INDICATIONS, SAFETY, AND WARNINGS MRI SureScan Pacing Leads

Indications

Medtronic leads have application where implantable atrial and/or ventricular, single or dual chamber pacing systems are indicated. Leads are intended for pacing and sensing in the right atrium and/or ventricle. MRI SureScan™ leads (which include specified lengths of Models 5076, 4076, 4074, 4574, 5086MRI and 3830; consult individual lead model technical manuals for more detail) are indicated for use as a system consisting of an indicated Medtronic MRI SureScan device, implanted with SureScan leads. A complete system is required for use in the MRI environment.


Contraindications

Use of ventricular transvenous leads is contraindicated in patients with tricuspid valvular disease and/or patients with mechanical tricuspid heart valves. 

Do not use in patients for whom a single dose of dexamethasone acetate and/or dexamethasone sodium acetate or beclomethasone dipropionate may be contraindicated (applies to all leads that contain these steroid configurations; see model manuals for specific steroid and dosage).

The SelectSecure™ Model 3830 Lead is also contraindicated for the following: Patients with obstructed or inadequate vasculature for intravenous catheterization.


Warnings and Precautions

People with metal implants such as pacemakers, implantable cardioverter defibrillators (ICDs) and accompanying leads should not receive certain forms of diathermy treatment. Diathermy treatments may result in serious injury or damage to an implanted device and lead system. Some lead models allow the use of therapeutic ultrasound; consult individual lead model technical manuals for more detail.

For the SelectSecure Model 3830 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 3830 lead have not been studied.

Do not use magnetic resonance imaging (MRI) on patients who have non-MR conditional versions/lengths of these leads implanted as part of a complete SureScan System. MRI can induce currents on implanted leads, potentially causing tissue damage and the induction of tachyarrhythmias.

MRI SureScan Leads only: A complete SureScan pacing or defibrillation system is required for use in the MR environment. Before performing an MRI scan, refer to the MRI Technical Manual for 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; no broken leads or leads with intermittent electrical contact as confirmed by lead impedance history; a SureScan defibrillation system implanted in the left or right pectoral region; pacing capture thresholds of ≤ 2.0 V at a pulse width of 0.4 ms; 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.

Patients may be scanned using a horizontal field, cylindrical bore, clinical 1.5T or 3T MRI system for hydrogen proton imaging.


Potential Complications

Potential patient-related complications related to the use of transvenous leads include, but are not limited to, valve damage, fibrillation and other arrhythmias, thrombolytic and air embolism, cardiac perforation, heart wall rupture, cardiac tamponade, muscle or nerve stimulation, pericarditis, pericardial rub, infection, myocardial irritability, thrombosis and pneumothorax. Other potential lead-related complications may include exit block, lead dislodgement, lead fracture, insulation failure, and threshold elevation.

The SureScan pacing, ICD, or CRT-D system has been designed to minimize potential complications in the MRI environment. Potential MRI complications 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.

See the appropriate Device MRI SureScan Technical Manual before performing an MRI Scan and Lead Technical Manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at www.medtronic.com or www.mrisurescan.com.

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