Medtronic 4965-15 Technical Manual
CAPSURE® EPI 4965
Steroid eluting, unipolar, epicardial lead
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.
CapSure, Medtronic
Contents
1 Device description 3
2 Accessory descriptions 3
3 Indications 4
4 Contraindications 4
5 Warnings and precautions 4
6 Adverse events 6
7 Clinical studies 9
8 Directions for use 23
9 Detailed device description 30
10 Service 32
11 Medtronic warranty 32
1 Device description
The Medtronic CapSure Epi Model 4965 steroid eluting, unipolar,
epicardial lead is designed for pacing and sensing in either the atrium
or ventricle. Two leads may be used for bipolar pacing.
The porous electrode surface is platinized with platinum black and has
been coated with the steroid dexamethasone sodium phosphate.
The electrode contains a maximum of 1.0 mg of dexamethasone
sodium phosphate, a portion of which is in a silicone rubber binder.
Upon exposure to body fluids, the steroid elutes from the electrode.
Steroid suppresses the inflammatory response that is believed to
cause threshold rises typically associated with implanted pacing
electrodes.
The Model 4965 lead’s silicone suture pad is a triangular shape with 2
suture holes and grooves. The lead also features an MP35N
nickel-alloy conductor, silicone rubber insulation, and a unipolar
connector (IS-11 UNI).
1.1 Contents of package
The lead and accessories are supplied sterile. Each package contains:
●
1 Model 4965 lead
●
1 lead end cap
●
1 tunneler
●
product literature
2 Accessory descriptions
Dispose of all single-use accessories according to local environmental
requirements.
Lead end cap – A seal that is placed on the tip of a lead when the lead
is abandoned in the body to prevent transmission of electrical signals.
1
IS-1 refers to an International Standard (ISO 5841-3) whereby pulse generators
and leads so designated are assured of a basic mechanical fit.
3
Tunneler – A tool used to pass a lead from its point of insertion to the
subcutaneous pocket.
3 Indications
The Model 4965 lead is designed to be used with a pulse generator as
part of a cardiac pacing system. The lead has application where
implantable epicardial atrial or ventricular, single chamber or dual
chamber pacing systems are indicated.
4 Contraindications
●
The lead should not be used on a patient with a heavily infarcted
or fibrotic myocardium. It is also contraindicated for the patient
whose myocardium is suffused with fat.
●
Do not use this device in patients for whom a single dose of 1.0 mg
of dexamethasone sodium phosphate may be contraindicated.
5 Warnings and precautions
Inspecting the sterile package – Inspect the sterile package with
care before opening it.
●
Contact your Medtronic representative if the seal or package is
damaged.
●
Do not store this product above 40 °C (104 °F).
●
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.
Steroid use – It has not been determined whether the warnings,
precautions, or complications usually associated with injectable
dexamethasone sodium phosphate apply to the use of this highly
localized, controlled-release lead. For a list of potential adverse
effects, refer to the Physicians’ Desk Reference.
4
Handling the steroid tip – Reducing the available amount of steroid
may adversely affect low-threshold performance. Avoid reducing the
amount of steroid available prior to lead implant.
●
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 – Before implanting the lead remove the tip
protector.
●
If the lead is damaged, do not implant it. Return the lead to a
Medtronic representative.
●
Protect the lead from materials that shed 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 use surgical instruments to grasp the lead or connector pin.
●
Do not immerse leads in mineral oil, silicone oil, or any other liquid,
except blood, at the time of implant.
Chronic repositioning or removal – Chronic repositioning or
removal of the lead after it has been implanted in the patient is not
recommended. If removal is unavoidable, return the lead to Medtronic.
●
If a lead is abandoned, it should be capped to avoid transmitting
electrical signals from the pin to the heart.
●
A lead that has been cut off should have the remaining lead end
sealed and it should be sutured to adjacent tissue to avoid
migration.
●
Repositioning the lead after it has been implanted may adversely
affect a steroid lead’s low-threshold performance.
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.
5
6 Adverse events
The clinical investigation of the Model 4965 Pacing lead studied 661
devices implanted in 381 patients for a total of 9681 cumulative device
months of experience (3054 Atrial, 6627 Ventricular). Mean duration
of implantation was 14.6 months (range 0 to 62 months). Forty-eight
(48) patients (12.6%) with Model 4965 pacing leads died during the
course of the clinical study. None of the deaths were determined to be
lead related. Lead related adverse events (AEs), including 43
complications (6.5% of leads) and 57 observations (8.6% of leads),
were reported during the clinical investigation. The adverse events that
occurred during more than one time are summarized in Table 1 and
Table 2.
Table 1. Mean duration of implantation is 14.6 months (range 0 - 62 months).
Frequency of adverse events for atrial leads
Type of adverse
event AE
Observations
Muscle stimulation 12 5.4%
Undersensing 6 2.7%
Oversensing 6 2.7%
Elevated thresholds 5 2.2%
Total observa-
a
tions
Complications
(loss of lead)
Lead fracture 5 2.2%
Total complica-
b
tions
a
Observations are adverse events which are corrected by non-invasive
measures (e.g. reprogramming).
b
Complications are adverse events that resulted in loss of the lead function (e.g.
unable to sense or unable to pace the heart).
# of
leads
(n=224)
29 12.9%[8.6
5 2.2%[1.0 -
% of leads
[95% CI]
[2.4 - 8.3%]
[0.6- 4.8%]
[0.6- 4.8%]
[1.0 - 5.2%]
- 17.3%]
[1.0 - 5.2%]
5.2%]
# of
patients
(n=201)
12 6.0%
6 3.0%
6 3.0%
5 2.5%
29 14.4%[9.6
5 2.5%
5 2.5%[1.1 -
% of
patients
[95% CI]
[2.7 - 9.2%]
[0.6 - 5.3%]
[0.6 - 5.3%]
[1.1 - 5.8%]
- 19.3%]
[1.1 - 5.8%]
5.8%]
Table 2. Mean duration of implantation is 14.6 months (range 0 - 62
months).
Frequency of adverse events for ventricular leads
Type of adverse
event AE
Observations
Elevated thresholds
Undersensing 9 2.1%
# of leads
(n=437)
10 2.3%
% of leads
[95% CI]
[0.9 - 3.7%]
[0.7- 3.4%]
# of
patients
(n=355)
10 2.8%
9 2.5%
% of
patients
[95% CI]
[1.1 - 4.5%]
[0.9 - 4.2%]
6
Table 2. Mean duration of implantation is 14.6 months (range 0 - 62
months). (continued)
Frequency of adverse events for ventricular leads
Type of adverse
event AE
# of leads
(n=437)
% of leads
[95% CI]
patients
(n=355)
Observations
# of
Muscle stimulation 7 1.6%
7 2.0%
[0.4 - 2.8%]
Oversensing 2 0.5%
2 0.6%
[0.2- 1.7%]
Total observa-
a
tions
28 6.4%[4.1 -
8.7%]
28 7.9%[5.1 -
Complications
(loss of lead)
Lead fracture 20 4.6%
16 4.5%
[2.6 - 6.5%]
Exit block 6 1.4%
5 1.4%
[0.3 - 2.5%]
Other causes 5 1.1%
4 1.1%
[0.6 - 2.7%]
Elevated pacing
thresholds
Loss of capture 3 0.7%
4 0.9%
[0.4 - 2.4%]
4 1.1%
3 0.8%
[0.3 - 2.0%]
Total complica-
b
tions
a
Observations are adverse events which are corrected by non-invasive
measures (e.g. reprogramming).
b
Complications are adverse events that resulted in loss of the lead function (e.g.
38 8.7%[6.1 -
11.3%]
32 9.0%[6.0 -
unable to sense or unable to pace the heart).
% of
patients
[95% CI]
[0.5 - 3.4%]
[0.2 - 2.1%]
10.7%]
[2.3 - 6.7%]
[0.7 - 3.3%]
[0.5 - 2.9%]
[0.5 - 2.9%]
[0.4 - 2.5%]
12.0%]
There are additional complications related to the use of epicardial
leads that include, but are not limited to, the following:
●
fibrillation
●
heart wall damage
●
cardiac tamponade
●
muscle or nerve stimulation
●
pericardial rub
●
infection
In addition, the lead may not perform optimally in patients with
thin-walled myocardiums.
Another complication, which has been referenced in the literature, is
the potential for increased risk of inducing tachyarrhythmias when
using 2 leads for bipolar pacing. This is thought to be due to the equal
surface area of the anodal and cathodal electrodes. If pacing stimuli
are observed to be falling on the T-wave, it may help to unipolarize the
system.
The potential complications listed above may occur at a higher rate
with the use of these leads in pediatric patients.
7
Typical complications resulting in patient symptoms can often be
resolved as follows in the following chart.
Complication Symptom
Lead dislodgement Intermittent or continu-
Lead conductor fracture
or insulation failure
Threshold elevation or
exit block
a
Transient loss of capture or sensing may occur for a short time following a
surgery until lead stabilization takes place. If stabilization does not occur, lead
dislodgement may be suspected.
ous loss of capture or
a
sensing
Intermittent or continuous loss of capture or
a
sensing
Loss of capture
a
Corrective action to
be considered
Replace the lead
Replace the lead
Adjust the pulse generator output or replace
the lead.
The Model 4965 Pacing Lead post-approval study studied 98 leads
implanted in 73 adult (>19 years old at implant) patients for a total of
2711 months of cumulative device months of experience. Mean
duration of implantation was 27.66 months (range 0 to 146.73 months).
Eighteen (18) patients with Model 4965 Pacing Leads died during the
course of the post-approval study. None of the deaths were
determined to be lead-related. Lead-related events including two
complications (2.04% of leads) and six observations (8.16% of leads)
were reported during the clinical study, Table 3.
Table 3. Frequency of Adverse Events in the Model 4965 Post Approval Study
Type of adverse
event
Reported Observations
Threshold rise, sudden
Pacemaker Syndrome
Lead electrically
abandoned:
Late local ventricle
sensing
Lead surgically abandoned:
RV lead problem 1 1.02%
# of leads
(n=98)
- - - -
1 1.02%
2 2.04%
1 1.02%
% of
leads
[95% CI]
(0.03%,
5.55%)
(0.25%,
7.18%)
(0.03%,
5.55%)
(0.03%,
5.55%)
# of
patients
(n=73)
1 1.37%
1 1.37%
1 1.37%
1 1.37%
% of
patients
[95% CI]
(0.03%,
7.40%)
(0.03%,
7.40%)
(0.03%,
7.40%)
(0.03%,
7.40%)
8
Table 3. Frequency of Adverse Events in the Model 4965 Post
Approval Study (continued)
Type of adverse
event
Lead surgically abandoned:
System upgrade 1 1.02%
Lead surgically abandoned:
Unspecified 2 2.04%
Total observations 8 8.16%
Lead Related Complications
Failure to capture 1 1.02%
Lead conductor fracture
Total complications 2 2.04%
# of leads
(n=98)
1 1.02%
% of
leads
[95% CI]
(0.03%,
5.55%)
(0.25%,
7.18%)
(3.59%,
15.45%)
(0.03%,
5.55%)
(0.03%,
5.55%)
(0.25%,
7.18%)
# of
patients
(n=73)
1 1.37%
1 1.37%
6 8.22%
1 1.37%
1 1.37%
2 2.74%
% of
patients
[95% CI]
(0.03%,
7.40%)
(0.03%,
7.40%)
(0.03%,
7.40%)
(0.03%,
7.40%)
(0.03%,
7.40%)
(0.33%,
9.55%)
For a Model 4965 survival estimate generated from the Medtronic
active prospective surveillance study, refer to the CRDM Product
Performance Report. This report is available
at www.Medtronic.com/CRDMProductPerformance.
7 Clinical studies
7.1 Model 4965 Clinical Study summary of clinical results
The Model 4965 lead was studied in 381 patients who received 661
leads for a total of 9681 device months experience. Six hundred (600)
of these leads were implanted in 349 pediatric patients and 61 leads
were implanted in 32 adult patients. Data were collected prospectively
at 2 weeks and 1, 3, 6, 9, and 12 months post implant at 56 investigative
centers. The median patient age for the pediatric population was 2.3
years (range 0 - 18.6 years); 57.3% of the pediatric patients were male.
For the adult population, the median patient age was 34.3 (range 19.2 -
79.6 years); 46.9% of the adult patients were male.
7.1.1 Primary objectives
Primary objective one – To demonstrate the safety of the Model 4965
lead by measuring Loss of Lead survival performance in four
categories. The categories were loss of lead due to 1) Conductor Coil
Fracture (Fx) 2) Fx plus Loss of Capture (LOC) 3) Fx, LOC plus
9
Elevated Thresholds (ET) and Exit Block (EB) 4) Overall loss of lead
(Fx, LOC, ET, EB plus “loss of sensing” and “other”). See Table 5.
Primary objective two – To demonstrate the effective acute and
chronic pacing and sensing performance of the Model 4965 lead by
measuring electrical threshold performance of the device.
Results:2 Patients in the study who received the Model 4965 device
via a left thoracotomy surgical approach were found to have a
statistically higher risk of lead fracture than those patients treated with
other surgical approaches (p<0.01). A comparison of surgical implant
techniques for the effect on lead fracture is shown in Table 4.
Table 4. A Cox Regression with a covariate of surgical technique for
effect on fracture of pediatric leads was used to calculate the risk
associated with each type of surgical technique. No effect is noted by
a confidence interval of the risk ratio which contains 1.
Number Frac-
Implant technique
Median sternotomy 2/250 (0.8%)
Subxiphoid 4/149 (2.7 %)
Left thoracotomy 17/157 (10.8%)
Subcostal 1/16 (6.3%)
Other 1/22 (4.5%)
tured/Total (%) [95%
C.I.] Risk Ratio [95% C.I.]
0.1 [0.03 - 0.6]
[0.2 - 2.9%]
0.6 [0.2 - 1.8]
[1.1 - 6.8%]
5.2 [2.2 - 12.3]
[6.0 - 15.7%]
2.9 [0.4 - 22.8]
[1.5 - 30.3%]
0.5 [0.06 - 3.9]
[1.1 - 22.9%]
The Model 4965 lead demonstrated acceptable survival rates at 12
months in the four identified categories:
Table 5. Loss of lead survival performance in pediatric patients (n=594 leads).
Category 12 month survival
Coil fractures 96.3%
Coil fractures + Loss of capture 95.5%
Coil fractures + Loss of capture + Elevated
thresholds + Exit block
Overall loss of lead 93.6%
94.8%
Pacing and sensing thresholds were also found to be acceptable.
Furthermore, the Model 4965 lead demonstrated no peaking
phenomenon in the acute phase of implantation and had low, stable,
chronic stimulation thresholds.
2
Data presented are from the pediatric cohort only.
10
The lead performance of the primary outcome study variables is
Follow-up time in months (Implant at month 0)
Unipolar atrial pulse width thresholds at 2.5 V in the pediatric
cohort
Threshold in ms
Follow-up time in months (Implant at month 0)
Unipolar ventricular pulse width thresholds at 2.5 V in the pediatric
cohort
Threshold in ms
represented graphically on the following pages. The electrical data
presented in Figure 1 through Figure 4, followed by Kaplan-Meier
survival curves that display the safety performance of the Model 4965
lead in Figure 5 through Figure 8 .
Figure 1. Unipolar atrial pulse width thresholds at 2.5 V, Mean ± 1.5 standard error of the mean (SEM), n displayed at each data point. Pediatric patients with unipolar atrial leads: n-total=178.
Figure 2. Unipolar ventricular pulse width thresholds at 2.5 V, Mean ±
1.5 standard error of the mean (SEM), n displayed at each data point.
Pediatric patients with unipolar ventricular leads: n-total=320.
11
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