SPECIFICATIONS - Medtronic

1 Physical CharacteristicsPolarityBipolarShapeStrai ghtChamberVentricle or AtriumStandard Lengths49, 59, 69, 74 cmConnectorI S -1 B IMaterialsInsulatorPolyurethane (outer), Silicone and ETFE (inner)ConductorMP35 NHelix Electrode Titanium Nitride Coated Platinum AlloyRing ElectrodeTitanium Nitride Coated Platinum mm ( Fr)Recommended Guide CatheterTip DesignWorking LengthFixed Shape C315 CathetersC315-H2020 cmC315-J C315-S 4 C315-S530 cmC315-S10 C315-H4 040 cmC315-H I S43 cmDeflectable C304 CathetersC304S5930 cmC304L6940 cmC 3 0 4 X L 7445 cmSPECIFICATIONSS electSecure 3830 LeadElectrode ConfigurationFixed Helix Screw Electrode Surface mm2 Ring16 .9 m m2 Helix mmOther CharacteristicsSteroidBeclomethasone dipropionateTip-to-ring Spacing9 mmUnipolar Conductor Resistance29 6 (69 cm)BipolarConductor Resistance99 22 (69 cm)Serial PrefixLFFB rief Statement Medtronic Pacing and Sensing LeadsIndications Medtronic leads have application where implantable atrial or ventricular, single chamber or dual chamber pacing systems are indicated.

2 Leads are intended for pacing and sensing in the atrium or Medtronic leads are contraindicated for: Ventricular use in patients with tricuspid valvular disease or a tricuspid mechanical heart valveThe SelectSecure Model 3830 lead is also contraindicated for the following: Patients for whom a single dose of 40. g of beclomethasone dipropionate may be contraindicated Patients with obstructed or inadequate vasculature for intravenous catheterizationWarnings/Precautions 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.

3 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 with metal implants such as pacemakers, implantable cardioverter def ibrillators (ICDs), and accompanying leads should not receive diathermy treatment. The interaction between the implant and diathermy can cause tissue damage, f ibrillation, or damage to the device components, which could result in serious injury, loss of therapy, or the need to reprogram or replace the the SelectSecure Model 3830 lead, total patient exposure to beclomethasone 17,21-dipropionate should be considered when implanting multiple leads.

4 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 Complications Potential complications include, but are not limited to, valve damage, f ibrillation and other arrhythmias, thrombosis, thrombotic and air embolism, cardiac perforation, heart wall rupture, cardiac tamponade, muscle or nerve stimulation, pericardial rub, infection, myocardial irritability, and pneumothorax. Other potential complications related to the lead may include lead dislodgement, lead conductor fracture, insulation failure, threshold elevation, or exit the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events.

5 For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at : Federal law (USA) restricts this device to sale by or on the order of a EN 2016 Medtronic . Minneapolis, MN. All Rights Reserved. Printed in USA. 09/2016 Medtronic 710 Medtronic Parkway Minneapolis, MN 55432-5604 USA Toll-free in USA: : +