Medtronic 4968-60 Technical Manual

CAPSURE® EPI 4968

Steroid eluting, bipolar, epicardial lead

Technical Manual

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

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CapSure, Medtronic

1 Device description 3 2 Accessory descriptions 3 3 Indications for use 4 4 Contraindications 4 5 Warnings and precautions 4 6 Adverse events 5 7 Clinical study 8 8 Directions for use 18

9 Specifications (nominal) 25 10 Service 27 11 Medtronic warranty 27

1 Device description

The Medtronic CapSure Epi Model 4968 steroid eluting, bipolar, epicardial lead is designed for pacing and sensing in either the atrium or ventricle.

The porous electrode surfaces are platinized with platinum black and have been coated with the steroid dexamethasone sodium phosphate.

Each 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 4968 lead’s silicone suture pads are triangular shapes with 2 suture holes and grooves. The lead also features an MP35N nickel-alloy conductor, silicone rubber insulation, and a bipolar connector (IS-1 BI)1.

1.1 Contents of package

The lead and accessories are supplied sterile. Each package contains:

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1 Model 4968 lead

●

1 lead end cap

●

1 tunneler

●

product documentation

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.

IS-1 refers to an International Standard (ISO 5841-3) whereby pulse generators and leads so designated are assured of a basic mechanical fit.

Tunneler – A tool used to pass a lead from its point of insertion to the subcutaneous pocket.

3 Indications for use

The Model 4968 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 two single doses 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.

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.

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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.

6 Adverse events

Due to the similarity in design and function, Model 4965 unipolar clinical data supports the safety and efficacy claims for the Model 4968 lead and is included here for reference purposes.

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

Observations

Muscle stimulation

Undersensing 6 2.7%

Oversensing 6 2.7%

Elevated thresholds

Total obser-

vations

Complications (loss of lead)

Lead fracture 5 2.2%

Total compli-

cations

Observations are adverse events which are corrected by non-invasive measures (e.g. reprogramming).

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)

12 5.4%

5 2.2%

29 12.9%

5 2.2%

% of leads [95% CI]

[2.4 - 8.3%]

[0.6- 4.8%]

[1.0 - 5.2%]

[8.6 - 17.3%]

[1.0 - 5.2%]

# of patients (n=201)

12 6.0%

6 3.0%

5 2.5%

29 14.4%

5 2.5%

% of patients [95% CI]

[2.7 - 9.2%]

[0.6 - 5.3%]

[1.1 - 5.8%]

[9.6 - 19.3%]

[1.1 - 5.8%]

Table 2. Mean duration of implantation is 14.6 months (range 0 - 62 months).

Frequency of adverse events for ventricular leads

# of

leads Type of adverse event AE

(n=437)% of leads

[95% CI]

Observations

Elevated thresholds

10 2.3%

[0.9 - 3.7%]

Undersensing 9 2.1%

[0.7- 3.4%]

Muscle stimulation 7 1.6%

[0.4 - 2.8%]

Oversensing 2 0.5%

[0.2- 1.7%]

Total observa-

tions

28 6.4%[4.1 -

8.7%]

Complications (loss of lead)

Lead fracture 20 4.6%

[2.6 - 6.5%]

Exit block 6 1.4%

[0.3 - 2.5%]

Other causes 5 1.1%

[0.6 - 2.7%]

Elevated pacing thresholds

4 0.9%

[0.4 - 2.4%]

Loss of capture 3 0.7%

[0.3 - 2.0%]

Total complica-

tions

Observations are adverse events which are corrected by non-invasive measures (e.g. reprogramming).

Complications are adverse events that resulted in loss of the lead function (e.g.

38 8.7%[6.1 -

11.3%]

unable to sense or unable to pace the heart).

# of patient s (n=355)% of patients

[95% CI]

10 2.8%

[1.1 - 4.5%]

9 2.5%

[0.9 - 4.2%]

7 2.0%

[0.5 - 3.4%]

2 0.6%

[0.2 - 2.1%]

28 7.9%[5.1 -

10.7%]

16 4.5%

[2.3 - 6.7%]

5 1.4%

[0.7 - 3.3%]

4 1.1%

[0.5 - 2.9%]

4 1.1%

[0.5 - 2.9%]

3 0.8%

[0.4 - 2.5%]

32 9.0%[6.0 -

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.

The potential complications listed above may occur at a higher rate with the use of these leads in pediatric patients.

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

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

sensing

Intermittent or continuous loss of capture or

sensing

Loss of capture

Corrective action to be considered

Replace the lead

Adjust the pulse generator output or replace the lead.

7 Clinical study

7.1 Model 4968 Post Approval Study

Study title: Model 4968 Post Approval Study

Product: Medtronic Model 4968 CapSure Epi Steroid-Eluting Bipolar

Epicardial Pacing Lead

Number of centers: 86

Number of subjects: 370 enrolled

Table 3. Study summary

Number of subjects 370 subjects

Number of subjects with ≥ five years of follow-up 101 subjects

Cumulative Device Experience 179.2 months

1st Quartile Device Experience 10.5 months

Median Device Experience 26.7 months

3rd Quartile Device Experience 59.6 months

Number of Enrolling Centers 86

Final Report Data Cut Off Date 02 March 2010

7.1.1 Study objective

Medtronic conducted the Model 4968 Post Approval Study to perform long-term surveillance on the Model 4968 CapSure Epi Steroid-Eluting Bipolar Epicardial Pacing Lead. This study was required by the FDA as part of the requirement to satisfy the PMA conditions of product approval.

7.1.2 Study design

The Model 4968 Post Approval Study was a prospective non-randomized, multicenter study conducted at 86 centers in the United States, Canada, Europe, and Australia. The study required 100 subjects to be enrolled and followed for 5 years post implant. Data for the 4968 Post Approval Study was collected following the Medtronic System Longevity Study protocol.

7.1.3 Subject population

Subjects who met the following inclusion/exclusion criteria were eligible for enrollment into the study.

Inclusion criteria:

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Provision of written informed consent and/or authorization for access to and use of health information by subjects or appropriate legal guardians as required by an institution’s Investigational Review Board, Medical Ethics Board, or Research Ethics Board

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Availability of implant, follow-up and product-related event data

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Implanted with a Model 4968 lead actively being used for pacing or sensing application

Exclusion criteria

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Subjects who received an implant at a non-participating center and data cannot be confirmed within 30 days after implant

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Subjects inaccessible for follow-up at a study center

●

Subjects with exclusion criteria required by local law (EMEA only)

Table 4. Subject Demographics

Category Data Type Statistics

Age n 349

Mean 30

Minimum 0

STD 29

Q1 5

Median 15

Q3 60

Maximum 86

Gender Female 138 (37.3%)

Male 232 (62.7%)

Race Black or African

American

Race/Ethnicity not collected in previous study protocol

Hispanic or Latino 1 (0.3%)

Not reportable per local laws or regulation

Other 1 (0.3%)

White 16 (4.3%)

5 (1.4%)

345 (93.2%)

2 (0.5%)

Table 5. Summary of Subject Demographics by Age Group

Baseline demographics category

n 21 155 49 145

Unknown 0–12 13–19 20+

Age Group

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