Indications, Safety, and Warnings
Indications
The Model 3930M family of leads are intended for use in the right ventricle (RV) or for placement in the left bundle branch area as an alternative to right ventricular stimulation sensing, pacing, cardioversion, and defibrillation when a cardiac implantable electronic device is indicated to treat patients who have experienced, or are at significant risk of developing, life-threatening tachyarrhythmias.
This includes adolescent pediatric patients who are at least 30 kg and are also at least 12 years of age, and whose cardiac anatomy is conducive to RV coil placement.
Contraindications
The Model 3930M family of leads are contraindicated for use in the following situations:
Non-right ventricular use – The lead is contraindicated for non-right ventricular implant sites including the His bundle and the atrial side of the tricuspid valve annulus.Tricuspid valvular disease or mechanical tricuspid valve – The lead is contraindicated in patients with tricuspid valvular disease or a mechanical tricuspid valve.Steroid use – The lead is contraindicated in patients for whom a single dose of 1.0 mg of dexamethasone acetate may be contraindicated.Transient ventricular tachyarrhythmias – The lead is contraindicated if tachyarrhythmias with transient or reversible causes exist, including the following known issues: acute myocardial infarction, drug intoxication, drowning, electric shock, electrolyte imbalance, hypoxia, sepsis.Intravenous Catheterization – The leads are contraindicated in patients with obstructed or inadequate vasculature for intravenous catheterization.
Warnings and Precautions
Handling the lead – Handle the lead with care at all times. Do not implant the lead if it is damaged. Do not attempt to straighten or realign the helix if the helix is deformed. Return the lead to your Medtronic representative in either event.
Repositioning or removal of an acute lead – Successfully repositioning the lead depends on recreating the angle and advancement of the catheter present at the time of initial helix deployment at implant (relative to the lead helix and endocardium). Proper orientation helps transfer torque to the helix. This increases the likelihood of successfully disengaging the helix from the endocardium. Improper removal of the lead by pulling may result in avulsion of the endocardium.
Extraction or removal of a chronic lead – Proceed with caution if a chronically implanted lead must be removed or extracted. Lead extraction procedures should be consistent with the most recent editions of HRS or EHRA expert consensus statements regarding cardiovascular implantable electrode device lead management and extraction. Market released extraction tools or clinically recognized techniques may be used to help facilitate extraction. When the risk of lead extraction outweighs the benefit, it may be preferable to abandon unused leads and leave in place. Return all removed leads, unused leads, or lead sections to Medtronic for analysis.
Connector compatibility – Although Medtronic lead connectors conform to International Connector Standards, this lead has not been tested for use with non-Medtronic devices. The known potential adverse consequences of using such a combination may include undersensing of cardiac activity, failure to deliver necessary therapy, or an intermittent electrical connection.
Electrophysiologic testing – Electrophysiologic evaluation and testing should be performed at the discretion of the physician taking into consideration the current clinical guidelines.
Potential Adverse Events
The following are known potential complications associated with the use of this product: Allergic reaction; AV fistula; Bradyarrhythmia; Cardiac arrest; Cardiac inflammation; Cardiac perforation; Cardiac tamponade; Cardiac valve damage; Discomfort; Dislodgement; Dizziness; Dyspnea; Embolism; Erosion; Extracardiac stimulation; Excessive fibrotic tissue growth; Fever; Heart block; Heart failure decompensation (hospitalization); Hematoma; Hemorrhage; Hemothorax; Hiccups; Hospitalization; Inappropriate shock; Infection; Insulation failure; Lead fracture; Lethargy; Loss of capture; Loss of pacing; Mental anguish; Nerve damage; Oversensing; Palpitations; Pericardial effusion; Pneumothorax; Return of cardiac symptoms; Septal wall perforation; Seroma; Skeletal muscle sensation or twitching; Skin disorders; Stroke; SVC tear; Syncope; Tachyarrhythmia; Threshold elevation; Thrombosis; Tissue trauma; Toxic reaction; Tricuspid valve regurgitation; Undersensing; Vascular tear; Venous occlusion; Vessel perforation.
See the MRI SureScan Technical Manual before performing an MRI scan. Consult 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 Medtronic’s website at www.medtronic.com or www.mrisurescan.com .
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
US-CV-2600618 v1.0
