Medtronic 5554-45 Technical Manual

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.

The following are trademarks of Medtronic:
CapSure, CapSure Z, Medtronic

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.

•

3

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)

•

4