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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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