Medtronic 5554-45 Technical Manual

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CAPSURE Z
Steroid eluting, bipolar, implantable, tined, atrial, transvenous lead
®
NOVUS 5554
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 are trademarks of Medtronic: CapSure, CapSure Z, Medtronic
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Contents

1 Description 3 2 Indications 3 3 Contraindications 3 4 Warnings and precautions 3 5 Potential complications 4 6 Implant procedure 5 7 Specifications (nominal) 9 8 Medtronic warranty 9 9 Service 9

1 Description

The Medtronic CapSure Z Novus Model 5554 steroid eluting, bipolar, implantable, tined, atrial, transvenous lead features a tip electrode with a hemispherical microporous surface composed of platinum that has been coated with the steroid dexamethasone sodium phosphate. The ring electrode is composed of platinum alloy.
The tip electrode contains a maximum of 1.0 mg of dexamethasone sodium phosphate, a portion of which is in a silicone rubber binder. 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 distal portion of the lead is J-shaped. This facilitates placement of the electrode in or near the apex of the right atrial appendage.
The lead size is reduced from current Medtronic bipolar leads due to a change in the silicone insulation material. This correlates to a smaller lead body. These leads use a 7 French introducer or a 9 French introducer with guide wire.
The lead also features four polyurethane tines near the electrode tip, MP35N nickel alloy conductors, silicone rubber insulation, and an IS-1 Bipolar (BI)

1.1 Package contents

Leads 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 literature
1
IS-1 BI refers to an International Connector Standard (ISO 5841-3) whereby pulse generators and leads so designated are assured of a basic mechanical fit.
1
lead connector.

1.2 Accessory descriptions

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 Indications

The Model 5554 lead is designed to be used with a pulse generator as part of a cardiac pacing system. The lead has application where implantable atrial, single chamber or dual chamber pacing systems are indicated.

3 Contraindications

Use of atrial tined transvenous leads may be
contraindicated in the absence of a right atrial appendage. Use of steroid eluting transvenous leads is
contraindicated in patients for whom a single dose of
1.0 mg dexamethasone sodium phosphate may be contraindicated.

4 Warnings and precautions

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 – People with metal implants such as pacemakers, implantable cardioverter defibrillators (ICDs), and accompanying leads should not receive diathermy treatment. The interaction between the implant and diathermy can cause tissue damage, fibrillation, or damage to the device components, which could result in serious injury, loss of therapy, and/or the need to reprogram or replace the device.
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 is for single use only. Inspecting the sterile package – Inspect the sterile package
with care before opening it.
Contact a Medtronic representative if the seal or package
is damaged. Do not store this product above 40 C˚ (104 F˚).
Do not use the product after its expiration date.
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Ethylene oxide resterilization – The lead has been sterilized with ethylene oxide before shipment. If the sterile package seal is broken before the lead’s expiration date, resterilize using only a validated ethylene oxide resterilization process. The lead should not be autoclaved or sterilized by gamma radiation and should not be cleaned in ultrasonic cleaners.
Refer to sterilizer instructions for operating instructions.
Place the lead in an ethylene oxide permeable package
before resterilization. Do not exceed temperatures of 55 C˚ (131 F˚).
Do not resterilize more than one time.
Use an acceptable method to determine sterilizer
effectiveness, such as biological indicators. Allow the lead to aerate ethylene oxide residues before
implant and after resterilization.
Steroid use – It has not been determined whether the warnings, precautions, or complications usually associated with injectable dexamethasone sodium phosphate 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.
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 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.

5 Potential complications

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
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)
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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 sensing
Complication
Lead dislodgement Reposition the lead. Lead conductor fracture or
insulation failure
Threshold elevation or exit block Adjust the implantable device
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.
output. Replace or reposition the lead.
2
:
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:
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

6 Implant procedure

Proper surgical procedures and sterile techniques are the responsibility of the medical professional. Some implant techniques vary according to physician preference and the patient’s anatomy or physical condition.

6.1 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 1).
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Transient loss of capture or sensing may occur for a shor t time following surgery until lead stabilization takes place. If stabilization does not occur, lead dislodgement may be suspected.
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 2).

Figure 1.

Use the stylet guide to inser t 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 1).

Figure 2.

6.2 Selecting an insertion site

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 inser ted into a subclavian vein through a percutaneous lead introducer (PLI). Select the desired entry site (Figure 3).
Note: If wiping the lead is necessary before insertion, ensure that the anchoring sleeve remains in position.
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Figure 3.

1
1 Suggested entry site

6.3 Using the vein lifter

Caution: Use care when handling the lead during inser tion.
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. Inser t the tapered end of the vein lifter into the incised vein (Figure 4).

Figure 4.

2. Gently push the lead tip underneath the vein lifter and into the vein.

6.4 Positioning a tined atrial J-shaped lead

Note: For improved maneuverability through the vein, insert
a straight stylet into the lead to straighten the J-portion of the lead.
Position a tined atrial J-shaped lead:
1. Advance the lead into the right atrium.
2. Use fluoroscopy to facilitate accurate lead placement.
3. Position the lead tip in the right atrium just above the tricuspid valve.
4. Withdraw the stylet partially so that the lead assumes its natural J-shape.
5. Maneuver the lead using fluoroscopy so that the tip faces forward (anterior) and slightly to the patient’s left until the tip enters and becomes lodged in the atrial appendage.
Note: At this point, further retraction of the lead will cause the J-portion to open.
6. Check the position of the lead’s distal tip by twisting the lead body at the vein entry site approximately one clockwise turn and then one counterclockwise turn.
7. Use fluoroscopy to ensure that the J-portion of the lead is moving back and forth while the electrode remains stable. Note: If the lead tip changes position or flops back and forth, it is likely that the electrode is not properly lodged into the atrial appendage.
8. Adjust the lead tension so that the J-portion is snug during maximal exhalation and opens to almost an L-shape during deep inhalation.
Accurate positioning and wedging of the electrode are essential for stable pacing and sensing. Generally, a satisfactory position has the lead tip situated against the atrial endocardium in or near the apex of the appendage. As viewed on fluoroscopy (A-P view), the lead tip points medially and forward toward the left atrium (Figure 5). A lateral view will show the opening of the J-portion facing the patient’s sternum.

Figure 5.

If properly positioned, the lead tip will sway from side to side with each atrial contraction (viewed under A-P fluoroscopy). In the absence of spontaneous atrial activity, movement can be produced by pacing the atrium through the lead.

6.5 Taking electrical measurements

Take electrical measurements:
1. Attach the clip of a surgical cable to the notch on the stylet guide (Figure 6).

Figure 6.

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.
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Satisfactory lead placement is indicated by low stimulation thresholds and adequate sensing of intracardiac signal amplitudes.
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.

Tab le 1 . Recommended measurements at implant

Measurement required 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.
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 minutes and repeat the testing procedure. Values may vary depending upon lead type, device settings, cardiac tissue condition, and drug interactions.

6.5.1 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.

6.5.2 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 and to assist in troubleshooting suspected lead failures. Additional troubleshooting procedures include ECG analysis, visual inspection, measurement of thresholds, and electrogram characteristics.
a
1.0 V
3.0 mA
1.5 V
4.5 mA
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-ups 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 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
current drain, which may seriously compromise device longevity, regardless of lead integrity.
For more information on obtaining electrical measurements, consult the product literature supplied with the testing device.
may result in excessive battery
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6.6 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 7). Do not tie a suture directly to the lead body (Figure 8).
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 7.

1
1 Anchoring sleeve tab

Figure 8.

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. Inser t 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 9): 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.

Figure 9.

5. If anchoring with all three grooves, use the third and most proximal groove to secure the anchoring sleeve to the lead body (Figure 10).

Figure 10.

6.7 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 according to the instructions in the product literature supplied with the device.
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. Inser t the lead connector into the connector block on the device. For instructions on proper lead connections, see the product literature supplied with the device.

6.8 Placing the device and lead into the pocket

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 11). Coiling the lead can twist
the lead body and may result in lead dislodgement.

Figure 11.

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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.
Place the device and lead into the pocket:
1. Rotate the device to loosely wrap the excess lead length under the device (Figure 12).

Figure 12.

Parameter Model 5554
Bipolar: 51 (53 cm)
Tip to ring spacing
Steroid Dexamethasone sodium
Amount of steroid 1.0 mg maximum Steroid binder Silicone rubber
17 mm
phosphate

8 Medtronic warranty

For complete warranty information, see the accompanying warranty document.
2. Inser t 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.
7 Specifications (nominal)
Parameter Model 5554
Type Bipolar Chamber Atrium Fixation 4 tines, each 2.5 mm in length Length Connector IS-1 BI Material Conductor: MP35N nickel alloy
Connector
Connector
Insulator: Silicone rubber
electrode:
electrode:
Tip electrode configuration Hemispherical, platinized,
Diameters Lead body:
electrode:
electrode:
Lead introducer (recommended size)
without guide
with guide
Electrode surface area
Resistance Unipolar: 37 (53 cm)
20–110 cm
Stainless steel
pin:
Stainless steel
ring:
Ring
Polished platinum alloy
Tip
Platinum
Tines: Polyurethane
porous, steroid eluting
2.0 mm
2.1 mm
Ring
1.0 mm
Tip
7 French (2.3 mm)
wire:
9 French (3.0 mm)
wire:
Ring:
Tip:
36 mm
1.2 mm
2
2

9 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 medical consultation, Medtronic can often refer product users to outside medical consultants with appropriate expertise. For more information, contact your local Medtronic representative, or call or write Medtronic at the appropriate address or telephone number listed on the back cover.
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World Headquarters
Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432-5604 USA Internet: www.Medtronic.com Tel. 763-514-4000 Fax 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 Heart Failure: 1-800-505-4636
Europe/Africa/Middle East Headquarters
Medtronic Europe Sàrl Route du Molliau 31 Case Postale CH-1131 Tolochenaz Switzerland Internet: www.Medtronic.co.uk Tel. 41-21-802-7000 Fax 41-21-802-7900
Medtronic E.C. Authorized Representative/ Distributed by
Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel. 31-45-566-8000 Fax 31-45-566-8668
Asia
Medtronic International Ltd. Suite 1602 16/F, Manulife Plaza The Lee Gardens, 33 Hysan Avenue Causeway Bay, Hong Kong Tel. 852-2891-4068 Fax 852-2591-0313
Australia
Medtronic Australasia Pty. Ltd. Unit 4/446 Victoria Road Gladesville NSW 2111 Australia Tel. 61-2-9879-5999 Fax 61-2-9879-5100
Canada
Medtronic of Canada Ltd. 6733 Kitimat Road Mississauga, Ontario L5N 1W3 Tel. 905-826-6020 Fax 905-826-6620 Toll-free in Canada: 1-800-268-5346
Japan
Medtronic Japan Solid Square West Tower 6F, 580 Horikawa-cho, Saiwai-ku Kawasaki, Kanagawa 210-0913 Japan Tel. 81-44-540-6112 Fax 81-44-540-6200
Technical manuals: www.Medtronic.com/manuals
© Medtronic, Inc. 2005 A03381001B 2005-11-02
*A03381001*
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