic Manual Library website (www.Medtronic.com/manuals).
Line-powered and battery-powered equipment – An implanted lead forms a direct current path to the myocardium. During lead implant and testing, use only battery-powered equipment or line-powered equipment specifically designed for this purpose to protect against fibrillation that may be caused by alternating currents. Line-powered equipment used in the vicinity of the patient must be properly grounded. Lead connector pins must be insulated from any leakage currents that may arise from line-powered equipment.
Diathermy treatment (including therapeutic ultrasound) –
Diathermy is a treatment that involves the therapeutic heating of body tissues. Diathermy treatments include high frequency, short wave, microwave, and therapeutic ultrasound. Except for therapeutic ultrasound, do not use diathermy treatments on cardiac device patients. Diathermy treatments may result in serious injury or damage to an implanted device and leads. Therapeutic ultrasound is the use of ultrasound at higher energies than diagnostic ultrasound to bring heat or agitation into the body. Therapeutic ultrasound is acceptable if treatment is performed with a minimum separation distance of 15 cm (6 in) between the applicator and the implanted device and leads.
Vessel and tissue damage – Use care when positioning the lead. Avoid known infarcted or thin ventricular wall areas to minimize the occurrence of perforation and dissection.
Single use – The lead and accessories are for single use only.
Inspecting the sterile package – Inspect the sterile package
with care before opening it.
If the seal or package is damaged, contact a Medtronic representative.
Store at 25 °C (77 °F). Excursions from this storage temperature are permitted in the range of 15 to 30 °C (59 to 86 °F). (See USP Controlled Room Temperature.) According to USP excursion conditions, transient spikes up to 40 °C (104 °F) are permitted as long as they do not exceed 24 hours.
Do not use the product after its expiration date.
Sterilization – Medtronic has sterilized the package contents with ethylene oxide before shipment. This lead is for single use only and is not intended to be resterilized.
Steroid use – It has not been determined whether the warnings, precautions, or complications usually associated with injectable dexamethasone acetate apply to the use of this highly localized, controlled-release lead. For a list of potential adverse effects, refer to the Physicians’ Desk Reference.
Handling the steroid tip – Avoid reducing the amount of steroid available before implanting the lead. Reducing the available
amount of steroid may adversely affect low-threshold performance.
Do not allow the electrode surface to come in contact with surface contaminants.
Do not wipe or immerse the electrode in fluid, except blood, at the time of implant.
Handling a tined lead – Handle the lead with care at all times.
Do not implant the lead if it is damaged. Return the lead to a Medtronic representative.
Protect the lead from materials that shed small particles such as lint and dust. Lead insulators attract these particles.
Handle the lead with sterile surgical gloves that have been rinsed in sterile water or a comparable substance.
Do not severely bend, kink, or stretch the lead.
Do not immerse the lead in mineral oil, silicone oil, or any other liquid, except blood, at the time of implant.
Do not use surgical instruments to grasp the lead.
Do not force the lead if resistance is encountered during lead passage.
Handling the stylet – Handle the stylet with care at all times.
Curve the stylet before inserting it into the lead to achieve a curvature at the lead’s distal end. Do not use a sharp object to impart a curve to the distal end of the stylet.
Do not use excessive force or surgical instruments when inserting the stylet into the lead.
Avoid overbending or kinking the stylet.
Use a new stylet when blood or other fluids accumulate on the stylet. Accumulated blood or other fluids may damage the lead or cause difficulty in passing the stylet into the lead.
Necessary hospital equipment – Keep external defibrillation equipment nearby for immediate use during acute lead system testing, the implant procedure, or whenever arrhythmias are possible or intentionally induced during post-implant testing.
Magnetic resonance imaging (MRI) – An MRI is a type of medical imaging that uses magnetic fields to create an internal view of the body. Do not conduct MRI scans on patients who have this device or lead implanted. MRI scans may result in serious injury, induction of tachyarrhythmias, or implanted system malfunction or damage.
Concurrent devices – Output pulses, especially from unipolar devices, may adversely affect device sensing capabilities. If a patient requires a separate stimulation device, either permanent or temporary, allow enough space between the leads of the separate systems to avoid interference in the sensing capabilities of the devices. Previously implanted pulse generators and implantable cardioverter defibrillators should generally be explanted.
Chronic repositioning or removal of a tined lead – Proceed with extreme caution if a lead must be removed or repositioned. Chronic repositioning or removal of tined transvenous leads may be difficult because of fibrotic tissue development on the lead. In most clinical situations, it is preferable to abandon unused leads
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in place. Return all removed leads, unused leads, or lead sections to Medtronic for analysis.
Lead removal may result in avulsion of the endocardium, valve, or vein.
Lead junctions may separate, leaving the lead tip and bare wire in the heart or vein.
Chronic repositioning of a lead may adversely affect a steroid lead’s low-threshold performance.
An abandoned lead should be capped so that the lead does not transmit electrical signals.
Severed leads should have the remaining lead end sealed and the lead body sutured to adjacent tissue.
Connector compatibility – Although the lead conforms to the IS-1 International Connector Standard, do not attempt to use the lead with any device other than a commercially available implantable pacing system with which it has been tested and demonstrated to be safe and effective. The potential adverse consequences of using such a combination may include, but are not limited to, undersensing cardiac activity and failure to deliver necessary therapy.

6 Drug information

6.1 Mechanism of action

Steroid suppresses the inflammatory response that is believed to cause threshold rises typically associated with implanted pacing electrodes. Dexamethasone acetate is a synthetic steroid of the glucocorticoid family. Glucocorticoids have potent anti-inflammatory actions via direct and indirect effects on major inflammatory cells. Glucocorticosteroids bind to a cytoplasmic glucocorticoid receptor as well as a membrane-bound receptor. Binding to the cytoplasmic receptor leads to receptor activation and translocation to the nucleus. The receptor interacts with specific DNA sequences within the regulatory regions of affected genes. Thus, glucocorticoids inhibit the production of multiple cell factors that are critical in generating the inflammatory response.

6.2 Pharmacokinetics and metabolism

Pharmacokinetics – The pharmacokinetics (local drug levels
and systemic levels) of dexamethasone acetate and its metabolites following implant were not evaluated in human clinical trials. When delivered intra-muscularly, the lipid-soluble dexamethasone acetate is slowly absorbed throughout the tissue.
Metabolism – The conversion of dexamethasone acetate to dexamethasone occurs within hours. The dexamethasone alcohol (dexamethasone) is the active glucocorticoid used in this Medtronic lead. Steroid is applied via MCRD (Monolithic controlled release device) and eluted to the tissue interface where it will be used. The form of the steroid, whether it is a prodrug or the pharmacologically active dexamethasone, is irrelevant, as the steroid is directly present at the injury site to treat the inflammation. Dexamethasone acetate is hydrolyzed into dexamethasone, which is readily absorbed by the surrounding
tissue and body fluids. Glucocorticoids, when given systemically, are eliminated primarily by renal excretion of inactive metabolites.

6.3 Mutagenesis, carcinogenicity, and reproductive toxicity

Mutagenesis, carcinogenicity and reproductive toxicity –
The mutagenesis, carcinogenicity, and reproductive toxicity or the Model 4073 lead have not been evaluated. However, the mutagenesis, carcinogenicity, and reproductive toxicity of dexamethasone acetate has been evaluated previously.
Carcinogenesis, mutagenesis, and impairment of fertility –
No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis (tumor initiation or promotion). Dexamethasone was genotoxic in assays for clastogenicity (including sister chromatid exchange in human lymphocytes) but not in an assay for mutagenicity in salmonella (Ames test).
Adrenocorticoids have been reported to increase or decrease the number and mobility of spermatozoa in some patients.

6.4 Pregnancy

Pregnancy – Dexamethasone acetate has been shown to be
teratogenic in many species when given in doses equivalent to the human dose. There are no adequate and well-controlled studies in pregnant women. Dexamethasone acetate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Studies in mice, rats, and rabbits have shown that adrenocorticoids increase the incidence of cleft palate, placental insufficiency, and spontaneous abortions, and can decrease the intrauterine growth rate.
Nursing mothers – Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects in nursing infants. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to discontinue nursing or to use a non-steroidal lead, taking into account the importance of the lead and the drug to the mother.

6.5 Lactation

Corticosteroids are secreted into human milk and there is a potential for serious adverse reactions. A decision should be made whether to nurse or to discontinue the drug, taking into account the importance of the drug to the mother. These potential risks of corticosteroids should also be considered along with any other steroidal therapy being received by the patient.

7 Potential adverse events

The potential complications (listed in alphabetical order) related to the use of transvenous leads include, but are not limited to, the following patient-related conditions that can occur when the lead is being inserted or repositioned:
cardiac perforation
cardiac tamponade
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fibrillation and other arrhythmias
heart wall rupture
infection
muscle or nerve stimulation
pericardial rub
pneumothorax
thrombolytic and air embolism
thrombosis
valve damage (particularly in fragile hearts)
Other potential complications related to the tined lead and the programmed parameters include, but are not limited to, the complications listed in the following table. Symptoms of the following potential complications include loss of capture or intermittent or continuous loss of capture or sensing2:
Complication
Lead dislodgement Reposition the lead.
Lead conductor fracture or insula­tion failure
Threshold elevation or exit block Adjust the implantable device out-
Corrective action to be consid­ered
Replace the lead. In some cases with a bipolar lead, the implantable device may be programmed to a unipolar configuration or the lead may be unipolarized.
put. Replace or reposition the lead.
Potential acute or chronic complications associated with tined lead placement that may require lead replacement to correct include, but are not limited to, the following:
patient’s anatomy or physical condition. Each physician must apply the information in these instructions according to professional medical training and experience.

8.1 Opening the package

Within the sterile field, open the sterile package and remove the lead and accessories.

8.2 Using a stylet guide and stylets

Caution: To avoid lead tip distortion, keep the stylet fully inserted
into the lead during lead introduction and while advancing the lead. Keeping the stylet fully inserted into the lead is especially important while navigating through tortuous veins that may cause the stylet to “back out” of the lead.
Caution: To avoid damage to the stylet, do not use a sharp object to impart a curve to the distal end of a stylet (Figure 2).
The lead is packaged with the stylet guide attached to the connector pin and a stylet already inserted into the lead. If the stylet guide has been removed, replace it by gently pushing it as far as possible onto the connector pin (Figure 3).
Figure 2.
Implant technique Potential complication
Forcing the lead through the intro­ducer
Use of too medial of an approach with venous introducer resulting in clavicle and first rib binding
Puncturing the periosteum and/or tendon when using subclavian introducer approach
Advancing the lead into the venous insertion site and/or through the veins without the stylet fully inserted
Electrode damage, tine damage, insulation damage
Conductor coil fracture, insulation damage
Conductor coil fracture, insulation damage
Tip distortion, insulation perfora­tion
Use the stylet guide to insert a stylet into the lead. If a slight curve is needed for the stylet, use only a smooth object to impart a curve to the distal portion of a stylet (Figure 2).
Figure 3.

8 Directions for use

Proper surgical procedures and sterile techniques are the responsibility of the medical professional. The following procedures are provided for information only. Some implantation techniques vary according to physician preference and the
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Transient loss of capture or sensing may occur for a short time following surgery until lead stabilization takes place. If stabilization does not occur, lead dislodgement may be suspected.
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8.3 Selecting an insertion site

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Caution: When using a subclavian approach, insert the lead
using a more lateral approach to minimize the risk of first rib clavicular crush. First rib clavicular crush may subsequently fracture the lead body.
Caution: Certain anatomical abnormalities, such as thoracic outlet syndrome, may pinch and subsequently fracture the lead body.
The lead may be inserted by venotomy through several different venous routes, including the right or left cephalic vein, other subclavian branches, or the external or internal jugular vein. The lead may also be inserted into a subclavian vein through a percutaneous lead introducer (PLI). Select the desired entry site (Figure 4).
Note: If wiping the lead is necessary before insertion, ensure that the anchoring sleeve remains in position.
Figure 4.
1 Suggested entry site

8.4 Using the vein lifter

1. Advance the lead into the right atrium.
2. Use fluoroscopy to facilitate accurate lead placement.
3. Rotate and pass the lead through the tricuspid valve. Rotating the lead or stylet eases passage of the lead as it is advanced through the tricuspid valve or its chordae tendineae. Note: For added control in maneuvering the lead tip through the tricuspid valve, curve the distal end of the lead slightly by inserting a gently curved stylet. Refer to Section 8.2 for instructions about imparting a curve to a stylet. The lead tip may then be directly advanced through the valve, or it may be projected against the lateral atrial wall with the curved portion of the lead backed across the tricuspid valve.
4. If using a curved stylet, replace the curved stylet with a straight stylet after the lead tip is passed into the right ventricle.
5. Withdraw the stylet slightly or back the distal lead tip out of the pulmonary outflow tract to avoid using excessive tip force while achieving the final electrode position.
6. Use fluoroscopy (lateral position) to ensure that the tip is not in a retrograde position or is not lodged in the coronary sinus.
Accurate positioning and wedging of the electrode is essential for stable pacing and sensing. A satisfactory position is achieved when the lead tip points straight toward the apex or when the distal end dips or bends slightly (Figure 6).
Figure 6.
Caution: Use care when handling the lead during insertion. Avoid
placing the lead under extreme tension or angulation to prevent possible lead fracture. Avoid gripping the lead with surgical instruments.
Use the vein lifter:
1. Insert the tapered end of the vein lifter into the incised vein (Figure 5).
Figure 5.
2. Gently push the lead tip underneath the vein lifter and into the vein.

8.5 Positioning a tined ventricular lead

Warning: To minimize the occurrence of perforation and
dissection, avoid known infarcted or thin ventricular wall areas.
Position a tined ventricular lead:

8.6 Taking electrical measurements

Take electrical measurements:
1. Attach the clip of a surgical cable to the notch on the stylet guide (Figure 7).
Figure 7.
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Note: A unipolar lead requires the use of an indifferent electrode.
2. Use an implant support instrument to obtain electrical measurements. Medtronic recommends using a pacing system analyzer. For information on the use of the implant support instrument, see the product literature for that device. Satisfactory lead placement is indicated by low stimulation thresholds and adequate sensing of intracardiac signal amplitudes. Refer to Table 1 for recommended stimulation threshold and sensing amplitude measurements at implant.
A low stimulation threshold provides for a desirable safety margin, allowing for a possible rise in thresholds that may occur within 2 months following implant.
Adequate sensing amplitudes ensure that the lead is properly sensing intrinsic cardiac signals. Minimum signal requirements depend on the device’s sensitivity capabilities. Acceptable acute signal amplitudes for the lead must be greater than the minimum device sensing capabilities, including an adequate safety margin to account for lead maturity.

Table 1. Recommended measurements at implant

Ventricle Atrium
Maximum acute stimulation thresholds
Minimum acute sensing amplitudes 5.0 mV 2.0 mV
a
At pulse duration setting of 0.5 ms.
a
1.0 V
3.0 mA
1.5 V
4.5 mA
3. If electrical measurements do not stabilize to acceptable levels, repositioning the lead and repeating the testing procedure may be necessary. Note: Initial electrical measurements may deviate from the recommendations because of acute cellular trauma. If such a deviation occurs, wait 5 to 15 min and repeat the testing procedure. Values may vary depending upon lead type, device settings, cardiac tissue condition, and drug interactions.

8.6.1 Checking diaphragmatic stimulation for tined leads

Diaphragmatic stimulation should also be checked by pacing at 10 V and a pulse width setting greater than 0.5 ms and observing for diaphragmatic contracting either by fluoroscopy or direct abdominal palpitation. This should be checked for both atrial and ventricular leads. Further testing may include patient positional changes to simulate upright chronic conditions.
If diaphragmatic pacing occurs, reduce the voltage until a diaphragmatic pacing threshold is determined. A diaphragmatic threshold of 5 to 6 V or less usually necessitates repositioning of the lead.

8.6.2 Taking pacing impedance (or resistance) measurements

Pacing impedance (or resistance) is used to assess device function and lead integrity during routine device patient follow-up sessions and to assist in troubleshooting suspected lead failures.
Additional troubleshooting procedures include ECG analysis, visual inspection, measurement of thresholds, and electrogram characteristics.
Pacing impedance values are affected by many factors including lead position, electrode size, conductor design and integrity, insulation integrity, and the patient’s electrolyte balance. Apparent pacing impedance is also significantly affected by the measurement technique. Comparison of pacing impedance should be done using consistent methods of measurements and equipment.
An impedance higher or lower than the typical values is not necessarily a conclusive indication of a lead failure. Other causes must be considered as well. Before reaching a conclusive diagnosis, the full clinical picture must be considered. The full clinical picture includes pacing artifact size and morphology changes in 12-lead analog ECGs, muscle stimulation with bipolar leads, sensing and/or capture problems, patient symptoms, and device characteristics.
Recommendations for clinically monitoring and evaluating leads in terms of impedance characteristics are listed below.
Consider the following recommendations for devices with telemetry readout of impedance:
Routinely monitor and record impedance values at implant and follow-up sessions using consistent output settings. Note: Impedance values may be different at different programmable output settings (for example, pulse width or pulse amplitude) of the device or pacing system analyzer.
Establish a baseline chronic impedance value once the impedance has stabilized, generally within 6 to 12 months after implant.
Monitor for significant impedance changes and abnormal values.
Where impedance abnormalities occur, closely monitor the patient for indications of pacing and sensing problems. The output settings used for measuring impedance should be the same as those used for the original measurements.
For patients at high risk, such as implantable device-dependent patients, physicians may want to consider further action such as increased frequency of monitoring, provocative maneuvers, and ambulatory ECG monitoring.
Consider the following recommendations for devices without telemetry:
Record the impedance value at implant. Also record the measurement device, its output settings, and the procedure used.
At the time of device replacement, if pacing system analyzer-measured impedance is abnormal, carefully evaluate lead integrity (including thresholds and physical appearance) and patient condition before electing to reuse the lead.
Impedances below 250 Ω may result in excessive battery current drain, which may seriously compromise device longevity, regardless of lead integrity.
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For more information on obtaining electrical measurements,
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consult the product literature supplied with the testing device.

8.7 Anchoring the lead

Cautions:
Use care when anchoring the lead.
Use an anchoring sleeve with all leads.
Do not use absorbable sutures to anchor the lead.
Do not secure the sutures so tightly that they damage the vein, lead, or anchoring sleeve.
Do not use the anchoring sleeve tabs for suturing (Figure 8).
Do not tie a suture directly to the lead body (Figure 9).
Do not dislodge the lead tip.
Do not attempt to remove or cut the anchoring sleeve.
Do not remove the tabs on anchoring sleeves. Tabs are provided to minimize the possibility of the sleeve entering the vein.
If using a large diameter percutaneous lead introducer (PLI) sheath, extreme care should be taken to prevent passage of the anchoring sleeve into the PLI lumen or the venous system.
Figure 8.
1 Anchoring sleeve tab
Figure 9.
Figure 10.
5. If anchoring with all 3 grooves, use the most proximal groove to secure the anchoring sleeve to the lead body (Figure 11).
Figure 11.

8.8 Connecting the lead

Caution: Always remove the stylet and stylet guide before
connecting the lead to the device. Failure to remove the stylet and stylet guide may result in lead failure.
Connect the lead to the device:
1. Carefully and completely remove the stylet and stylet guide. Note: When removing the stylet and stylet guide, firmly grip the lead just below the connector pin to help prevent possible lead dislodgement.
2. Obtain final electrical measurements.
3. Insert the lead connector into the connector block on the device. For instructions on proper lead connections, see the product documentation supplied with the device.

8.9 Placing the device and lead into the pocket

With a triple groove anchoring sleeve, generally 2 or 3 of the grooves may be used with the following procedure.
Anchor the lead:
1. Position the anchoring sleeve close to the lead’s connector pin to prevent inadvertent passage of the sleeve into the vein.
2. Insert the anchoring sleeve partially into the vein.
3. Use the most distal suture groove to secure the anchoring sleeve to the vein.
4. Use the middle groove to secure the anchoring sleeve to the fascia and lead (Figure 10):
a. Create a base by looping a suture through the fascia
underneath the middle groove and tying a knot.
b. Firmly wrap the suture around the middle groove and tie
a second knot.
Cautions:
Use care when placing the device and lead into the pocket.
Ensure that the lead does not leave the device at an acute angle.
Do not grip the lead or device with surgical instruments.
Do not coil the lead (Figure 12). Coiling the lead can twist the lead body and may result in lead dislodgement.
Figure 12.
Caution: To prevent undesirable twisting of the lead body, wrap
the excess lead length loosely under the device and place both the device and the lead into the subcutaneous pocket.
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Place the device and lead into the pocket:
1. Rotate the device to loosely wrap the excess lead length under the device (Figure 13).
Figure 13.
2. Insert the device and lead into the pocket.
3. Suture the pocket closed.
4. Monitor the patient’s electrocardiogram until the patient is discharged. If a lead dislodges, it usually occurs during the immediate postoperative period.

8.10 Post-implant evaluation

After implant, monitor the patient’s electrocardiogram until the patient is discharged. If a lead dislodges, it usually occurs during the immediate postoperative period.
Recommendations for verifying proper lead positioning include x-rays and pacing and sensing thresholds taken at pre-hospital discharge, 3 months after implant, and every 6 months thereafter.
In the event of a patient death, explant all implanted leads and devices and return them to Medtronic with a completed Product Information Report form. Call the appropriate phone number on the back cover if there are any questions on product handling procedures.
Parameter Model 4073
Tip electrode: 1.6 mm
Lead introducer (recommended size)
without guide wire: 2.3 mm (7 French)
with guide wire: 2.6 mm (8 French)
Electrode surface area
Resistance 40 Ω (58 cm)
Steroid Dexamethasone acetate
Amount of steroid 272 µg (target dosage)
Steroid binder Silicone
Tip 2.5 mm
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9 Specifications

Parameter Model 4073
Type Unipolar
Chamber Ventricle
Fixation 4 tines, each 2.5 mm in length
Lengths 20-110 cm
Connector IS-1 UNI
Material Conductor: MP35N nickel alloy
Connector pin: Stainless steel
Connector ring: Stainless steel
Insulator: Polyurethane
Tip electrode: Titanium nitride coated platinum
Tip electrode configuration Ring-shaped, porous, titanium
Diameters Lead body: 1.2 mm
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alloy
Tines: Polyurethane
nitride coated, steroid-eluting
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Figure 14.

10 Medtronic warranty

For complete warranty information, see the accompanying warranty document.

11 Service

Medtronic employs highly trained representatives and engineers located throughout the world to serve you and, upon request, to provide training to qualified hospital personnel in the use of Medtronic products. Medtronic also maintains a professional staff to provide technical consultation to product users. For more information, contact your local Medtronic representative, or call or write Medtronic at the appropriate telephone number or address listed on the back cover.
1 Lead length: 20-110 cm 2 Tip electrode; surface area: 2.5 mm 3 Insulation material: polyurethane 4 Connector: IS-1 UNI
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World Headquarters
*M954534A001*
Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com Tel. +1 763 514 4000 Fax +1 763 514 4879
Medtronic USA, Inc.
Toll-free in the USA (24-hour technical consultation for physicians and medical professionals) Bradycardia: +1 800 505 4636 Tachycardia: +1 800 723 4636
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Medtronic E.C. Authorized Representative
Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel. +31 45 566 8000 Fax +31 45 566 8668
Technical manuals: www.medtronic.com/manuals
© Medtronic, Inc. 2013 M954534A001A 2013-02-17
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