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DEXTRUS™ Pacing Lead

Indications, Safety and Warnings

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Indications

The DEXTRUS™ transvenous, steroid-eluting, active fixation endocardial leads are indicated for permanent pacing and sensing. Active fixation pacing leads with a bipolar (BP) IS-1 connector configuration are designed for use in conjunction with implantable pulse generators with IS-1 headers. The leads may be used with single or dual chamber pacing systems. The DEXTRUS lead models are intended for placement in either the right atrium or right ventricle.

Contraindications

Transvenous endocardial pacing leads are contraindicated in the presence of severe tricuspid valvular disease and in patients with mechanical tricuspid heart valves. The DEXTRUS lead is additionally contraindicated for patients who cannot tolerate a single systemic dose of up to 1.3 mg of dexamethasone acetate (DXA).

Warnings and Precautions

Potentially Harmful Therapeutic and Diagnostic Procedures As an implanted pacing lead is a direct, low resistance path to the myocardium for electrical current, the observance of high standards of electrical safety is required. Electrosurgical instruments, for example, could generate voltages of such amplitude that a direct coupling between the tip of the electrocautery device and the implanted lead may result, possibly inducing myocardial lesions or serious cardiac arrhythmias (e.g., fibrillation). Some therapeutic and diagnostic procedures (e.g., diathermy, MRI, electrocautery) may result in latent damage to the pacing system. This damage may not be detected when testing the pacemaker function immediately after the procedure, but may become evident at a later time, resulting in pacing system malfunction or failure. For single patient use only. Do not reuse, reprocess, or resterilize.

Prevention of Leakage Current Conduction

Pulse generators and testing equipment connected to the lead must be battery-powered. Proper grounding of linepowered devices in the vicinity of the patient is essential to prevent leakage currents arising from such devices to be conducted via the lead’s terminal or any other non-insulated part.

Necessary Equipment for Implantation

During implantation the ECG should be recorded; a pacing system analyzer (PSA) and defibrillation equipment should always be readily available.

Handling the Lead

The lead should be handled very carefully at all times. Any severe application of force (bending, stretching, crimping, etc.) may permanently damage the lead. The metal portion of the lead connector should not be touched.

Lead/Pulse Generator Compatibility

Because of the numerous available 3.2 mm configurations, e.g., the IS-1 and VS-1 standards, lead/pulse generator compatibility should be confirmed with the pulse generator and/or lead manufacturer prior to the implantation of a pacing system.

Extending/Retracting the Fixation Helix

In the event of previous handling or repositioning of the lead, more than the minimum number of rotations may be necessary to fully extend or retract the helix. Full helix extension should always be verified through fluoroscopy.

Chronic Repositioning

It is generally recommended that a chronically implanted endocardial lead not be explanted. Chronic repositioning or removal of active fixation leads may be difficult due to the presence of blood or fibrotic tissue in the helix. If it becomes necessary to remove the lead without successfully retracting the fixation helix, the lead should be rotated counter-clockwise during withdrawal in order to minimize the risk of endothelial laceration. If it becomes necessary to abandon a lead, the connector pin should be capped to prevent the transmission of electrical signals to the heart.

Suture Sleeve

Always use a suture sleeve when implanting a lead. Use of the suture sleeve, which is provided with the lead, will lessen the possibility of lead dislodgment and protect the lead body from damage by a securing ligature.

Potential Adverse Events

Potential complications include, but are not limited to: thrombosis, embolism, body rejection phenomena, cardiac tamponade, pneumothorax, muscle/nerve stimulation, valve damage, fibrillation, infection, skin erosion, ventricular ectopy and death. Lead perforation through the myocardium has been rarely observed. In rare cases, severe complications or device failures can occur.

Refer to the physician’s manual(s) for specific indications, contraindications, warning/precautions and adverse events. Rx only. 
(Rev. H)

 

 

 

 

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