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INDICATIONS, SAFETY, AND WARNINGS Attain Left-Heart Leads

Attain Ability™ and Attain™ Performa™ MRI SureScan™ Leads Indications

The Attain Ability 4196, 4296, and 4396 steroid eluting, dual electrode, IS-1 transvenous leads are indicated for chronic pacing and sensing in the left ventricle via the cardiac vein, when used in conjunction with a compatible Medtronic Cardiac Resynchronisation Therapy (CRT) system. Extended bipolar pacing is available using these leads in combination with a compatible CRT-D system and RV defibrillation lead or with a compatible CRT-P system and RV pacing lead. Unipolar pacing is available using the leads in combination with a compatible CRT-P system. The Attain Performa 4298, 4398, 4598 steroid eluting, quadripolar electrode, IS4 transvenous leads are indicated for chronic pacing and sensing in the left ventricle via the cardiac vein, when used with a compatible Medtronic Cardiac Resynchronisation Therapy (CRT) system. Extended bipolar pacing is available using this lead in combination with a compatible CRT-D system and RV defibrillation lead.

The Attain Ability MRI SureScan and Attain Performa MRI SureScan Leads are part of the Medtronic SureScan Implantable Cardioverter Defibrillator with Cardiac Resynchronisation (CRT-D) system. A complete SureScan CRT-D system is required for use in the MR environment and includes a Medtronic SureScan device connected to Medtronic SureScan leads.

Contraindications

The Attain Ability leads are contraindicated for the following: Coronary vasculature—These leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated

by venogram. Steroid use—Do not use in patients for whom a single dose of 232 μg of dexamethasone acetate cannot be tolerated.

The Attain Performa leads are contraindicated for the following: Coronary vasculature—These leads are contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram. Steroid use—Do not use in patients for whom a single dose of 288 μg of dexamethasone acetate may be contraindicated.

Warnings and Precautions

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.

A complete SureScan CRT-D system is required for use in the MR environment. Before performing an MRI scan, refer to the SureScan MRI Technical Manual for important information about procedures and MRI-specific warnings and precautions. Patients and their implanted systems must be screened to meet the following requirements for MRI: no implanted lead extenders, lead adaptors, or abandoned leads; for patients with multiple MR-Conditional devices present, the MR labeling conditions for all implants are satisfied; no broken leads or leads with intermittent electrical contact as confirmed by lead impedance history; the SureScan CRT-D system is implanted in the left or right pectoral region; the CRT-D device is operating within the projected service life; no diaphragmatic stimulation at a pacing output of 5.0 V and at a pulse width of 1.0 ms in patients whose device will be programmed to an asynchronous pacing mode when MRI SureScan is programmed to On. For pacemaker-dependent patients, it is not recommended to perform an MRI scan if the right ventricular (RV) lead pacing capture threshold is greater than 2.0 V at 0.4 ms. A higher pacing capture threshold may indicate an issue with the implanted lead.

Patients may be scanned using a horizontal field, cylindrical bore, clinical 1.5T MRI system with operating frequency of 64 MHz, maximum spatial gradient ≤ 20 T/m, and maximum gradient slew rate performance per axis ≤ 200 T/m/s. Scanner must be operated in Normal Operating Mode (whole body averaged specific absorption rate (SAR) ≤ 2.0 W/kg, head SAR ≤ 3.2 W/kg). 3T scanners must be operated in First Level Controlled Operating Mode or Normal Operating Mode.  B1+RMS must be ≤ 2.8 μT when the isocentre (centre of the bore) is inferior to the C7 vertebra.  Scans can be performed without B1+RMS restriction when the isocentre is at or superior to the C7 vertebra.

The Model 4196, 4296, and 4396 leads were designed for optimal pacing when used in a unipolar or extended bipolar configuration. The standard bipolar configuration may result in markedly elevated pacing thresholds or produce anodal stimulation.

Potential Complications

Potential complications related to the use of transvenous leads include, but are not limited to, the following patient-related conditions: air embolism; avulsion or other damage to the endocardium, valve, or vein (particularly in fragile hearts); cardiac dissection; cardiac perforation; cardiac tamponade; coronary sinus dissection; death; endocarditis; erosion through the skin; extracardiac muscle or nerve stimulation; fibrillation or other arrhythmias; heart block; heart wall or vein wall rupture; hematoma/seroma; infection; lead conductor fracture or insulation failure; lead dislodgement; myocardial irritability; myopotential sensing; pericardial effusion; pericardial rub; pericarditis; pneumothorax; rejection phenomena (local tissue reaction, fibrotic tissue formation); threshold elevation or exit block; thrombosis; thrombotic embolism.

Potential MRI complications for the SureScan system include, but are not limited to, lead electrode heating and tissue damage resulting in loss of sensing or capture or both, or induced currents on leads resulting in continuous capture, VT/VF, and/or hemodynamic collapse; spontaneous tachyarrhythmia occurring during the scan that is not detected and treated because tachyarrhythmia detection is suspended while MRI SureScan is programmed to On; potential for VT/VF induction when the patient is programmed to an asynchronous pacing mode during MRI SureScan; device heating resulting in tissue damage in the implant pocket or patient discomfort or both; or damage to the functionality or mechanical integrity of the device resulting in the inability of the device to communicate with the programmer.

See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. If using an MRI SureScan® device, see the MRI SureScan® technical manual before performing an MRI. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu.

For applicable products, consult instructions for use on www.medtronic.com/manuals. Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser.

ATTAINTM StarFix Model 4195 Lead

Indications

The Attain StarFix Model 4195 steroid eluting, transvenous lead is intended for chronic pacing and sensing of the left ventricle via a cardiac vein, when used in conjunction with a compatible implantable pulse generator or implantable cardiac defibrillator.

Contraindications

This lead is contraindicated for patients with coronary venous vasculature that is inadequate for lead placement, as indicated by venogram.  Do not use in patients for whom a single dose of 30 μg (micrograms) of beclomethasone dipropionate (BDP) cannot be tolerated.

Warnings/Precautions

  • Leads, stylets, and guidewires should be handled with great care at all times.  When using this lead, only use compatible stylets (stylets with downsized knobs and are 3 cm shorter than the lead length). Verify that the stylet does not extend beyond the lead tip prior to inserting the lead in the delivery system. Implanting the lead with the stylet extending beyond the lead tip could cause injury or perforation of the cardiac vein or heart.
  • Output pulses, especially from unipolar leads, may adversely affect device sensing capabilities.
  • Back-up pacing should be readily available during implant. Use of leads may cause heart block.
  • For the Model 4195 lead, total patient exposure to beclomethasone 17,21-dipropionate should be considered when implanting multiple leads.  No drug interactions with inhaled beclomethasone 17,21-dipropionate have been described. Drug interactions of beclomethasone 17,21-dipropionate with the Model 4195 lead have not been studied.
  • People with metal implants such as pacemakers, implantable cardioverter defibrillators (ICDs), and accompanying leads should not receive diathermy treatment. The interaction between the implant and diathermy can cause tissue damage, fibrillation, or damage to the device components, which could result in serious injury, loss of therapy, or the need to reprogram or replace the device.
  • Do not use magnetic resonance imaging (MRI) on patients who have this device. MRI can induce currents on implanted leads, potentially causing tissue damage and the induction of tachyarrhythmias.
  • Always use an acute retention clip to reposition or remove the lead. Always attempt to undeploy the lobes before repositioning or removing the lead. If a lead must be removed or repositioned, consider referring the case to an experienced extraction centre. Do not implant the acute retention clip.
  • Previously implanted pulse generators, implantable cardioverter-defibrillators, and leads should generally be explanted.

Potential Complications

Potential complications related to the use of transvenous leads include, but are not limited to the following patient-related conditions: avulsion of the endocardium, valve, or vein, cardiac dissection, cardiac perforation, cardiac tamponade, coronary sinus dissection, death, endocarditis and pericarditis, erosion through the skin, extracardiac muscle or nerve stimulation, fibrillation or other arrhythmias, heart block, heart wall or vein wall rupture, hematoma/seroma, infection, myocardial irritability, myopotential sensing, pericardial effusion, pericardial rub, pneumothorax, rejection phenomena, threshold elevation, thrombosis, thrombotic or air embolism, and valve damage.

See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. If using an MRI SureScan® device, see the MRI SureScan® technical manual before performing an MRI. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu.

For applicable products, consult instructions for use on www.medtronic.com/manuals. Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser.