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Temporary Pacing Leads
| 6416 Temporary Transvenous Pacing
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Intended Use
The 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. 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.
Contraindications
Patients with sepsis or a hypercoagulable state. Patients with a
mechancial valve in the tricuspid position should not be considered
for ventricular placement.
Warnings
An inserted lead forms a direct current path to the myocardium.
During lead insertion 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.
Potential Complications
Arrhythmias, endocarditis, pneumothorax, cardiac perforation, cardiac
tamponade, muscle or nerve stimulation, sepsis/infection, thrombosis,
atriovenous fistula formation, damage to vessel or valve structures,
lead dislodgement.
Precautions
Do not severely bend, kink, or stretch the lead or guide catheter,
and do not grip with surgical instruments or use excessive force
during insertion. Do not wipe the lead with chlorofluorocarbon-based
(CFC) solvents.
Inspect the sterile package before opening.
If the seal or package is damaged, contact your local Medtronic
representative. The product should not be exposed to temperatures
70º C (158º F).
Parameter/Description
Polarity - Bipolar
Chamber - Atrium/ventricle
Fixation - Active, screw-in
Lengths
Lead - 100, 140, 200 cm
Guide Catheter - 40, 60, 90 cm
Diameters
Lead - 3.5 Fr. (1.1 mm, 0.044 in.)
Guide Catheter - 6 Fr. O.D., 5 Fr. I.D.
Helix
Design - Two right turns
Length - 0.8 mm (0.032 in.)
Diameter - 0.9 mm (0.035 in.)
Tip Electrode (included helix)
Surface Area - 4.3 mm squared
Ring Electrode
Surface Area - 17 mm squared
Tip Ring Spacing - 1 cm (0.39 in.)
Connector
Bifurcated, pull-through
short arm = positive
long arm = negative
Lead Material
Conductor - Stainless Steel
Insulation - Polyethylene and FEP
Helix - Stainless Steel
Catheter Material – Pebax
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