Medtronic 6701 Technical Manual

6701

Lead end cap

Technical Manual

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

The following list includes trademarks or registered trademarks of
Medtronic in the United States and possibly in other countries. All other
trademarks are the property of their respective owners.

Medtronic

Description/intended use

The 6701 Lead End Cap is a 6.5 mm (0.26 in) silicone
rubber cap designed to cover the connector pin of
implantable cardioversion/defibrillation lead systems
with connectors from 6.1 to 6.5 mm (0.24 to 0.26 in) in
diameter. It is used to insulate the connector pins of
leads that have been implanted but not connected to
an implantable arrhythmia management device (i.e.
prophylactic placement) or to seal off leads that are to
be abandoned. The cap is intended to prevent
current flow through the lead and to protect
surrounding tissue from being damaged by the
exposed connector pin.

Package contents

Dispose of all single-use accessories according to
local environmental requirements. Each package
contains the following items:

• Two (2) 6.5 mm (0.26 in) lead end caps

• Product documentation

Contraindications

To date, there are no known contraindications to the
use of the 6701 Lead End Cap.

Warnings and precautions

Note: Medical procedure warnings and precautions

that pertain to the Medtronic implanted system are
provided in the manual that is packaged with the
device or on the Medtronic Manual Library website
(www.Medtronic.com/manuals).

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Review the lead documentation – Since the lead
end cap is a functional extension of the lead, it is
recommended that the lead documentation be
reviewed for all appropriate warnings, complications,
precautions, and instructions.

Line-powered equipment – An implanted lead or
an implanted lead connected to a lead end cap forms
a direct low-resistance 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 or an implanted lead connected to a lead end
cap must be insulated from any leakage currents that
may arise from line-powered equipment.

External defibrillation equipment – Keep external
defibrillation equipment nearby for immediate use
during the implant procedure and whenever
arrhythmias are possible or intentionally induced.

Handling the lead end caps – Lead insulators
attract small particles such as lint and dust; therefore,
protect the lead end cap(s) from materials shedding
these substances.

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 use the product after its expiration date.

Sterilization – Medtronic has sterilized the package
contents with ethylene oxide before shipment. This

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device is for single use only and is not intended to be
resterilized.

Potential complications

The following are known potential complications
related to the use of a cardioversion/defibrillation
lead system, of which a lead end cap is a part:
infection, myocarditis, constrictive pericarditis,
fibrillation, hemothorax, and bleeding after
placement, after repositioning, or if sutures tear out.

Other known potential complications related to the
cardioversion/defibrillation lead system and the
programmed parameters of an implantable
arrhythmia management device include the
following:

Complication Possible effects

Displacement, lead insu­lator or conductor frac­ture, poor connection to
the device or lead

Intermittent or continu­ous loss of sensing and
pacing; intermittent or
continuous loss of defib­rillation or cardioversion
therapya; and possible
muscle stimulation in the
pocket area

Electrode fracture Intermittent or continu-

ous loss of pacing, sens­ing, defibrillation, or car­dioversion therapy

a

Threshold elevation Loss of pacing, sensing,

defibrillation, or cardio­version therapy

a

a

Loss of detection, defibrillation, cardioversion, or pacing
therapies may occur due to lead dislodgement, fracture, or
threshold elevation. Therefore, the patient’s ECG should be

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monitored during the hospital stay. If such loss occurs,
check pacing/ sensing thresholds or X-rays for lead
dislodgement or conductor fracture.

Instructions for use

To use the lead end cap, follow these steps:

1. Insert the lead terminal pin into the 6701 lead
end cap so that the three sealing rings on the
lead are fully covered and the terminal pin is
sealed in the tip. If a lubricant is needed, use
sterile water only.

Caution: Do not use medical adhesive to
secure the lead end cap; this could damage the
insulation or make the lead end cap impossible
to remove.

2. Place a nonabsorbable, synthetic ligature in the
single groove closest to the opening of the lead
end cap and tie it (see Figure 1).

3. The lead end cap can be removed at a later date
without damage to the lead.

Figure 1.

Caution: Do not place ligature in groove(s)

distal to lead end cap opening.

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General warning

Medtronic lead end caps are used with leads, which
are implanted in the extremely hostile environment of
the human body. Leads or lead end caps may fail to
function for a variety of causes, including, but not
limited to: medical complications, body rejection
phenomena, allergic reaction, fibrotic tissue, or
failure of leads by breakage or by breach of their
insulation covering. In addition, despite the exercise
of all due care in design, component selection,
manufacture, and testing prior to sale, leads or lead
end caps may be easily damaged before, during, or
after insertion by improper handling or other
intervening acts. Consequently, for leads used with
lead end caps, no representation or warranty is made
that failure or cessation of function will not occur or
that the body will not react adversely to the
implantation of leads or that medical complications
(including perforation of the heart) will not follow.

Medtronic disclaimer of warranty

For complete disclaimer of warranty information, see
the accompanying disclaimer of warranty document.

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.

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CE mark of conformity

The following CE mark of conformity applies to the
Model 6701 lead end cap.

1994

Explanation of symbols

Table 1. Explanation of symbols on package

labeling
Refer to the package labels to see which symbols

apply to this product.

Conformité Européenne (European
Conformity). This symbol means
that the device fully complies with
applicable European Union acts.

For U.S. audiences only

Authorized representative in the
European community

Date of manufacture

Manufacturer

Use by

Lot number

Reorder number

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

Serial number

Sterilized using ethylene oxide

Do not reuse

Do not use if package is damaged

Upper limit of temperature

Open here

Consult instructions for use at this
website

Package contents

Product documentation

6.5 mm lead end cap

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Medtronic, Inc.

*M971375A001*

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

Authorized Representative
in the European Community

Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
[phone]

Europe/Middle East/Africa

Medtronic International
Trading Sàrl
Route du Molliau 31
Case Postale 84
CH-1131 Tolochenaz
Switzerland
[phone]

Australia

Medtronic Australasia Pty Ltd
5 Alma Road
Macquarie Park, NSW 2113
Australia
1800 668 670

Canada

Medtronic of Canada Ltd
99 Hereford Street
Brampton, Ontario L6Y 0R3
Canada
[phone]

Technical manuals

www.medtronic.com/manuals

© 2017 Medtronic
M971375A001 A
2017-07-27