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SELECTSECURE® 3830
Steroid eluting, bipolar, implantable, nonretractable screw-in, atrial/ventricular, catheter delivered,
transvenous lead
Technical Manual
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
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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, SelectSecure
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Contents
1 Description 3
2 Drug component description 3
3 Indications for use 4
4 Contraindications 4
5 Warnings and precautions 4
6 Drug information 5
7 Potential complications 6
8 Clinical trial 6
9 Directions for use 11
10 Specifications (nominal) 16
11 Medtronic warranty 17
12 Service 17
1.1 Package contents
The lead and accessories are supplied sterile. Each package
contains the following items:
●
1 lead with anchoring sleeve
●
1 vein lifter
●
Product documentation
1.2 Accessory descriptions
Dispose of all single-use accessories according to local
environmental requirements.
Anchoring sleeve – An anchoring sleeve secures the lead from
moving and protects the lead insulation and conductors from
damage caused by tight sutures.
Vein lifter – A vein lifter facilitates catheter or introducer insertion
into a vessel.
1 Description
The Medtronic SelectSecure Model 3830 steroid eluting, bipolar,
implantable, nonretractable screw-in, atrial/ventricular, catheter
delivered, transvenous lead is designed for pacing and sensing
in the atrium or ventricle.
The lead has a nonretractable helical electrode made of titanium
nitride coated platinum alloy for active fixation in the endocardium
by rotating the lead body in a clockwise direction. Active fixation
leads are particularly beneficial for patients who have smooth or
hypertrophic hearts where lead dislodgement may be a potential
problem.
The lead also has a second, larger electrode made of titanium
nitride coated platinum alloy proximal to the tip electrode and an
IS-11 Bipolar (BI) connector. The lead features MP35N nickel
alloy conductors, silicone inner insulation, and polyurethane outer
insulation.
The distal tip contains a target dose of 17.2 µg of beclomethasone
dipropionate. Upon exposure to body fluids, the steroid elutes
from the lead tip. Steroid is known to suppress the inflammatory
response that is believed to cause threshold rises typically
associated with implanted pacing electrodes.
Note: To implant the Model 3830, a compatible delivery system
is required, such as a Medtronic delivery system. A compatible
delivery system includes a guide catheter and an introducer valve
which allows passage through or removal from an IS-1 connector.
Contact your local Medtronic representative for further
information regarding compatible delivery systems.
2 Drug component description
The active ingredient in the Model 3830 lead is beclomethasone
17,21-dipropionate. The chemical name of beclomethasone
dipropionate is 9-chloro-11β,
17,21-trihydroxy-16β-methylpregna-1,4-diene-3, 20 dione
17,21-dipropionate. The structural formula for beclomethasone
17,21-dipropionate is shown below:
Figure 1. Structural formula for beclomethasone 17,21-dipropionate
Beclomethasone 17,21-dipropionate is a diester of
beclomethasone, a synthetic halogenated corticosteroid.
Beclomethasone 17,21-dipropionate is a white to creamy white,
odorless powder with a molecular formula of C28H37CIO7 and a
molecular weight of 521.05. It is very slightly soluble in water, very
soluble in chloroform, and freely soluble in acetone and alcohol.
The nominal dosage of bethomethasone 17,21-dipropionate per
Model 3830 lead is 17.2 µg
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.
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3 Indications for use
The Model 3830 lead has application where implantable atrial or
ventricular, single-chamber or dual-chamber pacing systems are
indicated. The Model 3830 lead is intended for pacing and
sensing in the atrium or ventricle.
4 Contraindications
The following are contraindications for use of Medtronic
implantable, screw-in, catheter delivered, transvenous leads.
●
Use of ventricular transvenous leads is contraindicated in
patients with tricuspid valvular disease.
●
Use of ventricular transvenous leads is contraindicated in
patients with mechanical tricuspid heart valves.
●
Use of steroid eluting transvenous leads is contraindicated in
patients for whom a single dose of 40.0 µg beclomethasone
dipropionate may be contraindicated.
●
Use of catheter-delivered transvenous leads is
contraindicated in patients with obstructed or inadequate
vasculature for intravenous catheterization.
5 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).
Inspecting the sterile package – Inspect the sterile package
with care before opening.
●
Contact your local Medtronic representative if the seal or
package is damaged.
●
Store at 25 °C (77 °F). Excursions from this storage
temperature are permitted in the range of 15 to 30 °C (59 to
86 °F). (See USP Controlled Room Temperature.) According
to USP excursion conditions, transient spikes up to 40 °C
(104 °F) are permitted as long as they do not exceed 24 hours.
●
Do not use the product after its expiration date.
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.
Single use – The lead and accessories are for single use only.
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.
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.
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.
Handling the steroid tip – Avoid reducing the amount of steroid
available prior to lead implantation. 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 the lead – Handle the lead with care at all times.
●
Do not implant the lead if it is damaged. Return the lead to
your Medtronic representative.
●
Do not attempt to straighten or realign the helix if the helix is
deformed. Return the lead to your 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 apply pressure to the helix.
●
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. Resistance can be a result of guide catheter
occlusion, i.e. kinking, folding, or thrombosis, or that the lead
is in contact with cardiac tissue.
●
Keep the helix within the guide catheter of the delivery system
if passing through the tricuspid valve to prevent damage to
the helix, valve, and/or endocardial tissue.
Vessel and tissue damage – Use care when positioning the
lead.
●
Consider another site for lead placement other than the apex
of the right ventricle if there is reason to believe the patient
has an unusually thin wall at the apex of the right ventricle.
●
Avoid known infarcted or thin ventricular wall areas to
minimize the occurrence of perforation and dissection.
●
Avoid acute trauma to the endocardium, including possible
perforation, caused by excessive torque and/or tip pressure.
Acute trauma to the endocardium may result in temporarily
high impedance or threshold values.
Chronic repositioning or removal – Proceed with extreme
caution if a lead must be removed or repositioned. Chronic
repositioning or removal of screw-in transvenous leads may not
be possible because the helix may become deformed and/or
entangled as a result of manipulating the lead. In most clinical
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situations, it is preferable to abandon unused leads in place.
Return all removed or unused leads, or lead sections to Medtronic
for analysis.
●
Observe the helix via fluoroscopy or x-ray before attempting
to reposition to determine if the helix shape is intact. If the helix
appears deformed, removal may be difficult and is not
recommended.
●
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.
●
Abandoned leads should be capped to avoid transmitting
electrical signals.
●
Severed leads should have the remaining lead end sealed
and the lead body sutured to adjacent tissue.
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.
Diathermy treatment (including therapeutic ultrasound) –
Diathermy is a treatment that involves the therapeutic heating of
body tissues. Diathermy treatments include high frequency, short
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 leads.
Therapeutic 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 leads.
Drug interactions – No drug interactions with inhaled
beclomethasone 17,21–dipropionate have been described. Drug
interactions of beclomethasone 17,21–diipropionate with the
Model 3830 lead have not been studied.
Use of multiple leads – Prior to implanting the Model 3830 lead,
total patient exposure to beclomethasone 17,21–dipropionate
should be considered when implanting multiple leads.
Acute repositioning or removal of the lead – Successfully
repositioning the lead depends on recreating the angle and
advancement of the catheter present at the time of initial helix
deployment at implant (relative to the lead helix and
endocardium). Proper orientation helps transfer torque to the
helix. This increases the likelihood of successfully disengaging
the helix from the endocardium. Improper removal of the lead by
pulling may result in avulsion of the endocardium.
6 Drug information
6.1 Mechanism of action
Steroids suppress the inflammatory response that is believed to
cause threshold rises typically associated with implanted pacing
electrodes. Beclomethasone dipropionate (BDP) is a synthetic
steroid of the glucocorticoid family. Glucocorticoid steroids have
potent anti-inflammatory actions via direct and indirect effects on
major inflammatory cells. While the mechanism of action of
glucocorticoids is not fully understood, it is known that
glucocorticosteroids bind to a cytoplasmic glucocorticoid
receptor as well as to a membrane-bound receptor. Binding to the
cytoplasmic receptor leads to receptor activation and
translocation to the nucleus. The receptor interacts with specific
DNA sequences (glucocorticoid responsive elements) within the
regulatory regions of affected genes. Thus, glucocorticoids inhibit
the production, by multiple cells, of factors that are critical in
generating the inflammatory response, in particular via
modulation of transcription factors.
6.2 Pharmacokinetics and metabolism
Pharmacokinetics – The pharmacokinetics (local drug levels
and systemic levels) of beclomethasone dipropionate and its
metabolites following implant of the Model 3830 leads were not
evaluated in human clinical trials. A preclinical animal study using
multiple leads and as assay with a limit of quantitation of 80 pcg/ml
did not show any detectable levels of BDP, however, this study
did not determine the levels of active metabolite,
beclomethasone-17-monopropionate.
Metabolism – Beclomethasone dipropionate (BDP) is a prodrug
with weak glucocorticoid receptor binding affinity that is
hydrolyzed via esterase enzymes to the active metabolite
beclomethasone-17-monopropionate (17-BMP). Minor inactive
metabolites, beclomethasone-21-monopropionate (21-BMP)
and beclomethasone (BOH), are also formed. The mean
elimination half-life of 170-BMP is 2.8 hours. Irrespective of the
route of administration (injection, oral, or inhalation), BDP and its
metabolites are mainly excreted in the feces. Less than 10% of
the drug and its metabolites are excreted in the urine.
6.3 Mutagenesis, carcinogenicity, and reproductive toxicity
The mutagenesis, carcinogenicity, and reproductive toxicity of
the Model 3830 lead have not been evaluated. However, the
mutagenesis, carcinogenicity, and reproductive toxicity of
beclomethasone dipropionate have previously been evaluated.
Mutagenesis – Beclomethasone dipropionate did not induce
gene mutation in bacterial cells or mammalian Chinese Hamster
ovary (CHO) cells in vitro or in the mouse micronucleus test in
vivo.
Carcinogenicity – BDP was administered to rats for a total of
95 weeks (13 weeks inhalation: up to 0.4 mg / kg daily, 82 weeks
oral administration: up to 2.4 mg / kg daily). Both of which
represent approximately 40 times the maximum recommended
human intranasal dosage on a mg / m2 basis. There was no
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evidence of carcinogenic activity2. It is known that glucocorticoids
are potent inhibitors of carcinogenesis3. Specifically, in a mouse
model of benzypyrene-induced pulmonary adenoma formation,
BDP inhalation reduced carcinoma formation by up to 60%3.
Reproductive toxicity – Although there are no adequate and
controlled studies that have been conducted to date in humans,
subcutaneously administered BDP, at dosages that are
approximately 1.2 times the maximum human intranasal dosage
(on a mg / m2 basis), have been shown to be teratogenic and
embryocidal in rats and rabbits receiving 0.1 mg / kg and
0.025 mg / kg daily, respectively. Teratogenic effects in these
animals include fetal resorption, cleft palate, agnathia,
microstomia, aglossia, delayed ossification, and agenesis of the
thymus gland. Teratogenic or embryocidal effects were not
observed in rats following a combination of oral administration
and inhalation of BDP at dosages of 10 and 0.1 mg / kg daily,
respectively (approximately 250 times the maximum
recommended human intranasal dosage [on a mg / m2 basis]2).
6.4 Pregnancy
Pregnancy category C – Like other corticosteroids,
beclomethasone dipropionate was teratogenic and embryocidal
in the mouse and rabbit at a subcutaneous dose of 0.1 mg / kg in
mice or 0.025 mg / kg in rabbits. There are no adequate and
well-controlled studies in pregnant women of beclomethasone
dipropionate or the Model 3830 lead. The Model 3830 lead should
be used during pregnancy only if the potential benefit outweighs
the potential risk to the fetus.
6.5 Lactation
Corticosteroids are secreted into human milk and there is a
potential for serious adverse reactions. A decision should be
made whether to nurse or to discontinue the drug, taking into
account the importance of the drug to the mother. These potential
risks of corticosteroids should also be considered along with any
other steroidal therapy being received by the patient.
●
Thrombotic and air embolism
●
Thrombosis
●
Valve damage (particularly in fragile hearts)
Other potential complications related to the lead and the
programmed parameters include, but are not limited to, the
complications listed in the following table. Symptoms of the
following complications include loss of capture or intermittent or
continuous loss of capture or sensing4:
Complication
Lead dislodgement Reposition the lead
Lead conductor or helix electrode
fracture or insulation failure
Threshold elevation or exit block Adjust the implantable device out-
Corrective action to be considered
Replace the lead. In some cases
with a bipolar lead, the implantable
device may be programmed to a
unipolar configuration or the lead
may be unipolarized.
put. Replace or reposition the lead
Potential acute/chronic complications associated with lead
placement that may require lead replacement to correct include,
but are not limited to, the following:
Implant technique Potential complication
Forcing the lead through the guide
catheter
Use of too medial an approach
with the guide catheter resulting in
clavicle & first rib binding
Puncturing the periosteum and/or
tendon when using subclavian
guide catheter approach
Helix electrode damage and/or
insulation damage
Conductor coil fracture, insulation
damage
Conductor coil fracture, insulation
damage
7 Potential complications
The potential complications 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 and/or
repositioned.
●
Cardiac perforation
●
Cardiac tamponade
●
Fibrillation and other arrhythmias
●
Heart wall or vein wall rupture
●
Infection
●
Muscle or nerve stimulation
●
Pericardial rub
●
Pneumothorax
2
AHFS Drug Information, 1999, ISBN 1-879907-91-7, pp 2420.
3
Wattenberg, LW, et al., Chemoprevention of pulmonary carcinogenesis by brief exposures to aerosolized budesonide or beclomethasone dipropionate and by the
combination of aerosolized budesonide and dietary myo-inositol. Carcinogenesis 2000; 21 (2): 179-182.
4
Transient loss of capture or sensing may occur for a short time following surgery until lead stabilization takes place. If stabilization does not occur, lead dislodgement
may be suspected.
8 Clinical trial
The following section describes the safety and effectiveness
clinical trial of the Medtronic Model 3830 lead.
8.1 Summary
A multi-center, prospective, non-randomized control clinical
study conducted at 26 investigational sites in the United States,
4 investigational sites in Canada, and 1 investigational site in
Australia compared the Model 3830 steroid eluting lead using the
Model 5076 steroid eluting lead as a historical control. The Model
3830 and Model 5076 leads are both active fixation leads.
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Data was collected for a total of 271 patients enrolled in the study.
Model 3830 Patients Enrolled N = 271
Implant Not Attempted N = 7
Implant Attempted
N = 264
Patient Did Not Meet
Inclusion Criteria N = 1
Roll-in Patients N = 86
Non-Roll-in Patients N = 177
Successful
N = 82
Successful
N = 169
Unsuccessful1 N=4
Unsuccessful2
N=84
3M Follow-Ups N=81
3M Follow-Ups N=164
Model 5076 Patients Enrolled N = 228
Implant Not Attempted N = 0
Implant Attempted
N = 228
Roll-in Patients N = 101
Non-Roll-in Patients N = 127
Successful
N = 98
Successful
N = 121
Unsuccessful1 N=3
Unsuccessful2
N=6
3M Follow-Ups N=92
3M Follow-Ups N=112
Of these patients, 264 patients underwent lead implant attempts
(86 roll-in patients and 178 non-roll-in patients). One non-roll-in
patient did not meet the inclusion/exclusion criteria and is not
included in any of the data summaries. Follow-up was performed
at pre-discharge (within 48 hours post-implant), 2 weeks, 1
month, and 3 months to meet study objectives. Patients continue
to be followed at 6 months and every 6 months thereafter until
study closure. See Figure 2 and Figure 3 for enrollment and
follow-up of the Model 3830 lead and the Model 5076 lead.
Figure 2. Model 3830 enrollment and follow-up
1 Four patients with unsuccessful implants in the roll-in group did not
receive a Model 3830 lead in either chamber and did not continue to
be followed past implant.
2 Five of eight patients had at least one Model 3830 lead implanted
and continued to be followed per the protocol.
Figure 3. Model 5076 enrollment and follow-up
1 Three of three patients with unsuccessful implants in the roll-in group
had a least one Model 5076 lead implanted and continued to be
followed per the protocol.
2 Five of six patients had at least one Model 5076 lead implanted and
continued to be followed per the protocol.
Each implanting physician was required to enroll 2 roll-in patients
that were followed for adverse events, but were not included in
the analysis of the primary objectives.
8.2 Primary objectives
The following are the primary objectives of the Model 3830clinical
trial:
●
Demonstrate the safety of the Model 3830 by comparing
lead-related complications to those seen in the Model 5076.
●
Demonstrate the safety of the Model 3830 by comparing lead
related events to those seen in the Model 5076.
●
Demonstrate the effectiveness of the Model 3830 by
comparing pacing performance to the Model 5076.
●
Demonstrate the effectiveness of the Model 3830 by
comparing sensing performance to the Model 5076.
8.3 Clinical trial results
8.3.1 Primary objective: lead related adverse events
176 patient implant attempts with a Model 3830 lead in the atrium
were analyzed per the statistical plan. There were a total of 15
atrial lead-related adverse events occurring in 14 patients. Of
these 15 events, 5 are complications (2 of these complications
were reported after the 3-month follow-up visit) and 10 are
observations. See Table 1 for the types of atrial lead-related
adverse events reported.
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177 patient implant attempts with a Model 3830 lead in the
ventricle were analyzed per the statistical plan. There were a total
of 30 ventricular lead-related adverse events occurring in 28
patients. Of these 30 events, 12 (occurring in 12 patients) are
complications and 18 are observations. See Table 2 for the types
of ventricular lead-related adverse events reported.
Table 1. Atrial lead-related events
Complica-
Event
Elevated pacing thresholds
Lead dislodgment 2/2 1/1 3/3
Muscle stimulation 0/0 2/1 2/1
Failure to sense/undersensing
Venous occlusion 0/0 1/1 1/1
AFib/flutter 0/0 1/1 1/1
Pocket infection 1/1 0/0 1/1
Total 5/5 10/9 15/14
a
A complication is defined as an event that is resolved invasively or that
directly results in the death of, or serious injury to, the patient; the explant
of the device; or the termination of significant device function regardless
of other treatments. IV and IM drug therapies are considered invasive
treatment.
b
An observation is defined as an event that is resolved by non-invasive
means such as medically or by reprogramming the device, or that is
resolved spontaneously. Oral drugs are considered non-invasive
treatment.
c
Not mutually exclusive.
tionsa/Pati
ents
0/0 4/4 4/4
2/2 1/1 3/3
Observa-
tionsb/Pati
c
ents
Total
Events/Pat
c
ients
The atrial lead-related adverse event rate for the Model 3830 was
found to be clinically equivalent to the Model 5076 at 3 months.
The 95% upper confidence bound on the difference between
rates of survival was 6.48%, which is less than the 10% bound
criteria.
Table 2. Ventricular lead-related events
Complica-
Event
Elevated pacing thresholds
Lead dislodgment 3/3 0/0 3/3
Failure to capture/loss of
capture
Muscle stimulation 0/0 2/2 2/2
Pericardial effusion 3/3 1/1 4/4
Venous occlusion 0/0 1/1 1/1
Cardiac perforation 0/0 1/1 1/1
Cardiac tamponade 1/1 0/0 1/1
Pocket infection 1/1 0/0 1/1
tionsa/Pati
ents
2/2 12/12 14/14
1/1 1/1 2/2
c
Observa-
tionsb/Pati
ents
Total
Events/Pat
c
ients
Table 2. Ventricular lead-related events (continued)
Complica-
Event
Chest pain/angina pectoris
Total 12/12 18/17 30/28
a
A complication is defined as an event that is resolved invasively or that
directly results in the death of, or serious injury to, the patient; the explant
of the device; or the termination of significant device function regardless
of other treatments. IV and IM drug therapies are considered invasive
treatment.
b
An observation is defined as an event that is resolved by non-invasive
means such as medically or by reprogramming the device, or that is
resolved spontaneously. Oral drugs are considered non-invasive
treatment.
c
Not mutually exclusive.
tionsa/Pati
ents
1/1 0/0 1/1
c
Observa-
tionsb/Pati
ents
Total
Events/Pat
c
ients
The ventricular lead-related adverse event rate for the Model
3830 was found to be clinically equivalent to the lead Model 5076
at 3 months. The 95% upper confidence bound on the difference
between rates of survival was 8.99%, which is less than the 10%
bound criteria.
8.3.2 Primary objective: lead related complications
The ventricular lead-related complication rate for the Model 3830
was not found to be clinically equivalent to the Model 5076 at 3
months. The 95% upper confidence bound on the difference
between rates of survival was 7.10%, which is greater than the
6% bound criteria.
The atrial lead-related complication rate for the Model 3830 was
found to be clinically equivalent to the Model 5076 at 3 months.
The 95% upper confidence bound on the difference between
rates of survival was 2.62%, which is less than the 6% bound
criteria.
The ventricular lead related complication rate was continually
evaluated during the clinical study. After the start of the implant
phase, the sponsor held a meeting with the investigators to review
the study adverse events and make implant technique
recommendations. Prior to these recommendations, four
ventricular lead related complications had occurred in the first 37
non-roll-in system implants (10.8% rate). After providing
additional instruction on implant technique, an additional 140
patients were enrolled in the non-roll-in population, of which 6
additional ventricular lead related complications occurred (4.3%
rate). The recommended techniques are summarized inTable 3 :
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Table 3. Recommended methods for minimizing Model 3830
.025
.050
.075
.100
.125
.150
.175
.200
.225
.250
114
160
100
154
95
143
60
126
62
3M 6M 12M 18M
Visit
PHD
ms
.025
.050
.075
.100
.125
.150
.175
.200
.225
.250
3M 6M 12M 18M
119
168
105
160
99
153
65
138
65
Visit
PHD
ms
lead implant difficulties.
Potential difficulties Recommendation
Catheter kinks, folds, or creases during lead implant, resulting in
Extend lead to distal tip of cath-
eter prior to deflecting catheter.
increased lead resistance during
deployment.
Cardiac perforation from catheter
during catheter positioning.
Cardiac perforation from catheter
during lead positioning
Track catheter over a guide wire
to implant location.
When distal tip of guide catheter
is near desired location for lead
placement, gently advance the
lead through the guide catheter
until the helix extends beyond
the distal opening of the guide
catheter. Avoid extending cath-
eter up against wall.
Cardiac perforation during lead fixation
Avoid over-rotation of the lead;
recommend 3-4 turns to affix the
ventricular helix; 4-5 turns to
affix the atrial helix.
Excessive force on lead during the
slitting process results in lead dislodgment
Confirm helix fixation, gently
advance lead and retract cathe-
ter to provide adequate lead
slack. Slit off catheter, then
establish final amount of slack
on lead.
There were 4 catheter related adverse events which describe
kinking of the catheter that occurred during the Model 3830
clinical study. These 4 events resulted in unsuccessful final lead
placement of the Model 3830 investigational lead in 4 patients. All
events were categorized as catheter-related observations
involving 2 roll-in and 2 non-roll-in patients. All events were
resolved on the date of occurrence.
8.3.3 Primary objective: pacing performance
The atrial pulse width threshold for the Model 3830 was found to
be clinically equivalent to the lead Model 5076 through the
3-month follow-up (patients unable to capture at 2.5 V were not
included in the analysis). The 95% upper confidence bound on
the difference was 0.026 ms, which is less than the 0.06 ms bound
criteria. See Figure 4 for a comparison of Model 3830 and Model
5076 atrial pulse width thresholds.
5
Means with 95% Confidence Intervals; Values listed are the number of patients at each time point
Figure 4. Atrial pulse width thresholds
5
The ventricular pulse width threshold for the Model 3830 was
found to be clinically equivalent to the lead Model 5076 through
the 3-month follow-up (patients unable to capture at 2.5 V were
not included in the analysis). The 95% upper confidence bound
on the difference was 0.015 ms, which is less than the 0.06 ms
bound criteria. See Figure 5 for a comparison of Model 3830 and
Model 5076 ventricular pulse width thresholds.
Figure 5. Ventricular pulse width thresholds
5
8.3.4 Primary objective: sensing data
The P-wave amplitude for the Model 3830 was found to be
clinically equivalent to the lead Model 5076 through the 3-month
follow-up. The 95% upper confidence bound on the difference
was 1.204 mV, which is less than the 1.5 mV bound criteria. See
Figure 6 for a comparison of Model 3830 and Model 5076 P-wave
sensing amplitudes.
9
Page 10
Figure 6. Atrial sensing
2.0
2.5
3.5
4.5
3M 6M 12M 18M
110
157
101
148
96
141
60
127
61
Visit
PHD
mV
8
9
10
11
12
13
14
3M 6M 12M 18M
96
155
95
152
86
139
54
125
55
Visit
PHD
mV
5
The clinical study proves that the Model 3830 lead, the first lead
without a stylet lumen, and first right-sided pacing lead delivered
by a steerable catheter sheath:
●
Achieved primary electrical endpoints as compared to the
Model 5076 standard stylet lead through three months.
●
Had an atrial and ventricular lead complication rate
comparable to other currently marketed Medtronic leads
(Models 5068 and 4068).8 (See Table 4). The atrial lead
related complication rate achieved the primary safety end
point compared to the 5076. The overall ventricular lead
related complication rate exceeded the Model 5076 lead.
Interim review of the data and modified implant technique
recommendations were implemented with a corresponding
decrease in ventricular lead related complications in
alignment with current Medtronic marketed leads.
●
Was implanted without an increase in lead related adverse
events compared to currently marketed Medtronic
The R-wave amplitude for the Model 3830 was found to be
clinically equivalent to the lead Model 5076 through the 3-month
follow-up. The 95% upper confidence bound on the difference
was 1.578 mV, which is less than the 3.0 mV bound criteria. See
Figure 7 for a comparison of Model 3830 and Model 5076 R-wave
sensing amplitudes.
Figure 7. Ventricular sensing
5
8.4 Conclusions
The Medtronic Model 3830 lead was engineered and designed
stylet-delivered active fixation leads (see Table 4).
●
At implant and follow-up had no unanticipated adverse device
effects (UADE).
●
Had a total lead related adverse event rate that is comparable
to current published event rates of other Medtronic marketed
10
leads.9,
Table 4. Adverse event comparison through 3 months
Lead N
Model 3830
(Includes
roll-in pts)
Model 5076
(Includes
roll-in pts)
262 atrial
263 ventric-
ular
229 atrial
228 ventric-
ular
Model 4068c297 atrial
372 ventric-
events
12 (in 12
pts) 12/262
= 4.6%
8 (in 8 pts)
8/229 =
3.5%
32/297 =
10.8%
ular
Atrial
Model 5068c122 atrial
122 ventric-
ular
a
3 months is defined as 135 days for all studies.
b
In the 3830 study, one event (in one patient) was classified as both atrial
and ventricular lead related.
c
Information provided for comparison purposes only. This lead was not
6 (in 6 pts)
6/122 =
4.9%
included in the Model 3830 clinical study.
Ventricu-
lar events
27 (in 26
pts) 27/263
= 10.3%
15 (in 15
pts) 15/228
= 6.6%
31/372=
8.3%
13 (in 13
pts) 13/122
= 10.7%
to meet implanting physician’s requirements for improvements
over current pacing lead therapy. New data indicates an evolving
clinical need to implant increased numbers of leads6, 7and
improve on long term pacing lead reliability.
6
Saksena S. The Role of Multisite Atrial Pacing in Rhythm Control in AF: Insights from Sub-analyses of the Dual Site Atrial Pacing for Prevention of Atrial Fibrillation
Study. Pacing Clin Electrophysiol. 2003 Jul;26(7 Pt 1):1565.
7
Saksena S. The Role of Multisite Atrial Pacing in Rhythm Control in AF: Insights from Sub-analyses of the Dual Site Atrial Pacing for Prevention of Atrial Fibrillation
Study. Pacing Clin Electrophysiol. 2003 Jul;26(7 Pt 1):1565.
8
Information provided for comparison purposes only. These leads were not included in the Model 3830 clinical study.
9
Hill PE Complications of permanent transvenous cardiac pacing: a 14-year review of all transvenous pacemakers inserted at one community hospital. PACE 1987
May;(Pt 1):564-70.
10
Crossley GH, Tonder L. et al. Active Fixation Permanent Pacemaker Leads Have More Perforations than Passive Fixation Leads and a Similar dislodgment Rate.
Circ 94:I-677 Oct 15, 1996.
10
a
Total
events
38 (in 36
pts) 38/525
b
= 7.2%
23 (in 23
pts)
23/457=
5.0%
63/669 =
9.4%
19 (in 16
pts) 19/244
= 7.8%
Page 11
No unanticipated adverse device effects were reported in this
study and the lead performed effectively through three months
with respect to lead-related adverse events, pacing performance,
and sensing performance. Although the primary objective for
ventricular lead-related complications was not met, the types of
complications and the rate at which ventricular lead related
complications occurred are comparable to other commercially
available leads as reported in the literature.
9 Directions for use
Note: To implant the Model 3830, a compatible delivery system
is required, such as a Medtronic delivery system. A compatible
delivery system includes a guide catheter and an introducer valve
which allows passage through or removal from an IS-1 connector.
Contact your local Medtronic representative for further
information regarding compatible delivery systems.
Proper surgical procedures and sterile techniques are the
responsibility of the medical professional. Some implantation
techniques vary according to physician preference and the
patient’s anatomy or physical condition. The implantation
procedure generally includes the following steps:
●
Preparing the delivery system
●
Selecting an insertion site
●
Inserting the guide catheter assembly
●
Positioning the guide catheter
●
Inserting the lead into the guide catheter
●
Positioning the lead
●
Verifying helix electrode fixation
●
Taking electrical measurements
●
Acute repositioning or removal of the lead
●
Removing the guide catheter from the lead
●
Anchoring the lead
●
Connecting the lead
●
Placing the implantable device and lead(s) into the pocket
9.1 Recommended methods for minimizing lead implant difficulties
The potential difficulties associated with the lead implant can be
minimized using the following recommendations:
Table 5. Recommended methods for minimizing Model 3830 lead implant difficulties.
Potential difficulties Recommendation
Catheter kinks, folds, or creases during lead implant, resulting in
increased lead resistance during
deployment.
Cardiac perforation from catheter
during catheter positioning.
Extend lead to distal tip of cath-
eter prior to deflecting catheter.
Track catheter over a guide wire
to implant location.
Table 5. Recommended methods for minimizing Model 3830
lead implant difficulties. (continued)
Potential difficulties Recommendation
Cardiac perforation from catheter
during lead positioning
Cardiac perforation during lead fixation
Excessive force on lead during the
slitting process results in lead dislodgment
When distal tip of guide catheter
is near desired location for lead
placement, gently advance the
lead through the guide catheter
until the helix extends beyond
the distal opening of the guide
catheter. Avoid extending catheter up against wall.
Avoid over-rotation of the lead;
recommend 3-4 turns to affix the
ventricular helix; 4-5 turns to
affix the atrial helix.
Confirm helix fixation, gently
advance lead and retract catheter to provide adequate lead
slack. Slit off catheter, then
establish final amount of slack
on lead.
In the Model 3830 clinical study, the ventricular lead-related
complication rate for the Model 3830 was not found to be clinically
equivalent to the Model 5076 at 3 months. The 95% upper
confidence bound on the difference between rates of survival was
7.10%, which is grater than the 6% bound criteria.
The atrial lead-related complication rate for the Model 3830 was
found to be clinically equivalent to the Model 5076 at 3 months.
The 95% upper confidence bound on the difference between
rates of survival was 2.62%, which is less than the 6% bound
criteria.
The ventricular lead related complication rate was continually
evaluated during the clinical study. After the start of the implant
phase, the sponsor held a meeting with the investigators to review
the study adverse events and make implant technique
recommendations. Prior to these recommendations, 4 ventricular
lead related complications had occurred in the first 37 non-roll-in
system implants (10.8% rate). After providing additional
instructions on implant technique, an additional 140 patients were
enrolled in the non-roll-in population, of which 6 additional
ventricular lead related complications occurred (4.3% rate).
There were 4 catheter related adverse events which describe
kinking of the catheter that occurred during the Model 3830
clinical study. These 4 events resulted in unsuccessful final lead
placement of the Model 3830 investigational lead in 4 patients. All
events were categorized as catheter-related observations
involving 2 roll-in and 2 non-roll-in patients. All events were
resolved on the date of occurrence.
9.2 Preparing the delivery system
Prepare the delivery system for lead implantation according to the
instructions in the product literature packaged with the delivery
system.
11
Page 12
9.3 Selecting an insertion site
Caution: When using a subclavian approach for insertion, use a
more lateral approach to minimize the risk of first rib clavicular
crush. First rib clavicular crush may subsequently fracture the
lead body.
Caution: Certain anatomical abnormalities, such as thoracic
outlet syndrome, may pinch and subsequently fracture the lead
body.
The guide catheter assembly may be inserted through several
different venous routes, including the right or left cephalic vein or
other subclavian branches.
Select an insertion site. (See Figure 8 for suggested insertion site.
Figure 8.
1 Suggested entry site
9.4 Inserting the guide catheter assembly
The guide catheter assembly may be inserted using either the
vein lifter in the lead package or the method described in the
delivery system product literature.
The guide catheter assembly may be inserted using venotomy
through several venous routes, including the right or left cephalic
vein or other subclavian branches. It is recommended to use a
guide wire when inserting a guide catheter assembly. Advance
the guide catheter over the guide wire to facilitate positioning of
the guide catheter and to minimize the risk of tissue damage.
Insert the guide catheter assembly using the vein lifter:
Insert the guide catheter assembly using the vein lifter:
1. Insert the tapered end of the vein lifter into the incised vein
(Figure 9).
Figure 9.
2. Gently push the tip of the guide catheter assembly
underneath the vein lifter and into the vein.
See the delivery system product literature for the recommended
method of inserting the guide catheter assembly.
9.5 Positioning the guide catheter
See the delivery system product literature for details about
positioning the guide catheter in the right atrium or right ventricle.
9.6 Inserting the lead into the guide catheter
Warning: For leads that will be placed in the right ventricle, keep
the helix within the guide catheter when passing through the
tricuspid valve to prevent damage to the helix, valve, and/or
endocardial tissue.
Caution: If wiping the lead is necessary prior to insertion, avoid
snagging the helix in gauze and ensure that the anchoring sleeve
remains in position.
Insert the lead into the guide catheter. Pass the lead through the
introducer valve to minimize the backflow of blood.
Note: Keep the helix within the catheter’s distal tip.
9.7 Positioning the lead in the ventricle
Warning: To minimize the occurrence of perforation and
dissection, avoid known infarcted or thin ventricular wall areas.
Warning: If there is reason to believe the patient has an unusually
thin wall at the apex of the right ventricle, the implanter may wish
to consider another site for placement of the lead.
Warning: Excessive torque and/or tip pressure may cause acute
trauma to the endocardium, including possible perforation. The
acute trauma may result in temporary high impedance or
threshold values.
Position the lead in the ventricle:
1. Position the tip of the guide catheter in the ventricle. See the
delivery system product literature for details about
positioning the guide catheter in the ventricle.
12
Page 13
2. When the distal tip of the guide catheter is near the desired
location for lead placement, gently advance the lead while
retracting the guide catheter until the anode ring is extended
approximately 2-3 cm beyond the distal opening of the guide
catheter.
3. Use fluoroscopy to facilitate accurate lead placement.
4. Place one hand on the lead, by the valve, for stability; and,
place the other hand on the lead connector sleeve
(Figure 10). Using the hand on the lead connector sleeve,
rotate the lead body clockwise to affix the helix in the
endocardium. It is recommended that the implanter turn the
lead body approximately 3 to 4 complete (360°) rotations so
that the helix is fully imbedded in the endocardium.
Note: Use either the lead serial number label or the
anchoring sleeve to visually count the number of turns while
using fluoroscopy.
A possible indicator of helix fixation is when
counterclockwise rotation of the lead body is observed when
the hand on the connector sleeve is removed.
Accurate positioning of the electrode is essential for stable pacing
and sensing. A satisfactory position is usually achieved when the
above procedures are followed.
9.8 Positioning the lead in the atrium
Warning: Excessive torque and/or tip pressure may cause acute
trauma to the endocardium, including possible perforation. The
acute trauma may result in temporarily high impedance or
threshold values.
Warning: If there is reason to believe the patient has an unusually
thin wall at the appendage or lateral free wall of the right atrium,
the implanter may wish to consider another site for placement of
the lead.
Position the lead in the atrium:
1. Position the distal tip of the guide catheter in the atrium. See
the delivery system product literature for details about
positioning the guide catheter in the atrium.
2. When the distal tip of the guide catheter is near the desired
location for lead placement, gently push the lead through the
guide catheter until the helix is outside the distal opening of
the guide catheter.
3. Use fluoroscopy to facilitate accurate lead placement.
4. Place one hand on the lead, by the valve, for stability; and,
place the other hand on the lead connector sleeve
(Figure 10). Using the hand on the lead connector sleeve,
rotate the lead body clockwise to affix the helix in the
endocardium. It is recommended that the implanter turn the
lead body approximately 4 to 5 complete (360°) rotations so
that the helix is fully imbedded in the endocardium.
Note: Use either the lead serial number label or the
anchoring sleeve to visually count the number of turns while
using fluoroscopy.
A possible indicator of helix fixation is when
counterclockwise rotation of the lead body is observed when
the hand on the connector sleeve is removed.
Accurate positioning of the electrode is essential for stable pacing
and sensing. A satisfactory position is usually achieved when the
above procedures are followed.
Figure 10.
9.9 Verifying helix electrode fixation
Verify helix electrode fixation:
1. Verify fixation using the proper technique depending on
whether the lead was fixated in the ventricle or atrium:
a. For a ventricular lead: Advance the lead to watch for
slack to build up distal to the catheter to verify fixation. A
properly fixated helix will remain in position. If the helix is
not properly fixated, the lead tip will move into the right
atrium or may become loose.
b. For an atrial lead:Advance the lead to watch for slack
to build up distal to the catheter to verify fixation. Use
frontal fluoroscopy to check for lateral “to-and-fro”
movement of the atrial tip, which reflects atrial and
ventricular contractions. Poor fixation is suspected when
lead tip movement seems random.
2. After confirmation of helix fixation, gently advance the lead
to provide lead slack in the atrium or ventricle to prevent tip
dislodgment. Enough slack is assumed present if, under
fluoroscopy, an atrial lead assumes an “L” shape and a
ventricular lead assumes an “S” shape or “U” shape,
depending on the lead position, during deep inhalation.
Avoid excessive slack buildup that may cause the loop of the
atrial lead to drop near the tricuspid valve.
3. Obtain electrical measurements to verify satisfactory
placement and electrode fixation. Refer to Section 9.10.
4. If a lead must be repositioned or removed, proceed with
caution. Refer to “Repositioning or removing the lead”.
9.10 Taking electrical measurements
Take electrical measurements:
1. Pull the guide catheter back to expose the ring electrode of
the lead so the guide catheter does not interfere with
electrical measurements.
2. Attach the clips of a surgical cable to the lead connector pin
and connector ring.
13
Page 14
3. Use an implant support instrument to obtain electrical
measurements. Medtronic recommends using a pacing
system analyzer. For information on the use of the implant
support instrument, see the product literature for that device.
Satisfactory lead placement is indicated by low stimulation
thresholds and adequate sensing of intracardiac signal
amplitudes.
●
A low stimulation threshold provides for a desirable
safety margin, allowing for a possible rise in thresholds
that may occur within 2 months following implantation.
●
Adequate sensing amplitudes ensure that the lead is
properly sensing intrinsic cardiac signals. Minimum
signal requirements depend on the implantable device’s
sensitivity capabilities. Acceptable acute signal
amplitudes for the lead must be greater than the
minimum implantable device sensing capabilities,
including an adequate safety margin to account for lead
maturity.
Table 6. Recommended measurements at implant
Measurement required Ventricle Atrium
Maximum acute stimulation
thresholds
Minimum acute sensing
amplitudes
a
At a pulse duration setting of 0.5 ms.
a
1.0 V
3.0 mA
5.0 mV 2.0 mV
1.5 V
4.5 mA
4. If electrical measurements do not stabilize to acceptable
levels, repositioning and repeating the testing procedure
may be necessary. Refer to “Acute repositioning or removal
of the lead.”
Note: Initial electrical measurements may deviate from the
recommendations because of acute cellular trauma. If this
occurs, wait 5 to 15 minutes and repeat the testing
procedure. Values may vary depending upon lead type,
implantable device settings, cardiac tissue condition, and
drug interactions.
9.10.1 Checking diaphragmatic stimulation
Diaphragmatic stimulation should also be checked by pacing at
10 V and observing on fluoroscopy whether the diaphragm
contracts with each paced stimulus. If diaphragmatic pacing
occurs, reduce the voltage until a diaphragmatic pacing threshold
is determined. If the diaphragmatic threshold is less than the
required programmed pacing output, the lead should be
repositioned. Refer to “Acute repositioning or removal of the lead.”
9.10.2 Taking pacing impedance (resistance) measurements
Pacing impedance (or resistance) is used to assess implantable
device function and lead integrity during routine implantable
device patient follow-up and to assist in troubleshooting
suspected lead failures. Additional troubleshooting procedures
include ECG analysis, visual inspection, measurement of
thresholds, and electrogram characteristics.
Pacing impedance values are affected by many factors including
lead position, electrode size, conductor design and integrity,
insulation integrity, and the patient’s electrolyte balance.
Apparent pacing impedance is also significantly affected by the
measurement technique. Comparison of pacing impedance
should be done using consistent methods of measurements and
equipment.
An impedance higher or lower than the typical values is not
necessarily a conclusive indication of a lead failure. Other causes
must be considered as well. Before reaching a conclusive
diagnosis, the full clinical picture must be considered. The full
clinical picture includes pacing artifact size and morphology
changes in 12-lead analog ECGs, muscle stimulation with bipolar
leads, sensing and/or capture problems, patient symptoms, and
implantable device characteristics.
Recommendations for clinically monitoring and evaluating leads
in terms of impedance characteristics are listed below.
For implantable devices with telemetry readout of impedance:
●
Routinely monitor and record impedance values at implant
and follow-ups using consistent output settings.
Note: Impedance values may be different at different
programmable output settings (e.g., pulse width or pulse
amplitude) of the implantable device or pacing system
analyzer.
●
Establish a baseline chronic impedance value once the
impedance has stabilized, generally within 6 to 12 months
after implant.
●
Monitor for significant impedance changes and abnormal
values.
●
Where impedance abnormalities occur, closely monitor the
patient for indications of pacing and sensing problems. The
output settings used for measuring impedance should be the
same as that used for the original measurements.
●
For patients at high risk, such as implantable
device-dependent patients, physicians may want to consider
further action such as increased frequency of monitoring,
provocative maneuvers, and ambulatory ECG monitoring.
For implantable devices without telemetry:
●
Record impedance value at implant. Also record the
measurement device, its output settings, and the procedure
used.
●
At the time of implantable device replacement, if pacing
system analyzer system-measured impedance is abnormal,
carefully evaluate lead integrity (including thresholds and
physical appearance) and patient condition before electing to
reuse the lead.
●
Impedances below 250 Ω may result in excessive battery
current drain, which may seriously compromise implantable
device longevity, regardless of lead integrity.
For more information on obtaining electrical measurements,
consult the product literature supplied with the testing device.
14
Page 15
9.11 Acute repositioning or removal of the lead
1
Warning: Successfully repositioning the lead depends on
recreating the angle and advancement of the catheter present at
the time of initial helix deployment at implant (relative to the lead
helix and endocardium). Proper orientation helps transfer torque
to the helix. This increases the likelihood of successfully
disengaging the helix from the endocardium. Improper removal
of the lead by pulling may result in avulsion of the endocardium.
Warning: During the implant procedure, removal of the lead after
fixation may result in avulsion of the endocardium. Anytime a lead
is repositioned or removed, lead junctions may separate leaving
the helix or a portion of the lead in the heart or vein. In most clinical
situations, it is preferable to abandon unused leads in place if this
is a possibility.
Caution: If you determine that the lead requires repositioning,
consider the possibility that the helix may become deformed
and/or entangled as a result of manipulating the lead. Observe
the helix via fluoroscopy or x-ray before attempting to reposition
to determine if the helix shape is intact. If the helix appears
deformed, removal may be difficult and is not recommended.
Note: Failure to recreate the orientation of the catheter, present
at the time of initial helix deployment, may increase the amount
of torque necessary to disengage the helix from the tissue.
9.11.1 Acute repositioning of the lead
Reposition the lead:
1. Recreate the angle and advancement of the catheter present
at the time of initial helix deployment (relative to the lead helix
and endocardium).
2. Rotate the lead body counterclockwise to withdraw the helix
from the implant site if the helix appears intact and
repositioning is required.
Note: The number of counterclockwise rotations needed to
withdraw the helix from the implant site before applying
traction may be greater than the number of revolutions
required for fixation.
Note: If the helix is still imbedded in the endocardium,
additional turns on the lead body should be applied rather
than applying a retraction force.
3. Counterclockwise rotation should be continued throughout
the repositioning process to decrease the possibility of
damage to the cardiovascular tissue.
4. Repeat the ventricular or atrial positioning procedure and the
verifying helix electrode fixation procedure. Use the guide
catheter to reposition the lead.
9.11.2 Acute removal of the lead
Remove the lead:
1. Recreate the angle and advancement of the catheter present
at the time of initial helix deployment (relative to the lead helix
and endocardium).
2. Rotate the lead body counterclockwise to withdraw the helix
from the implant site if the helix appears intact and removal
is required.
Note: The number of counterclockwise rotations needed to
withdraw the helix from the implant site before applying
traction may be greater than the number of revolutions
required for fixation.
Note: If the helix is still imbedded in the endocardium,
additional turns on the lead body should be applied rather
than applying a retraction force.
3. Counterclockwise rotation should be continued throughout
the removal process to decrease the possibility of damage
to the cardiovascular tissue.
4. Remove the lead from the guide catheter while leaving the
guide catheter in place.
5. Verify that the helix electrode is not damaged or deformed
for reuse. Remove any tissue from the helix.
6. See “Inserting the lead into the guide catheter” to implant the
lead. If the lead cannot be implanted, return the lead to
Medtronic for analysis.
9.12 Removing the guide catheter from the lead
Once the lead is in the final position, verify that there is enough
lead slack as recommended in step two of the “Verifying helix
electrode fixation” section. Remove the guide catheter from the
lead before surgical closure. See the delivery system product
literature for details. Repeat electrical measurements, see the
section See “Taking electrical measurements”.
9.13 Anchoring the lead
Caution: Use care when anchoring the lead.
●
Use an anchoring sleeve with all leads.
●
Do not use absorbable sutures to anchor the lead.
●
Do not secure the sutures so tightly that they damage the vein,
lead, or anchoring sleeve.
●
Do not use the anchoring sleeve tabs for suturing (Figure 11 ).
●
Do not tie a suture directly to the lead body (Figure 12).
●
Do not dislodge the lead tip.
●
Do not attempt to remove or cut the anchoring sleeve.
●
Do not remove the tabs on anchoring sleeves. Tabs are
provided to minimize the possibility of the sleeve entering the
vein.
●
Do not allow passage of the anchoring sleeve into the guide
catheter and/or the venous system.
Figure 11.
1 Tab
15
Page 16
Figure 12.
Anchor the lead using all 3 grooves:
1. Position the anchoring sleeve against or near the vein.
2. Secure the anchoring sleeve to the lead body by tying a
suture firmly in each of the 3 grooves (Figure 13 ).
Figure 13.
3. Use at least 1 additional suture in 1 of the grooves to secure
the anchoring sleeve and lead body to the fascia.
9.14 Connecting the lead
Connect the lead to the implantable device according to the
instructions in the implantable device manual.
Connect the lead to the implantable device.
1. Obtain final electrical measurements.
2. Insert the lead connector into the connector block on the
implantable device. For instructions on proper lead
connections, see the product literature packaged with the
implantable device.
9.15 Placing the implantable device and lead into the pocket
Caution: Use care when placing the implantable device and lead
into the pocket.
●
Ensure that the lead does not leave the device at an acute
angle.
●
Do not grip the lead or implantable device with surgical
instruments.
●
Do not coil the lead (Figure 14 ). Coiling the lead can twist the
lead body and may result in lead dislodgment.
Figure 14.
Caution: To prevent undesirable twisting of the lead body, wrap
the excess lead length loosely under the implantable device and
place both into the subcutaneous pocket.
Place the implantable device and lead into the pocket:
1. Rotate the implantable device to loosely wrap the excess
lead length under the implantable device (Figure 15 ).
Figure 15.
2. Insert the implantable device and lead into the pocket.
3. Suture the pocket closed.
4. Monitor the patient’s electrocardiogram until the patient is
discharged. If a lead dislodges, it usually occurs during the
immediate postoperative period.
10 Specifications (nominal)
Parameter Model 3830
Type Bipolar
Chamber Atrium/Ventricle
Fixation Nonretractable screw-in
Length 20–110 cm
Connector IS-1 BI
Material Conductors: MP35N
Connector pin: Stainless steel
Connector ring: Stainless steel
Inner insulator: Silicone rub-
Outer insulator: Polyurethane
Electrode
material
Electrode surface area
Tip to ring
spacing
Lead body
diameter
Catheter
introduction
size
Helix length
(exposed)
Resistance Unipolar: 29 ± 6 Ω (69 cm)
ber/ETFE
Helix: Titanium nitride coated platinum
alloy
Ring: Titanium nitride coated platinum
alloy
Helix: 3.6 mm
Ring: 16.9 mm
2
2
9.0 mm
1.4 mm (4.1 French)
3.0 mm (9.0 French)
1.8 mm
16
Page 17
Parameter Model 3830
Bipolar: 99 ± 22 Ω (69 cm)
Steroid Beclomethasone dipropionate
Amount of steroid (target dose) 17.2 µg
3 Ring electrode surface area: 16.9 mm
4 Anchoring sleeve
5 Lead length: 20–110 cm
6 IS-1 B1 connector
2
Figure 16.
11 Medtronic warranty
For complete warranty information, see the accompanying
warranty document.
12 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 medical
consultation, Medtronic can often refer product users to outside
medical consultants with appropriate expertise. For more
information, contact your local Medtronic representative, or call
or write Medtronic at the appropriate address or telephone
number listed on the back cover.
1 Helix electrode surface area: 3.6 mm
2 Tip to ring spacing: 9.0 mm
2
17
Page 18
Page 19
Page 20
World Headquarters
*M952369A001*
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432
USA
www.medtronic.com
Tel. +1 763 514 4000
Fax +1 763 514 4879
Medtronic USA, Inc.
Toll-free in the USA (24-hour technical consultation for
physicians and medical professionals)
Bradycardia: +1 800 505 4636
Tachycardia: +1 800 723 4636
Europe/Africa/Middle East Headquarters
Medtronic International Trading Sàrl
Route du Molliau 31
Case Postale 84
CH-1131 Tolochenaz
Switzerland
www.medtronic.com
Tel. +41 21 802 7000
Fax +41 21 802 7900
Medtronic E.C. Authorized Representative
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel. +31 45 566 8000
Fax +31 45 566 8668
Technical manuals:
www.medtronic.com/manuals
© Medtronic, Inc. 2013
M952369A001B
2013-01-15
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