Medtronic 6416-200 Technical Manual

6416

Temporary transvenous pacing lead system

Technical Manual

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

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are the property of their respective owners.

Medtronic

Contents

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

10 Explanation of symbols on package labeling 7

1 Description

The Medtronic Model 6416 Temporary, Transvenous Pacing Lead
System features an active fixation, bipolar lead and a soft-tipped,
lubricated guide catheter. The system is designed for temporary
intracardiac pacing and/or EGM recording.

1.1 Package contents

Dispose of the lead and all single-use accessories according to
local environmental requirements.

The lead and accessories are supplied sterile. Each package
contains the following items:

●

Product documentation

●

Individually packaged, sterile temporary lead systems. Refer
to the shelf box for the packaged quantity.
– one temporary active fixation lead with torque tool
– one 2.08 mm (6 French) lubricated guide catheter
– one “Y” adaptor with hemostasis valve
– one lead safety label (sticker)

Figure 1. Model 6416 Temporary Transvenous Pacing Lead System

1 "Y" adaptor with hemostasis valve
2 Lubricated guide catheter

3 Torque tool
4 Temporary lead
5 Active fixation

1.2 Accessory descriptions

Torque tool – The torque tool assists helix fixation by rolling

between the thumb and forefinger.

Lead safety label – Used as a reference for explant. The lead
safety label may be affixed to the lead, the bandage, or the patient
chart.

2 Indications

The Medtronic 6416 Temporary, Transvenous Pacing Lead
System features an active fixation, bipolar lead and a soft-tipped,
lubricated guide catheter. The system is designed for temporary
intracardiac pacing and EGM recording.

The system is disposable, for temporary single patient use, with a
contemplated implant duration of 7 days or less. The lead and
accessories are supplied sterile.

The lead is introduced transvenously using the guide catheter.
Once within the appropriate chamber, the helical tip electrode of
the lead is actively fixed into the endocardium. After lead
placement the guide catheter is removed by sliding it over the
lead’s bifurcated connector.

3 Contraindications

●

Patients with sepsis or with a hypercoagulable state should
not be considered for transvenous leads.

●

Patients with a mechanical valve in the tricuspid position
should not be considered for ventricular placement.

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.

Unintentional contact – Avoid the possibility of unintentional
contact between the lead(s), including extension cables, and any
equipment used, as well as any conductive surface contact.

Equipment and accessories – Equipment and accessories
connected to the Model 6416 shall comply with IEC 60601-1, type
CF.

Diathermy treatment (including therapeutic ultrasound) –

Diathermy is a treatment that involves the therapeutic heating of
body tissues. Diathermy treatments include high frequency, short

3

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 lead system.
Therapeutic ultrasound (including physiotherapy, high intensity
therapeutic ultrasound, and high intensity focused 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 lead system, as long as the ultrasonic beam
is pointing away from the device and lead system.

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.

Single use – This device is intended only to be used once for a
single patient. Do not reuse, reprocess, or resterilize this device
for purpose of reuse. Reuse, reprocessing, or resterilization may
compromise the structural integrity of the device or create a risk of
contamination of the device that could result in patient injury,
illness, or death.

Inspecting the sterile package – Inspect the sterile package
with care before opening it.

●

Contact a Medtronic representative if the seal or package is
damaged.

●

The product should not be exposed to temperatures
below -35 °C (-31 °F) and above 58 °C (136 °F).

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.

Handling the lead – Handle the lead with care at all times.

●

Do not severely bend, kink, or stretch the lead or guide
catheter, and do not grip with surgical instrument or use
excessive force during insertion.

●

Do not wipe the lead with chloro-fluoro carbon (CFC) based
solvents.

Protecting exposed lead pins – To avoid the potential for an
electrical shock being delivered to the patient’s heart after the lead
has been implanted, the connector pins must be connected to an
external pulse generator (EPG) or EPG cable.

Guide catheter – Removal of the guide catheter is recommended
once satisfactory placement of the lead has been achieved.

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.

Equipment modification – Do not modify the temporary lead.
Modifications could impact the temporary lead effectiveness and
adversely affect patient safety.

Disposal of temporary pacing lead – Dispose of the temporary
pacing lead according to hospital biohazard requirements. If
returning the lead, contact your local Medtronic representative.

Lead safety label – Apply the lead safety label (sticker) to the
lead for reference during the explant procedure. The active
fixation lead must be removed properly to avoid tissue damage.

5 Potential complications

The potential complications (listed in alphabetical order) related
to the use of this lead include, but are not limited to, the following
patient-related conditions that can occur when the lead is being
inserted or repositioned:

●

arrhythmias

●

arteriovenous fistula formation

●

cardiac perforation

●

cardiac tamponade

●

damage to vessel or valve structures

●

endocarditis

●

lead dislodgement

●

muscle or nerve stimulation

●

pneumothorax

●

sepsis and infection

●

thrombosis and thrombophlebitis

6 Suggested insertion procedure

Although a variety of techniques can be used, the following
guidelines are provided as an aid to the physician.

Note: An ECG recording system should be attached to the patient
prior to beginning the procedure to facilitate monitoring for
arrhythmias.

6.1 Preparation

1. Attach the "Y" adaptor with hemostasis valve to the proximal
end of the guide catheter.

2. Position the lead inside the guide catheter so that the helix
depth marker and rotation indicator are fully visible (see
Figure 2).

Figure 2. Lead markers

1 Rotation indicator
2 Helix depth marker

4

3. Close the hemostasis valve around the lead body by turning
the knurled knob until resistance is felt. Do not use a tool to
tighten the hemostasis valve.

6.2 Inserting the guide catheter and lead

Use fluoroscopy to facilitate accurate lead placement.

1. Introduce the guide catheter and lead into the vein by
cutdown, or by use of a percutaneous catheter introducer or
needle cannula.

Figure 3. Aligning the helix

1 Ring electrode
2 Guide catheter

2. Advance the guide catheter and lead together [with the helix
of the lead inside the guide catheter (see Figure 3)], through
the vein and into the heart until the fluoroscope shows the
guide catheter in a desirable position for lead placement.

3. Gently press the guide catheter tip against the endocardium.

6.3 Securing the electrode to the endocardium

Caution: Do not over rotate the lead, as the helix may be lodged

in the heart tissue with excessive force. This may cause tissue
damage or may cause the distal lead section to fracture upon
removal of the lead. To minimize the occurrence of perforation,
avoid known infarcted or thin wall areas.

1. Loosen the hemostasis valve. Advance the lead and retract
the guide catheter until the edge of the hemostasis valve is
between the two lead markings (see Figure 4).

Figure 4. Aligning the guide catheter

3. Apply gentle forward pressure while rotating the lead
clockwise 2 to 5 turns, depending upon its length (see
Chapter 7, “Specifications (nominal)”, page 6 ). Use the
rotation indicator to count rotations.

4. Verify fixation with fluoroscopy and/or gentle traction.

5. Slide the guide catheter back to expose the ring electrode,
and check the pacing threshold.
Note: An atypically high pacing threshold may indicate that
the guide catheter is covering the ring electrode.

6. If the lead needs to be repositioned, remove the lead (see
Section 6.6, “Removing the lead”, page 6 ), and inspect
the helix. Biopsy or a deformed helix may inhibit re-fixation.

Note: Rotate the lead counter-clockwise while removing it.

6.4 Removing the guide catheter and securing the lead

Upon successful insertion:

1. Hold the lead between the torque tool and hemostasis valve,
and gently peel the torque tool away from the lead body (see
Figure 5). Grasp the end of the torque tool that is closest to
the hemostasis valve.
Note: These techniques will help avoid lead dislodgement.

2. Open the hemostasis valve if it is closed.

3. Feed the lead into the guide catheter while withdrawing the
guide catheter.

4. Loop the lead and secure it at the insertion site using aseptic
technique.
Note: Be sure to leave enough intravascular slack to allow for
patient movement.

Figure 5. Removing the torque tool

1 Rotation indicator
2 Torque tool
3 Helix depth marker

2. Grip the torque tool in one hand and hold the guide catheter
in the other. The torque tool is positioned adjacent to, or
slightly overlapping, the rotation indicator (see Figure 4).

6.4.1 Lead safety label

Affix the enclosed lead safety label/sticker (see Figure 6) to the
lead as a reference for explant and as a mechanism for chamber
identification.

Figure 6. Lead safety label

6.5 Connecting the lead to the temporary pacemaker

Note: Verify cable to pulse generator compatibility before use.

5

1. Connect the patient cable or surgical cable to the appropriate
terminal(s) on the temporary pacemaker. Observe polarity
and chamber designations.

2. Connect the positive (+) electrode of the lead (see Figure 7)
to the positive(+) terminal of a patient cable or surgical cable.
Connect the negative (-) electrode to the negative (-)
terminal. Observe polarity and chamber designations.

Figure 7. Connector pins

1 Positive (+) electrode
2 Negative (-) electrode

Note: Do not over-tighten the patient cables when attaching
the lead to the pacing generator, as it may damage the lead.

3. Verify the threshold.

6.6 Removing the lead

Upon completion of temporary pacing therapy:

1. Apply gentle traction to the lead.

2. While applying gentle traction, rotate the lead
counterclockwise 2-5 turns to disengage the helix from the
endocardium.

3. Carefully slide the lead out of the vein.

7 Specifications (nominal)

Parameter Model 6416

Guide Cathe­ter

Length 40, 60, or 90 cm

Material PEBA (Polyether Block Amide)

Diameter

Inner: 1.80 mm (5.5 French)

Outer: 2.08 mm (6.0 French)

Lead

Type Bipolar

Chamber Atrium/Ventricle

Fixation Active, screw-in

Length 100 cm (femoral, subclavian, jugular)

140 cm (femoral, subclavian, jugular)

200 cm (femoral)

Connector Bifurcated, pull-through

Material

Conductor: Stainless steel

Insulation: Polyethylene

Helix: Stainless steel

Parameter Model 6416

Ring: Stainless steel

Diameter 1.18 mm (3.5 French)

Helix length 0.8 mm

Proximal pins

Diameter: 0.8 mm

Length: 20.3 mm

Electrode
surface area

Tip: 4.3 mm

Ring: 17.2 mm

Distance
between
electrodes

Resistance

100 cm Inner wire (tip): 55 Ω maximum

140 cm Inner wire (tip): 75 Ω maximum

200 cm Inner wire (tip): 105 Ω maximum

Recommen­ded revolu­tions to
embed the
helix

Lead length Revolutions

100 cm 2-3

140 cm 3-4

200 cm 4-5

Storage tem­perature

2

2

1 cm

Outer wire (ring): 33 Ω maximum

Outer wire (ring): 45 Ω maximum

Outer wire (ring): 63 Ω maximum

-35 °C to 58 °C (-31 °F to 136 °F)

6

Figure 8.

9 Medtronic warranty

For complete warranty information, see the accompanying
warranty document.

10 Explanation of symbols on package labeling

Refer to the package labels to see which symbols apply to this
product.

Table 1. Explanation of symbols on package labeling

Symbol Explanation

Use by

Lot number

Reorder number

Sterilized using ethylene oxide

Do not reuse

Lead length

Temperature limitation

1 Outer diameter of catheter 2.08 mm (6.0 French)
2 Inner diameter of catheter 1.80 mm (5.5 French)
3 Catheter length 40, 60, 90 cm
4 Tip electrode surface area 4.3 mm
5 Ring electrode surface area 17 mm
6 Lead body diameter 1.18 mm (3.5 French)
7 Connector pin diameter 0.8 mm
8 Distance between electrodes 1 cm
9 Lead length 100, 140, 200 cm

10 Connector pin length 20.3 mm

2

2

8 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.

Do not use if package is damaged

Package contents

Consult instructions for use

Lead

Product Documentation

Transvenous ventricular lead

Transvenous atrial lead

Catheter

7

Table 1. Explanation of symbols on package labeling (continued)

Symbol Explanation

Torque tool

Retractable screw-in

“Y” adaptor with hemostasis valve

Catheter delivered

Outer diameter

Humidity limitation

Defibrillation-proof type CF applied part

Follow instructions for use (blue)

Bipolar connector

8

Medtronic, Inc.

*M956206A001*

710 Medtronic Parkway
Minneapolis, MN 55432
USA
www.medtronic.com
[phone]

Medtronic USA, Inc.

Toll-free in the USA (24-hour technical consultation for
physicians and medical professionals)
Bradycardia: [phone]
Tachycardia: [phone]

Europe/Middle East/Africa

Medtronic International Trading Sàrl
Route du Molliau 31
Case Postale 84
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[phone]

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© 2015 Medtronic, Inc.
M956206A001 C
2015-07-07