Medtronic 6946M97 Technical Manual

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SPRINT QUATTRO® 6946M
Dexamethasone acetate steroid eluting, quadripolar, ventricular lead with tined tip and RV/SVC defibrillation coil electrodes
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.
AccuRead, Medtronic, Sprint Quattro, Tensi-Lock
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Contents

1 Device description 3 2 Drug component description 3 3 Indications 4 4 Contraindications 4 5 Warnings and precautions 4 6 Potential adverse events 5 7 Clinical data 6 8 Drug information 6
9 Directions for use 7 10 Specifications (nominal) 11 11 Medtronic warranty 12 12 Service 12 13 Explanation of symbols on package labeling 12

1 Device description

The Medtronic Sprint Quattro Model 6946M lead is a steroid-eluting, quadripolar, tined tip, ventricular lead with right ventricular (RV) and superior vena cava (SVC) defibrillation coil electrodes. This lead is designed for pacing, sensing, cardioversion, and defibrillation therapies.
The lead features tines, silicone insulation with overlay, parallel conductors, tip and ring electrodes, and RV and SVC coils. The lead also features Tensi-Lock1 and silicone-backfilled defibrillation coils.
The DF4-LLHH2 four-pole HV inline connector on the lead facilitates device connection during implant. The DF4 connector pin has a color band indicator that may be used to visually confirm proper connection to the device.
The RV and SVC coils deliver cardioversion and defibrillation therapies. Pacing and sensing occur between the tip and ring electrodes. An AccuRead analyzer cable interface tool (ACI tool) is attached to the lead to facilitate accurate electrical measurements during implant.
The tip electrode contains a steroid-eluting plug that contains dexamethasone acetate. The tip electrode contains a nominal dosage of 272 µg of dexamethasone acetate. Upon exposure to body fluids, the steroid elutes from the lead tip. The steroid is known to suppress the inflammatory response that is believed to cause threshold rises typically associated with implanted pacing electrodes.

1.1 Package contents

Leads and accessories are supplied sterile. Each package contains the following items:
1 lead with a radiopaque anchoring sleeve3, stylet, and AccuRead tool
1 purple stylet guide
1 slit anchoring sleeve
1 vein lifter
extra stylets
product literature

1.2 Accessory descriptions

AccuRead analyzer cable interface (ACI) tool – The ACI tool
facilitates accurate electrical measurements during implant and prevents possible connector damage.
Anchoring sleeve – An anchoring sleeve secures the lead to prevent it from moving and protects the lead insulation and conductors from damage caused by tight sutures.
Purple stylet guide – A stylet guide facilitates stylet insertion into the lead.
Slit anchoring sleeve – A slit anchoring sleeve secures excess lead length in the device pocket.
Stylet – A stylet provides additional stiffness and controlled flexibility for maneuvering the lead into position. Each stylet knob is labeled with the stylet diameter and corresponding lead length.
Vein lifter – A vein lifter facilitates lead insertion into a vein.

2 Drug component description

The active ingredients in the Model 6946M lead is dexamethasone acetate 9-Fluoro-11β, 17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione 21-acetate. The structural formula for this steroid is shown below:
Dexamethasone acetate is a white to off-white, odorless powder (USP) that is a practically insoluble in aqueous solutions. Dexamethasone acetate is a synthetic adrenocortical steroid produced by the esterification of dexamethasone.
Structural formula for dexamethasone acetate (DXAC) ­C24H31FO
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1
Tensi-Lock is an exclusive Medtronic design feature that utilizes lead body cables to act like a built-in locking stylet and add tensile strength to the lead.
2
DF4-LLHH refers to the International Connector Standard ISO 27186:2010, where the lead connector contacts are defined as low voltage (L) or high voltage (H).
3
Two radiopaque anchoring sleeves are provided on leads that are 85 cm or longer.
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Figure 1.
The nominal dosage of dexamethasone acetate is 272 µg per lead.

3 Indications

The lead is intended for single, long-term use in the right ventricle.
This lead has application for patients for whom implantable cardioverter defibrillators (ICDs) are indicated.

4 Contraindications

Atrial use – The lead is contraindicated for the sole use of
detection and treatment of atrial arrhythmias.
Ventricular use – The lead is contraindicated for ventricular use in patients with tricuspid valvular disease or a tricuspid mechanical heart valve.
Transient ventricular tachyarrhythmias – The lead is contraindicated for patients with transient ventricular tachyarrhythmias due to reversible causes (drug intoxication, electrolyte imbalance, sepsis, hypoxia) or other factors (myocardial infarction, electric shock).
Steroid use – The lead is contraindicated in patients for whom a single dose of 272 µg of dexamethasone acetate may be contraindicated.

5 Warnings and precautions

Inspecting the sterile package – Inspect the sterile package
with care before opening it.
Contact a 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.
Single use – The lead and accessories are for single use only.
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.
Connector compatibility – Although the lead conforms to the International Connector Standard for DF4, do not attempt to use the 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.
Electrophysiologic testing – Prior to lead implant, it is strongly recommended that patients undergo a complete cardiac evaluation, which should include electrophysiologic testing. Also, electrophysiologic evaluation and testing of the safety and efficacy of the proposed pacing, cardioversion, or defibrillation therapies are recommended during and after the implant of the system.
Steroid use – It has not been determined whether the warnings, precautions, or complications usually associated with injectable dexamethasone acetate 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 – Avoid reducing the amount of steroid available before implanting the lead. 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.
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 pins.
Do not immerse the lead in mineral oil, silicone oil, or any other liquid, except blood, at the time of implant.
Inserting the lead using a lead introducer that has a hemostasis valve may require a larger introducer than the size recommended. To avoid distortion of the coil electrode, do not withdraw the lead through a hemostasis valve.
Handling the stylet – Handle the stylet with care at all times.
Do not use a sharp object to impart a curve to the distal end of the stylet.
Do not use excessive force or surgical instruments when inserting the stylet into the lead.
Avoid overbending or kinking the stylet.
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Use a new stylet when blood or other fluids accumulate on the stylet. Accumulated blood or other fluids may damage the lead or cause difficulty in passing the stylet into the lead.
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.
Second anchoring sleeve – Leads that are 85 cm or longer include 2 anchoring sleeves. Use both anchoring sleeves to assure adequate fixation.
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.
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 lead system. Therapeutic ultrasound (including physiotherapy, high intensity therapeutic ultrasound, and high intensity focused 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 lead system, as long as the ultrasonic beam is pointing away from the device and lead system.
Chronic repositioning or removal – Chronic repositioning or removal of leads may be difficult because of fibrotic tissue development. Return all removed leads, or lead segments, to
Medtronic. If a lead must be removed or repositioned, proceed with extreme caution.
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 may adversely affect the low-threshold performance of a steroid-eluting lead.
An abandoned lead should be capped so that the lead does not transmit electrical signals.
Severed leads should have the remaining lead end sealed and the lead body sutured to adjacent tissue.
AccuRead tool – The AccuRead tool reduces the risk of connector damage, and reduces the risk of bridging and shorting that may occur while taking electrical measurements during implant. The potential for connector damage, bridging, and shorting is due to variations in analyzer cable terminals, as well as to the connector ring width and the proximity of the rings on the DF4 connector.

6 Potential adverse events

Potential adverse events – The potential adverse events
associated with the use of transvenous leads and pacing systems include, but are not limited to, the following events:
acceleration of tachyarrhythmias (caused by device)
air embolism
bleeding
body rejection phenomena, including local tissue reaction
cardiac dissection
cardiac perforation
cardiac tamponade
chronic nerve damage
constrictive pericarditis
death
device migration
endocarditis
erosion
excessive fibrotic tissue growth
extrusion
fibrillation or other arrhythmias
fluid accumulation
formation of hematomas/seromas or cysts
heart block
heart wall or vein wall rupture
hemothorax
infection
keloid formation
lead abrasion and discontinuity
lead migration/dislodgement
mortality due to inability to deliver therapy
muscle and/or nerve stimulation
myocardial damage
myocardial irritability
myopotential sensing
pericardial effusion
pericardial rub
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pneumothorax
poor connection of the lead to the device, which may lead to oversensing, undersensing, or a loss of therapy
threshold elevation
thrombosis
thrombotic embolism
tissue necrosis
valve damage (particularly in fragile hearts)
venous occlusion
venous perforation
Other potential adverse events related to the lead include, but are not limited to, the following conditions:
insulation failure
lead conductor or electrode fracture
Additional potential adverse events associated with the use of ICD systems include, but are not limited to, the following events:
inappropriate shocks
potential mortality due to inability to defibrillate
shunting current or insulating myocardium during defibrillation

7 Clinical data

Clinical study data – Clinical data from the Model 6947 and 4074
leads support the safety and efficacy of the Model 6946M lead. The Model 6946M lead is a passive fixation model of the Medtronic Sprint Quattro lead family, combining the Sprint Quattrol lead body and the electrode tip of the Model 4074 lead. The Model 6946M lead includes a combination of components used in currently marketed Medtronic leads with some enhancements.
All functional features of the Model 6946M lead have been approved in these currently marketed Medtronic leads. Previous clinical studies have shown leads with titanium nitride coated electrodes, as used on Model 6946M, have clinically acceptable pacing thresholds and sensing amplitudes. The length and spacing of the defibrillation electrodes are identical to currently approved Spring Quattro leads Model 6947 and Model 6947M. Based upon its similarity to the Model 6947 and Model 4074 leads, the clinical data from these lead models support the safety and efficacy of the Model 6946M lead. These relationships are summarized in the following table.

Table 1. Features supported

DF4 Model 6946M features:
RV/SVC defibrillation electrodes RV/SVC defibrillation electrodes
Ring electrode for true bipolar sensing
Steroid eluting in a defibrillation lead
Silicone insulation with polyur­ethane overlay
Sprint Quattro Model 6947 clin­ical data supports:
Ring electrode for true bipolar sensing
Steroid eluting in a defibrillation lead
Silicone insulation with polyur­ethane overlay
Table 1. Features supported (continued)
Standarda electrode spacing Standard electrode spacing
DF4 Model 6946M features: Capsure Sense Model 4074
Tip electrode material, titanium nitride
Ring electrode material, titanium nitride
Use of steroid-eluting plug Use of steroid-eluting plug
Passive fixation - tines Passive fixation - tines
a
8 mm tip to ring spacing, 12 mm tip to RV coil spacing
clinical data supports:
Tip electrode material, titanium nitride
Ring electrode material, titanium nitride
For more information about the clinical data of these leads, you can get printed copies of the Model 6947 and Model 4074 technical manuals from your Medtronic representative, or you can call the toll-free number located on the back cover of this manual.
Information regarding the Model 6947 lead and Model 4074 lead clinical study is also available on the Medtronic website. To view, download, print, or order the Model 6947 and Model 4074 technical manual from the website, perform the following steps:
1. Navigate your Web browser to http://www.medtronic.com/manuals.
2. Select the United States hyperlink.
3. Select the radio button for “by Model Number” and type “6947” or “4074”.
4. Select one of the items from the drop-down list. Click Go. A list of all technical literature for this device appears including clinical summaries.

8 Drug information

8.1 Steroid mechanism of action

Steroid suppresses the inflammatory response that is believed to cause threshold rises typically associated with implanted pacing electrodes. Dexamethasone acetate is a synthetic steroid of the glucocorticoid family. Glucocorticoids have potent anti-inflammatory actions via direct and indirect effects on major inflammatory cells. Glucocorticosteroids bind to a cytoplasmic glucocorticoid receptor as well as 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 within the regulatory regions of affected genes. Thus, glucocorticoids inhibit the production of multiple cell factors that are critical in generating the inflammatory response.

8.2 Pharmacodynamics of the Model 6946M lead

Pharmacokinetics – The pharmacokinetics (local drug levels
and systemic levels) of dexamethasone acetate (DXAC) and its metabolites following lead implantation were not evaluated in human clinical trials.
Metabolism – The conversion of DXAC to dexamethasone occurs within hours. The dexamethasone alcohol (dexamethasone) is the active glucocorticoid used in Medtronic leads. Steroid is applied to the tip and eluted through the electrode
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tip to the tissue interface where it will be used. Dexamethasone
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acetate is hydrolyzed into dexamethasone, which is readily absorbed by the surrounding tissue and body fluids. Glucocorticoids, when given systemically, are eliminated primarily by renal excretion of inactive metabolites.
Mutagenesis, carcinogenicity and reproductive toxicology –
The mutagenesis, carcinogenicity, and reproductive toxicity of the Model 6946M lead have not been evaluated. However, the mutagenesis, carcinogenicity, and reproductive toxicity of dexamethasone acetate has been evaluated previously.
Carcinogenesis, mutagenesis, impairment of fertility – No adequate studies have been conducted in animals to determine whether corticosteroid have a potential for carcinogenesis (tumor initiation or promotion). Dexamethasone was genotoxic in assays for clastogenicity (including sister chromatid exchange in human lymphocytes) but not in an assay for mutagenicity in salmonella (Ames test).
Adrenocorticoids have been reported to increase or decrease the number and mobility of spermatozoa in some patients.
Pregnancy – Pregnancy category C. Dexamethasone acetate has been shown to be teratogenic in many species when given in doses equivalent to the human dose. There are no adequate and well-controlled studies in pregnant women. Dexamethasone acetate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Studies in mice, rats, and rabbits have shown that adrenocorticoids increase the incidence of cleft palate, placental insufficiency, and spontaneous abortions, and can decrease the intrauterine growth rate.
Nursing mothers – Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects in nursing infants. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to discontinue nursing or to use a non-steroidal lead, taking into account the importance of the lead and the drug to the mother.
Connecting the lead
Placing the device and lead into the pocket

9.1 Opening the package

Use the following steps to open the sterile package and inspect the lead:
1. Within the sterile field, open the sterile package and remove the lead and accessories.
2. Inspect the lead. Leads that are shorter than 85 cm should have 1 anchoring sleeve on the lead body. Leads that are 85 cm or longer should have 2 anchoring sleeves on the lead body.

9.2 Inserting the lead

Caution: Use care when handling the lead during insertion.
Do not severely bend, kink, or stretch the lead.
Do not use surgical instruments to grasp the lead or connector pins.
Insert the lead using the following techniques:
1. Select a site for lead insertion. The lead may be inserted by venotomy through several different venous routes, including the right or left cephalic vein, the subclavian vein, or the external or internal jugular vein. Use the cephalic vein whenever possible to avoid lead damage in the first rib or clavicular (thoracic inlet) space.
Cautions:
Certain anatomical abnormalities, such as thoracic outlet syndrome, may also precipitate pinching and subsequent fracture of the lead.
When using a subclavian approach, avoid techniques that may damage the lead.
Place the insertion site as far lateral as possible to avoid clamping the lead body between the clavicle and the first rib (Figure 2).
Figure 2.

9 Directions for use

Proper surgical procedures and sterile techniques are the responsibility of the medical professional. The following procedures are provided for information only. Some implant techniques vary according to physician preference and the patient’s anatomy or physical condition. Each physician must apply the information in these instructions according to professional medical training and experience.
The implant procedure generally includes the following steps:
Opening the package
Inserting the lead
Positioning the lead
Taking electrical measurements and defibrillation efficacy measurements
Anchoring the lead
1 Suggested entry site
Do not force the lead if significant resistance is encountered during lead passage.
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Do not use techniques such as adjusting the patient’s posture to facilitate lead passage. If resistance is encountered, it is recommended that an alternate venous entry site be used.
2. Insert the tapered end of a vein lifter into the incised vein and gently push the lead tip underneath and into the vein (Figure 3). Note: A percutaneous lead introducer (PLI) kit may be used to facilitate insertion. If an introducer is used, it should be at least 3.0 mm (9 French). Refer to the technical manual packaged with an appropriate percutaneous lead introducer for further instructions.
Figure 3.
3. Advance the lead into the right atrium using a straight stylet to facilitate movement through the veins.

9.3 Positioning the lead

Caution: Use care when handling the lead during positioning.
Do not severely bend, kink, or stretch the lead.
Do not use surgical instruments to grasp the lead or connector pins.
Use the following steps to position the lead:
1. After the lead tip is passed into the atrium, advance the lead through the tricuspid valve. Replace the straight stylet with a gently curved stylet to add control when maneuvering the lead through the tricuspid valve. Caution: Do not use a sharp object to impart a curve to the distal end of the stylet. Imparting a curve to the stylet can be accomplished with a smooth-surface, sterile instrument (Figure 4).
Figure 4.
Note: When you pass the lead tip through the tricuspid valve
or chordae tendineae, it may be difficult due to the flexible nature of the lead body. Rotate the lead body as the tip passes through the valve to facilitate passage.
2. After the lead tip is in the ventricle, the curved stylet may be replaced with a straight stylet. Withdraw the stylet slightly, to avoid using excessive tip force while achieving final electrode position. Avoid known infarcted or thin wall areas to minimize the occurrence of perforation.

9.4 Taking electrical measurements and defibrillation efficacy measurements

Caution: Prior to taking electrical or defibrillation efficacy
measurements, move objects made from conductive materials, such as guide wires, away from all electrodes. Metal objects, such as guide wires, can short a lead and an active implantable device, causing electrical current to bypass the heart and possibly damage the implantable device and lead.
Caution: The ACI tool reduces the risk of connector damage, and reduces the risk of bridging and shorting that may occur while taking electrical measurements during implant. The potential for connector damage, bridging, and shorting is due to variations in analyzer cable terminals, as well as to the connector ring width and the proximity of the rings on the DF4 connector.
Note: The ACI tool may be removed or attached at any time during the procedure using the slit on the side of the tool (see Figure 5).
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Figure 5.
1 Removing the ACI tool from the connector pin 2 Removing the ACI tool from the stylet using the slit on the side of the
tool
Use the following steps to take electrical measurements:
1. Ensure that the lead connector is completely inserted into the ACI tool. The connector pin will be completely accessible if the ACI tool is properly attached (see Figure 6).
Figure 6.
2. Attach a surgical cable to the ACI tool. Line up the cable clips with the contacts on the ACI tool to ensure that accurate readings are obtained. (See Figure 13 for specific contacts.)
3. Use a testing device, such as a pacing system analyzer, for obtaining electrical measurements (see Table 2 for recommended measurements). For information on the use of the testing device, consult the product literature for that device.
4. After the electrical measurements are complete, remove the surgical cable from the ACI tool before removing the tool from the lead.
In order to demonstrate reliable defibrillation efficacy, obtain final defibrillation measurements for the lead system.

Table 2. Recommended measurements at implant (when using a pacing system analyzer)

Measurements required Acutea lead system
Capture threshold (at 0.5 ms pulse width)
Pacing impedance 200–1000 Ω 200–1000 Ω
≤1.0 V ≤3.0 V
Chronicb lead sys-
tem
Table 2. Recommended measurements at implant
(when using a pacing system analyzer) (continued)
Measurements required Acutea lead system
Filtered R-wave amplitude (during sinus rhythm)
Slew rate ≥0.75 V/s ≥0.45 V/s
a
<30 days after implant.
b
>30 days after implant.
≥5 mV ≥3 mV
Chronicb lead sys-
tem
If initial electrical measurements deviate from the recommended values, it may be necessary to repeat the testing procedure 15 min after final positioning. Initial electrical measurements may deviate from the recommended values:
Initial impedance values may exceed the measuring capabilities of the testing device, resulting in an error message.
Values may vary depending upon lead type, implantable device settings, cardiac tissue condition, and drug interactions.
If electrical measurements do not stabilize to acceptable levels, it may be necessary to reposition the lead and repeat the testing procedure.
In order to keep patient morbidity and mortality to a minimum, patients should be rescued promptly with an external defibrillator if the implanted lead system fails to terminate a VF episode. At least 5 min should elapse between VF inductions.
For more information about obtaining electrical measurements, consult the product documentation supplied with the testing device.

9.5 Anchoring the lead

Caution: Use care when anchoring the lead.
Use only nonabsorbable sutures to anchor the lead.
Do not attempt to remove or cut the anchoring sleeve from the lead body.
During lead anchoring, take care to avoid dislodging the lead tip.
Do not secure sutures so tightly that they damage the vein, lead, or anchoring sleeve (Figure 7).
Do not tie a suture directly to the lead body (Figure 7).
Figure 7.
Use the following steps to anchor the lead using all 3 grooves:
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Note: The anchoring sleeves contain a radiopaque substance, which allows visualization of the anchoring sleeve on a standard x-ray and may aid in follow-up examinations.
1. Position the distal 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 8).
Figure 8.
3. Use at least one additional suture in one of the grooves to secure the anchoring sleeve and lead body to the fascia.
4. A second anchoring sleeve is provided with leads that are 85 cm or longer. For abdominal implants, the redundant lead body (for example, a curve for strain relief) should be placed just proximal to the first anchoring sleeve. Then, the second anchoring sleeve may be lightly sutured to the lead body and fascia to hold the curve in place. This procedure helps isolate the vein entry site from tension on the proximal end of the lead body.
5. A slit anchoring sleeve may be used in the device pocket to secure excess lead length. First, secure the anchoring sleeve to the lead body. Then, orient the slit toward the fascia and secure the anchoring sleeve to the fascia with sutures.

9.6 Connecting the lead

Figure 9. Lead connector pin viewing area

1 Lead tip extends past setscrew block; lead connector pin is visible in
pin viewing area (color band may be used to verify full lead insertion) 2 Setscrew block, located behind grommet 3 Lead

9.7 Placing the device and lead into the pocket

Caution: Use care when placing the device and leads into
the pocket.
Ensure that the leads do not leave the device at an acute angle.
Do not grip the lead or device with surgical instruments.
Do not coil the lead. Coiling the lead can twist the lead body and may result in lead dislodgement (Figure 10).
Figure 10.
Use the following steps to connect the lead to an implantable device:
1. Make sure that the stylet and all accessories have been completely removed. When removing the accessories, grip the lead firmly just below the ACI tool on the connector to prevent dislodgement.
2. Push the lead or plug into the header block until the color band on the tip of the lead connector pin is visible in the pin viewing area (see Figure 9). The color band will be visible when the lead is fully inserted. Consult the product literature packaged with the implantable device for instructions on proper lead connections.
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Use the following steps to place the device and leads into the pocket:
1. To prevent undesirable twisting of the lead body, rotate the device to loosely wrap the excess lead length (Figure 11).
Figure 11.
2. Insert the device and leads into the pocket.
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3. Before closing the pocket, verify sensing, pacing, cardioversion, and defibrillation efficacy.

9.8 Post-implant evaluation

After implant, monitor the patient’s electrocardiogram until the patient is discharged. If a lead dislodges, it usually occurs during the immediate postoperative period.
Recommendations for verifying proper lead positioning include x-rays and pacing and sensing thresholds taken at pre-hospital discharge, 3 months after implant, and every 6 months thereafter.
In the event of a patient death, explant all implanted leads and devices and return them to Medtronic with a completed Product Information Report form. Call the appropriate phone number on the back cover if there are any questions on product handling procedures.

10 Specifications (nominal)

10.1 Detailed device description

Table 3. Specifications (nominal)

Parameter Model 6946M
Type Quadripolar
Position Right ventricle
Fixation Tined
Length 20–110 cm
Connector Quadripolar/true
Materials Conductors: MP35N coil
Tip electrode (pace, sense): Sintered platinum alloy with Tita-
DF4 pin and rings: MP35N
Steroid Type: Dexamethasone acetate
Conductor resistances
Diameters Lead body: 2.8 mm
Pacing (unipolar): 27.9 Ω (62 cm)
bipolar:
Insulation: Silicone, PTFE, ETFE
Overlay: Polyurethane
Seal Zone: PEEK
Ring electrode
(pace, sense):
RV/SVC coils: Platinum-clad tantalum
DF4 pin: MP35N
Amount: 272 µg
Steroid binder: Silicone
Pacing (bipolar): 29.3 Ω (62 cm)
Defibrillation: 1.4 Ω (62 cm)
Four-pole inline (DF4–LLHH)
MP35N composite cables
nium Nitride (TiN) coating
Platinum alloy with Titanium Nitride (TiN) coating
Tip: 2.8 mm
Table 3. Specifications (nominal) (continued)
Parameter Model 6946M
Lead introducer (recommended size)
without guide wire: 3.0 mm (9.0 French)
with guide wire: 3.7 mm (11 French)

Figure 12. 6946M distal lead components

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1 Tip electrode; surface area: 2.5 mm 2 Ring electrode; surface area: 25.2 mm 3 RV coil electrode; length: 57 mm; surface area: 614 mm2; electrical
shadow area: 506 mm
4 SVC coil electrode; length: 80 mm; surface area: 860 mm2; electrical
shadow area: 709 mm
5 Anchoring sleeve; leads 85 cm or longer have 2 anchoring sleeves
2
2
2
2

Figure 13. Model 6946M proximal lead components

5 RV contact 6 Ring (+) contact 7 Tip (-)

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 more information, contact your local Medtronic representative, or call or write Medtronic at the appropriate telephone number or address listed on the back cover.

13 Explanation of symbols on package labeling

Refer to the package labels to see which symbols apply to this product.

Table 4. Explanation of symbols on package labeling

Symbol Explanation
Conformité Européenne (European Conformity). This symbol means that the device fully complies with AIMD Directive 90/385/EEC (0123).
1 AccuRead tool 2 Connector pin 3 Stylet 4 SVC contact
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Do not use if package is damaged
Do not reuse
Upper limit of temperature
Open here
Sterilized using ethylene oxide
Caution
Consult instructions for use
Date of manufacture
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Table 4. Explanation of symbols on package labeling (continued)
EC REP
Symbol Explanation
Table 4. Explanation of symbols on package labeling (continued)
Symbol Explanation
Manufacturer
Authorized representative in the European com­munity
Use by
Reorder number
Serial number
Lot number
Package contents
Product documentation
Accessories
Inner diameter
Lead
Steroid eluting
Lead introducer
Lead introducer with guide wire
Lead length
Transvenous ventricular lead
Transvenous lead with two defibrillation electrodes
Pace
Sense
Defibrillation
Tined
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Medtronic, Inc.
*M950936A001*
710 Medtronic Parkway Minneapolis, MN 55432 USA www.medtronic.com +1 763 514 4000
Medtronic USA, Inc.
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Technical manuals
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