Medtronic 6937A-35 Technical Manual

TRANSVENE® -CS/SVC 6937A

Unipolar, endocardial, CS/SVC lead

Technical manual

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

Table of contents

Device description 1

Contents of package 1 Accessory descriptions 1

Indications for use 1

Contraindications 2

Warnings and precautions 2

Adverse events 4

Observed adverse events 4 Potential adverse events 5

Clinical studies 5

Directions for use 7

Opening the sterile package 7 Inserting the lead 7 Positioning the lead in the superior vena cava 9 Positioning the lead in the coronary sinus 9 Taking defibrillation efficacy measurements 10 Anchoring the lead 11 Connecting the lead 12 Placing the device and lead into the pocket 12 Post-implant evaluation 13

Detailed device description 14

Specifications (nominal) 14 Specifications drawings (nominal) 15

Special notice 16

Service 16

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Device description

The Medtronic Transvene-CS/SVC Model 6937A Unipolar, endocardial lead is designed for delivering cardioversion and defibrillation therapies in either the coronary sinus or superior vena cava. Silicone insulation with a polyurethane overlay surrounds the low resistance conductor coil and the coil electrode is a platinum alloy. The lead has a DF-1 section "Detailed device description."

Contents of package

The lead and accessories are provided sterile. Each package contains the following:

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One lead with one2 radiopaque anchoring sleeve, stylet, and stylet guide

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One vein lifter

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Extra stylets

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Product literature

Accessory descriptions

Stylets – A stylet provides additional stiffness and controlled

flexibility for maneuvering the lead into position. Each stylet knob is labeled with the stylet diameter and length. Curving the stylet prior to insertion into the lead will achieve a curvature at the lead’s distal end.

Stylet guide – A stylet guide facilitates stylet insertion into the lead. A notch in the stylet guide allows connection of a surgical cable for electrical measurements.

Anchoring sleeves – An anchoring sleeve secures the lead from moving and protects the lead insulation and conductors from damage caused by tight ligatures. An anchoring sleeve is radiopaque for visualization on standard X-ray equipment.

Vein lifter – A vein lifter facilitates lead insertion into a vessel.

connector. For further information, refer to the

Indications for use

The lead is intended for single long-term use in the coronary sinus or superior vena cava for delivering atrial cardioversion and defibrillation therapies.

The lead has application for patients in which implantable cardioverter defibrillators are indicated.

DF-1 refers to the International Connector Standard (ISO 11318) whereby pulse generators and leads so designated are assured of a basic mechanical fit.

Two anchoring sleeves are provided with leads of 85 cm or longer.

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Note: Prior to lead implant, it is strongly recommended that patients undergo a complete cardiac evaluation, which should include extensive electrophysiologic testing. Also, extensive electrophysiologic evaluation and testing of the safety and efficacy of the proposed pacing, cardioversion, or defibrillation therapies are recommended during and after the implantation of the system.

Contraindications

Arrhythmia types – The lead is contraindicated for patients with any

of the following conditions:

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Transient ventricular tachyarrhythmias due to reversible causes, such as drug intoxication, electrolyte imbalance, sepsis, or hypoxia.

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Transient ventricular tachyarrhythmias due to other factors, such as myocardial infarction and electrocution.

Warnings and precautions

Inspecting the sterile package – Carefully inspect the package

prior to opening:

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If the seal or package is damaged, contact your local Medtronic representative.

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Do not use the product after its expiration date.

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The lead has been sterilized with ethylene oxide prior to shipment. If the integrity of the sterile package has been compromised prior to the expiration date, resterilize using ethylene oxide.

Ethylene oxide resterilization – If the sterile package seal is broken, resterilize the device using a validated ethylene oxide process. Avoid resterilization techniques that could damage the lead:

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Refer to sterilizer instructions for operating instructions.

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Use an acceptable method for determining sterilizer effectiveness, such as biological indicators.

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Before resterilization, place the device in an ethylene oxide permeable package.

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Do not exceed temperatures of 55°C (130°F).

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Do not resterilize more than one time.

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After resterilization, allow the device to aerate ethylene oxide residues.

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Handling the lead – Leads should be handled with great care at all times:

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Protect the lead from materials shedding particles such as lint and dust. Lead insulators attract these particles.

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Handle the lead with sterile surgical gloves that have been rinsed in sterile water or a comparable substance.

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Do not severely bend, kink, or stretch the lead.

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Do not use surgical instruments to grasp the lead or connector pins.

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Do not immerse leads in mineral oil, silicone oil, or any other liquid, except blood at the time of implantation.

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Inserting the lead using a lead introducer that features a hemostasis valve may require a larger introducer than the size recommended. Do not withdraw the lead through a hemostasis valve, to avoid distortion of the coil electrode.

Handling the stylets – Use care when handling stylets:

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Do not use excessive force or surgical instruments when inserting a stylet.

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Avoid overbending, kinking, or blood contact.

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Use a new stylet when blood or other fluids accumulate on the stylet. Repeated insertions of a stylet increases the probability that blood or other fluids may accumulate on the stylet, which may cause difficulty in passing the stylet through the lead or damage to the lead.

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Do not use a sharp object to impart a curve to the distal end of the stylet, to avoid damage to the stylet.

Necessary hospital equipment – Keep external defibrillation equipment nearby for immediate use during the acute lead system testing, implantation procedure, or whenever arrhythmias are possible or intentionally induced during post-implant testing.

Line-powered equipment – An implanted lead forms a direct current path to the myocardium. During lead implantation 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.

Second anchoring sleeve – For leads 85 cm or longer, which feature two anchoring sleeves, use both anchoring sleeves as described in the “Anchoring the lead” section, to assure adequate fixation.

Chronic repositioning or removal – Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development. Return all removed or unused leads to Medtronic. If a lead must be removed or repositioned, proceed with extreme caution:

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Removal of the lead may result in avulsion of the endocardium, valve, or vein.

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If a lead is abandoned, it should be capped to avoid transmitting electrical signals.

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A lead that has been cut off should have the remaining lead end sealed, and the lead should be sutured to adjacent tissue to avoid migration into the heart.

Connector compatibility – Although the lead conforms to the International Connector Standard DF-1, do not attempt to use the Model 6937A lead with any device other than a commercially available implantable defibrillator system with which it has been tested and demonstrated to be safe and effective. The potential adverse consequences of using such a combination may include, but are not limited to, undersensing cardiac activity and failure to deliver necessary therapy.

Adverse events

Observed adverse events

The Transvene-CS/SVC Model 6937A Unipolar, endocardial, CS/ SVC lead was utilized in the SVC and coronary sinus during the Model 7250 Jewel patients who received a Model 7250 AF Implantable Cardioverter Defibrillator received a Model 6937A lead in either the coronary sinus or the SVC. Individual patient implant time averaged 12.8 months, with a range of 0.1 to 24.7 months.

Eight patient deaths occurred in this group of patients. All deaths were reviewed and judged to be non-system related by an independent advisory committee. The deaths were attributed to: congestive heart failure (3), ischemic cardiomyopathy (1), cardiomyopathy (1), hypoxic encephalopathy (1), lung cancer (1) and cardiogenic shock/respiratory failure (1).

Lead-related complications and lead-related observations are summarized in Table 1:

Tab le 1 . Lead-related complications and observationsa all patients (N = 114)

Complications

Lead dislodgment 3 3

To t al 3 3

Observations

Subclavian vein thrombosis 1 1

To t a l 1 1

database closure: 5/31/2000

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AF clinical study. One hundred fourteen of 676

# of events # of patients

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